Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-01-01 @ 3:44 AM
Study NCT ID:
NCT06980428
Status:
RECRUITING
Last Update Posted:
2025-12-01
First Post:
2025-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4954 in Healthy Adult Participants With or Without Elevated Lipoprotein (a) (Lp[a]) Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-28', 'studyFirstSubmitDate': '2025-05-19', 'studyFirstSubmitQcDate': '2025-05-19', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'From Screening (Day -28 to Day -2) to Follow-up visit (Up to Day 29±2 days)', 'description': 'To assess the safety and tolerability of AZD4954 following oral administration of SAD (Part A).'}, {'measure': 'Part B: Number of participants with AEs and SAEs', 'timeFrame': 'From Screening (Day -28 to Day -2) to Follow-up visit (Up to Day 49±2 days)', 'description': 'To assess the safety and tolerability of AZD4954 following oral administration of MAD (Part B).'}], 'secondaryOutcomes': [{'measure': 'Part A: Area under concentration-time curve from time 0 to infinity (AUCinf)', 'timeFrame': 'Up to Day 29±2 days', 'description': 'To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954.'}, {'measure': 'Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)', 'timeFrame': 'Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days', 'description': 'To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954.'}, {'measure': 'Part B: Area under concentration-time curve in the dosing interval (AUCtau)', 'timeFrame': 'Up to Day 49±2 days', 'description': 'To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954.'}, {'measure': 'Dose normalized AUClast (AUClast/D)', 'timeFrame': 'Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days', 'description': 'To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954.'}, {'measure': 'Dose normalized AUCinf (AUCinf/D)', 'timeFrame': 'Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days', 'description': 'To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954.'}, {'measure': 'Part B: Dose normalized AUCtau (AUCtau/D)', 'timeFrame': 'Up to Day 49±2 days', 'description': 'To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954.'}, {'measure': 'Apparent total body clearance (CL/F)', 'timeFrame': 'Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days', 'description': 'To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954.'}, {'measure': 'Maximum observed drug concentration (Cmax)', 'timeFrame': 'Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days', 'description': 'To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954.'}, {'measure': 'Dose normalized Cmax (Cmax/D)', 'timeFrame': 'Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days', 'description': 'To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954.'}, {'measure': 'Terminal elimination half-life (t1/2λz)', 'timeFrame': 'Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days', 'description': 'To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954.'}, {'measure': 'Time of last quantifiable concentration (tlast)', 'timeFrame': 'Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days', 'description': 'To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954.'}, {'measure': 'Time to reach maximum observed concentration (tmax)', 'timeFrame': 'Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days', 'description': 'To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954.'}, {'measure': 'Apparent volume of distribution based on the terminal phase (Vz/F)', 'timeFrame': 'Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days', 'description': 'To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954.'}, {'measure': 'Individual and cumulative amount of unchanged drug excreted into urine from time t1 to time t2 (Ae[t1-t2])', 'timeFrame': 'Part A: Up to Day 15; Part B: Up to Day 22', 'description': 'To characterize the single dose and/or steady state urine pharmacokinetics of AZD4954 following oral administration of AZD4954.'}, {'measure': 'Cumulative amount of unchanged drug excreted into urine (Aeinf)', 'timeFrame': 'Part A: Up to Day 15; Part B: Up to Day 22', 'description': 'To characterize the single dose and/or steady state urine pharmacokinetics of AZD4954 following oral administration of AZD4954.'}, {'measure': 'Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 (fe[t1-t2])', 'timeFrame': 'Part A: Up to Day 15; Part B: Up to Day 22', 'description': 'To characterize the single dose and/or steady state urine pharmacokinetics of AZD4954 following oral administration of AZD4954.'}, {'measure': 'Renal clearance (CLR)', 'timeFrame': 'Part A: Up to Day 15; Part B: Up to Day 22', 'description': 'To characterize the single dose and/or steady state urine pharmacokinetics of AZD4954 following oral administration of AZD4954.'}, {'measure': 'Part B: Absolute change from baseline in serum Lp(a)', 'timeFrame': 'Up to Day 49±2 days', 'description': 'To evaluate the pharmacodynamics of AZD4954 by assessment of Lp(a) levels following repeated oral dosing.'}, {'measure': 'Part B: Relative change from baseline in serum Lp(a)', 'timeFrame': 'Up to Day 49±2 days', 'description': 'To evaluate the pharmacodynamics of AZD4954 by assessment of Lp(a) levels following repeated oral dosing.'}, {'measure': 'Part B: Absolute change from baseline in Lp(a) intact assay', 'timeFrame': 'Up to Day 49±2 days', 'description': 'To evaluate the pharmacodynamics of AZD4954 by assessment of Lp(a) levels following repeated oral dosing.'}, {'measure': 'Part B: Relative change from baseline in Lp(a) intact assay', 'timeFrame': 'Up to Day 49±2 days', 'description': 'To evaluate the pharmacodynamics of AZD4954 by assessment of Lp(a) levels following repeated oral dosing.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dyslipidemia', 'Lipoprotein(a)'], 'conditions': ['Healthy Participants']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of AZD4954 in healthy participants with or without elevated Lipoprotein(a) (Lp\\[a\\]) levels.', 'detailedDescription': 'This is a first time in human, placebo-controlled, single and multiple ascending dose (SAD and MAD) study in healthy male and female (of non-childbearing potential) participants (Part A) or healthy participants (of non-childbearing potential) with elevated Lp(a) levels (≥ 30 mg/dL; Part B).\n\nThe study consists of 2 parts: Part A (SAD) and Part B (MAD).\n\nPart A of the study will consist of Part A1 and Part A2, comprising:\n\n* A Screening Period of maximum 28 days.\n* Admission to study site (Day -1).\n* A Treatment Period (Day 1 to Day 15 at the study site) with a single dose of AZD4954 or placebo on Day 1.\n* A Follow-up Visit within 26 to 30 days after the investigational medicinal product (IMP) dose for all cohorts (Day 29 ±2 days).\n\nPart B of the study will comprise:\n\n* A Screening Period of maximum 28 days.\n* Admission to study site (Day -1).\n* A Treatment Period during which participants will receive either AZD4954 or placebo once daily for 21 days (Day 1 to 21) in the global MAD cohorts and for 14 days (Day 1 to 14) in Japanese MAD cohorts.\n* A Follow-up Visit within 26 to 30 days after the last IMP dose (Day 49 ±2 days for the global MAD cohorts and Day 42 ±2 days for the Japanese MAD cohorts).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nParts A and B:\n\n* Participants with plasminogen level (concentration) within normal range at the Screening Visit.\n* All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.\n* Females of non-childbearing potential must be confirmed at the Screening Visit.\n* Sexually active fertile male participants with partners of childbearing potential must adhere to the study specific contraception methods from the time of first administration of study intervention until 3 months after the study Follow-up Visit.\n* Have a body mass index (BMI) between 18 and 35 kg/m2 inclusive.\n* For Japanese and Chinese participants (Parts A and B):\n\n 1. A Japanese participant is defined as having both parents and 4 grandparents who are ethnically Japanese. This includes second and third generation Japanese whose parents or grandparents are living in a country other than Japan.\n 2. A Chinese participant is defined as having both parents and 4 grandparents who are ethnically Chinese. This includes second and third generation Chinese whose parents or grandparents are living in a country other than China.\n\n Only Part B:\n* For Part B (Global MAD Cohorts), at the Screening Visit participants must have elevated Lp(a) ≥ 30 mg/dL.\n\nExclusion Criteria:\n\nParts A and B:\n\n* History of any clinically important disease or disorder.\n* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.\n* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.\n* Participants with known bleeding or coagulation disorders.\n* Participants who have an elevated high-sensitivity C-reactive protein (\\> 3 mg/L) or have a prothrombin time/international normalized ratio (PT/INR) or activated partial thromboplastin time (aPTT) \\> 1.25 times × upper limit normal (ULN).\n* Any clinically important abnormalities in hematology, coagulation, clinical chemistry, urinalysis, abnormal vital signs or abnormal laboratory values.\n* Any positive result on Screening for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).\n* Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead electrocardiogram (ECG) at Screening.\n* Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks prior to the first administration of study intervention."}, 'identificationModule': {'nctId': 'NCT06980428', 'briefTitle': 'A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4954 in Healthy Adult Participants With or Without Elevated Lipoprotein (a) (Lp[a]) Levels', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4954 Following Single and Multiple Ascending Dose Administration to Healthy Participants With or Without Elevated Lp(a) Levels', 'orgStudyIdInfo': {'id': 'D7300C00001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A1: SAD Cohort 1 - AZD4954 (Dose 1)', 'description': 'Participants will receive a single dose of AZD4954 (Dose 1) or matching placebo on Day 1.', 'interventionNames': ['Drug: AZD4954', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A1: SAD Cohort 2 - AZD4954 (Dose 2)', 'description': 'Participants will receive a single dose of AZD4954 (Dose 2) or matching placebo on Day 1.', 'interventionNames': ['Drug: AZD4954', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A1: SAD Cohort 3 - AZD4954 (Dose 3)', 'description': 'Participants will receive a single dose of AZD4954 (Dose 3) or matching placebo on Day 1.', 'interventionNames': ['Drug: AZD4954', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A1: SAD Cohort 4 - AZD4954 (Dose 4)', 'description': 'Participants will receive a single dose of AZD4954 (Dose 4) or matching placebo on Day 1.', 'interventionNames': ['Drug: AZD4954', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A1: SAD Cohort 5 - AZD4954 (Dose 5)', 'description': 'Participants will receive a single dose of AZD4954 (Dose 5) or matching placebo on Day 1.', 'interventionNames': ['Drug: AZD4954', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A1: SAD Optional Cohort 6 - AZD4954 (Dose 6)', 'description': 'Participants will receive a single dose of AZD4954 (Dose 6) or matching placebo on Day 1. This additional cohort may be added depending on the findings.', 'interventionNames': ['Drug: AZD4954', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A1: SAD Cohort 1 (Japanese) - AZD4954 (Dose 2)', 'description': 'Japanese participants will receive a single dose of AZD4954 (Dose 2) or matching placebo on Day 1.', 'interventionNames': ['Drug: AZD4954', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A1: SAD Cohort 2 (Japanese) - AZD4954 (Dose 3)', 'description': 'Japanese participants will receive a single dose of AZD4954 (Dose 3) or matching placebo on Day 1.', 'interventionNames': ['Drug: AZD4954', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A1: SAD Optional Cohort 3 (Japanese) - AZD4954', 'description': 'This additional cohort may be added depending on the findings.', 'interventionNames': ['Drug: AZD4954', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A1: SAD Cohort 1 (Chinese) - AZD4954 (Dose 5)', 'description': 'Chinese participants will receive a single dose of AZD4954 (Dose 5) or matching placebo at the highest dose level on Day 1.', 'interventionNames': ['Drug: AZD4954', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A2: SAD Food Effect Cohort - AZD4954 (Dose 2)', 'description': 'Participants will receive a single dose of AZD4954 (Dose 2) or matching placebo with a high-calorie, high-fat breakfast on Day 1.', 'interventionNames': ['Drug: AZD4954', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Global MAD Cohort 1 - AZD4954 (Dose 1)', 'description': 'Participants will receive multiple doses of AZD4954 (Dose 1) or matching placebo for 21 days.', 'interventionNames': ['Drug: AZD4954', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Global MAD Cohort 2 - AZD4954 (Dose 2)', 'description': 'Participants will receive multiple doses of AZD4954 (Dose 2) or matching placebo for 21 days.', 'interventionNames': ['Drug: AZD4954', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Global MAD Cohort 3 - AZD4954 (Dose 3)', 'description': 'Participants will receive multiple doses of AZD4954 (Dose 3) or matching placebo for 21 days.', 'interventionNames': ['Drug: AZD4954', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Optional Global MAD Cohort 4 - AZD4954', 'description': 'Participants will receive multiple doses of AZD4954 or matching placebo for 21 days. This additional cohort may be added depending on the findings.', 'interventionNames': ['Drug: AZD4954', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: MAD Cohort (Japanese) - AZD4954 (Dose 3)', 'description': 'Japanese participants will receive multiple doses of AZD4954 (Dose 3) or matching placebo for 14 days.', 'interventionNames': ['Drug: AZD4954', 'Drug: Placebo']}], 'interventions': [{'name': 'AZD4954', 'type': 'DRUG', 'description': 'AZD4954 will be administered orally.', 'armGroupLabels': ['Part A1: SAD Cohort 1 (Chinese) - AZD4954 (Dose 5)', 'Part A1: SAD Cohort 1 (Japanese) - AZD4954 (Dose 2)', 'Part A1: SAD Cohort 1 - AZD4954 (Dose 1)', 'Part A1: SAD Cohort 2 (Japanese) - AZD4954 (Dose 3)', 'Part A1: SAD Cohort 2 - AZD4954 (Dose 2)', 'Part A1: SAD Cohort 3 - AZD4954 (Dose 3)', 'Part A1: SAD Cohort 4 - AZD4954 (Dose 4)', 'Part A1: SAD Cohort 5 - AZD4954 (Dose 5)', 'Part A1: SAD Optional Cohort 3 (Japanese) - AZD4954', 'Part A1: SAD Optional Cohort 6 - AZD4954 (Dose 6)', 'Part A2: SAD Food Effect Cohort - AZD4954 (Dose 2)', 'Part B: Global MAD Cohort 1 - AZD4954 (Dose 1)', 'Part B: Global MAD Cohort 2 - AZD4954 (Dose 2)', 'Part B: Global MAD Cohort 3 - AZD4954 (Dose 3)', 'Part B: MAD Cohort (Japanese) - AZD4954 (Dose 3)', 'Part B: Optional Global MAD Cohort 4 - AZD4954']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be administered orally.', 'armGroupLabels': ['Part A1: SAD Cohort 1 (Chinese) - AZD4954 (Dose 5)', 'Part A1: SAD Cohort 1 (Japanese) - AZD4954 (Dose 2)', 'Part A1: SAD Cohort 1 - AZD4954 (Dose 1)', 'Part A1: SAD Cohort 2 (Japanese) - AZD4954 (Dose 3)', 'Part A1: SAD Cohort 2 - AZD4954 (Dose 2)', 'Part A1: SAD Cohort 3 - AZD4954 (Dose 3)', 'Part A1: SAD Cohort 4 - AZD4954 (Dose 4)', 'Part A1: SAD Cohort 5 - AZD4954 (Dose 5)', 'Part A1: SAD Optional Cohort 3 (Japanese) - AZD4954', 'Part A1: SAD Optional Cohort 6 - AZD4954 (Dose 6)', 'Part A2: SAD Food Effect Cohort - AZD4954 (Dose 2)', 'Part B: Global MAD Cohort 1 - AZD4954 (Dose 1)', 'Part B: Global MAD Cohort 2 - AZD4954 (Dose 2)', 'Part B: Global MAD Cohort 3 - AZD4954 (Dose 3)', 'Part B: MAD Cohort (Japanese) - AZD4954 (Dose 3)', 'Part B: Optional Global MAD Cohort 4 - AZD4954']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91206', 'city': 'Glendale', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '34452', 'city': 'Inverness', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.83582, 'lon': -82.33037}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '21225', 'city': 'Brooklyn', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.23039, 'lon': -76.60219}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'centralContacts': [{'name': 'AstraZeneca Clinical Study Information Center', 'role': 'CONTACT', 'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'timeFrame': 'AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.\n\nYes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}