Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-01-01 @ 6:26 PM
Study NCT ID:
NCT04868292
Status:
COMPLETED
Last Update Posted:
2021-11-17
First Post:
2021-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess the Intrapulmonary Pharmacokinetics of SPR206 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-16', 'studyFirstSubmitDate': '2021-04-13', 'studyFirstSubmitQcDate': '2021-04-27', 'lastUpdatePostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the concentration-time curve from time 0 to 8 hours (AUC0-8) for ELF, AM, and plasma', 'timeFrame': '8 hours after the start of the third study drug IV infusion'}, {'measure': 'Maximum observed concentration (Cmax) for ELF, AM, and plasma', 'timeFrame': '8 hours after the start of the third study drug IV infusion'}, {'measure': 'Minimum concentration (Cmin) for ELF, AM, and plasma', 'timeFrame': '8 hours after the start of the third study drug IV infusion'}, {'measure': 'Time to the maximum observed concentration (Tmax) for ELF, AM, and plasma', 'timeFrame': '8 hours after the start of the third study drug IV infusion'}], 'secondaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'Day -1 to Day 7', 'description': 'To assess the incidents of treatment-emergent adverse events following three 100mg SPR206 intravenous doses administered every 8 hours. AEs will be classified by System Organ Class (SOC) and Preferred Term (PT). Incidence, frequency, severity and duration will be presented.'}, {'measure': 'Incidence of abnormal vital sign assessments - blood pressure', 'timeFrame': 'Day -1 to Day 7', 'description': 'To assess the incidents of abnormal systolic and diastolic blood pressure assessments following three 100mg SPR206 intravenous doses administered every 8 hours. Frequency count of significant changes from baseline will be presented.'}, {'measure': 'Incidence of abnormal vital sign assessments - body temperature', 'timeFrame': 'Day -1 to Day 7', 'description': 'To assess the incidents of abnormal body temperature assessments following three 100mg SPR206 intravenous doses administered every 8 hours. Frequency count of significant changes from baseline will be presented.'}, {'measure': 'Incidence of abnormal vital sign assessments - heart rate', 'timeFrame': 'Day -1 to Day 7', 'description': 'To assess the incidents of abnormal heart rate assessments following three 100mg SPR206 intravenous doses administered every 8 hours. Frequency count of significant changes from baseline will be presented.'}, {'measure': 'Incidence of abnormal vital sign assessments - respiratory rate', 'timeFrame': 'Day -1 to Day 7', 'description': 'To assess the incidents of abnormal respiratory rate assessments following three 100mg SPR206 intravenous doses administered every 8 hours. Frequency count of significant changes from baseline will be presented.'}, {'measure': 'Incidence of abnormal physical exam assessments', 'timeFrame': 'Day -1 to Day 7', 'description': 'To assess the incidents of abnormal body system assessments following three 100mg SPR206 intravenous doses administered every 8 hours. Changes from baseline in physical examination findings will be classified as Normal, Abnormal NCS, and Abnormal CS. Frequency counts will be presented.'}, {'measure': 'Incidence of abnormal ECG assessments - heart rate', 'timeFrame': 'Day -1 to Day 7', 'description': 'To assess the incidents of abnormal heart rate assessment following three 100mg SPR206 intravenous doses administered every 8 hours. Cardiac (12-Lead ECG) for heart rate will be classified as normal, abnormality that is NCS, and CS abnormality. Frequency counts by dose group and timepoint of collection will be presented.'}, {'measure': 'Incidence of abnormal ECG assessments - PR, RR, QRS, QT and QTcF interval', 'timeFrame': 'Day -1 to Day 7', 'description': 'To assess the incidents of abnormal PR interval, RR interval, QRS interval, QT interval and QTcF interval assessments following three 100mg SPR206 intravenous doses administered every 8 hours. Cardiac (12-Lead ECG) results will be classified as normal, abnormality that is NCS, and CS abnormality. Frequency counts by dose group and timepoint of collection will be presented.'}, {'measure': 'Incidence of abnormal safety laboratory assessments', 'timeFrame': 'Day -1 to Day 7', 'description': 'To assess the incidents of abnormal hematology, serum chemistry, coagulation and urinalysis assessments following three 100mg SPR206 intravenous doses administered every 8 hours. Frequency counts of significant changes from baseline will be presented.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pharmacokinetics', 'alveolar macrophages (AM)', 'epithelial lining fluid (ELF)', 'intrapulmonary', 'bronchoalveolar lavage'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'To evaluate the intrapulmonary pharmacokinetics (PK), including epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations, of SPR206 as well as plasma concentrations of SPR206 in healthy adult volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-smoker for at least 12 months prior to screening for the study\n* BMI ≥ 18.5 and ≤ 32 (kg/m2) and weight between 55.0 and 100.0 kg (both inclusive)\n* Medically healthy without clinically significant abnormalities as assessed by the Investigator based on screening medical history, physical examination, vital signs, 12-lead ECG, hematology, biochemistry, coagulation, and urinalysis\n* Forced expiratory volume in 1 second (FEV1) of at least 80% of predicted value at screening\n* Ability and willingness to abstain from alcohol, caffeine, xanthine-containing beverages or food from 48 hours prior to study drug administration until discharge from the clinical unit\n* If male, must agree to use a condom and have a non-pregnant female partner of childbearing potential agree to use a highly effective method of contraception\n* If female, must be of non-childbearing potential or, if female of childbearing potential, a willingness to abstain from sexual activity or agree to use a high effective method of contraception that could lead to pregnancy\n* Other inclusion criteria per protocol\n\nExclusion Criteria:\n\n* History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, vascular or neurological disease, including any acute illness or surgery within the past 3 months determined by the Investigator to be clinically relevant\n* Recent history (within 6 months) of known or suspected Clostridium difficile infection\n* History of seizure disorders\n* Positive urine drug, alcohol or cotinine testing at screening or check-in (Day -1)\n* Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C antibodies (HCV Ab)\n* Positive testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening or prior to first dosing\n* Presence of the following symptoms at screening or within 28 days prior to screening or check-in (Day -1):\n\n 1. Fever, chills or sweats (temperature of 38 °C / 100.4 °F or higher)\n 2. Difficulty breathing\n 3. Cough\n 4. Sore throat\n 5. New or recent loss of taste or smell\n 6. Nausea, vomiting or diarrhea\n* Close contact with anyone who tested positive for SARS-CoV-2 infection within 28 days prior to screening or check-in (Day -1)\n* Electrocardiogram (ECG) with QTcF interval duration equal or greater than 450 msec for males and 470 msec for females\n* Subjects who have any of the following abnormalities on laboratory values at screening or Check-In including:\n\n 1. White blood cell count \\< 3,000/mm3, hemoglobin \\< 11g/dL\n 2. Absolute neutrophil count ≤ 2,000/mm3, platelet count \\<120,000/mm3\n 3. alanine aminotransferase (ALT) OR aspartate aminotransferase (AST) greater than the upper limit of normal (ULN) for the reference laboratory\n* History of substance abuse or alcohol abuse\n* Use of prescription medicine \\& tobacco/nicotine or marijuana-containing products\n* A female who is pregnant or breastfeeding\n* Other exclusion criteria per protocol'}, 'identificationModule': {'nctId': 'NCT04868292', 'briefTitle': 'Study to Assess the Intrapulmonary Pharmacokinetics of SPR206 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Spero Therapeutics'}, 'officialTitle': 'A Phase 1, Single-Center, Open-Label Study to Assess the Intrapulmonary Pharmacokinetics of SPR206 by Comparing the Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations Following the Intravenous Administration of SPR206 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'SPR206-102'}, 'secondaryIdInfos': [{'id': 'CDMRP-JW180095-A', 'type': 'OTHER_GRANT', 'domain': 'United States Department of Defense'}, {'id': '2020-006019-52', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SPR206', 'description': 'Healthy subjects meeting eligibility criteria will receive a total of three 100 mg SPR206 intravenous doses administered every 8 hours.', 'interventionNames': ['Drug: SPR206']}], 'interventions': [{'name': 'SPR206', 'type': 'DRUG', 'description': 'Three 100 mg SPR206 intravenous doses administered every 8 hours', 'armGroupLabels': ['SPR206']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M23 9QZ', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Medical Facility', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'David Melnick, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Spero Therapeutics Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spero Therapeutics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}