Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2026-01-01 @ 6:10 PM
Study NCT ID:
NCT03559166
Status:
COMPLETED
Last Update Posted:
2020-03-19
First Post:
2018-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First in Human Study in Healthy Volunteers Followed With Dosing in Participants With Lung or Liver Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Randomized, double-blind, placebo controlled'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-17', 'studyFirstSubmitDate': '2018-04-24', 'studyFirstSubmitQcDate': '2018-06-05', 'lastUpdatePostDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events (AEs)', 'timeFrame': '2 weeks', 'description': 'AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events'}, {'measure': 'Any observed changes in clinical safety laboratory results', 'timeFrame': '2 weeks', 'description': 'Assessed by reviewing any observed changes in CBC, serum chemistry or urinalysis from baseline by dose. Results in subjects dosed with BLD-2660 treatment will be compared to those dosed with placebo.'}, {'measure': 'Any observed changes in physical examinations', 'timeFrame': '2 weeks', 'description': 'Assessed by reviewing any observed changes in physical examinations from baseline by dose. Results in subjects dosed with BLD-2660 will be compared to those dosed with placebo.'}, {'measure': 'Any observed changes in vital signs', 'timeFrame': '2 weeks', 'description': 'Assessed by reviewing any observed changes in vital signs from baseline by dose. Results in subjects dosed with BLD-2660 will be compared to those dosed with placebo.'}, {'measure': 'Any observed changes in ECG', 'timeFrame': '2 weeks', 'description': 'Assessed by reviewing any observed changes in ECG from baseline by dose. Results in subjects dosed with BLD-2660 will be compared to those dosed with placebo.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fibrosis']}, 'descriptionModule': {'briefSummary': 'First in Human single ascending dose followed by multiple ascending doses in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to provide written informed consent\n* Agree to no smoking or alcohol or illegal substance 48 hours prior to dosing\n* Have a negative urine drug screen/alcohol breath test on admission to clinic\n* Agree to use highly effective, double barrier contraception (both male and female partners) during the study and for 30 days following completion of dosing\n* Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1\n* Normal BMI except liver fibrosis participants (BMI 18 to ≤35 kg/m2)\n* Be in general good health\n* Clinical laboratory values within normal range\n* Lung fibrosis participants-a diagnosis of lung fibrosis,\n* Liver fibrosis participants-a diagnosis of liver fibrosis; some abnormal laboratory values will be acceptable for the following; platelet count, albumin, serum creatinine and neutrophil-leukocyte ration\n\nExclusion Criteria:\n\n* Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the subject will complete the study per protocol\n* History or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration, and unwillingness to be totally abstinent during the dosing period\n* Blood donation or significant blood loss within 60 days prior to the first study drug administration\n* Plasma donation within 7 days prior to the first study drug administration\n* Administration of investigational product (IP) in another trial within 30 days prior to the first study drug administration, or five half-lives, whichever is longer\n* Females who are pregnant or lactating\n* Surgery within the past 3 months prior to the first study drug administration determined by the PI to be clinically relevant\n* Failure to satisfy the PI of fitness to participate for any other reason\n* Active infection or history of recurrent infections\n* Active malignancy and history of malignancy in the past 5 years, with the exception of completely excised basal cell carcinoma or low grade cervical intraepithelial neoplasia\n* Chronic obstructive pulmonary disease\n* Antibiotic treatment within 3 months\n* Chronic medical condition'}, 'identificationModule': {'nctId': 'NCT03559166', 'briefTitle': 'First in Human Study in Healthy Volunteers Followed With Dosing in Participants With Lung or Liver Fibrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Blade Therapeutics'}, 'officialTitle': 'A Phase Ia/Ib, Randomized, Double Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BLD-2660 in Healthy Volunteers and Patients With Lung Fibrosis or Liver Fibrosis', 'orgStudyIdInfo': {'id': 'B-2660-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cohort 1a - starting dose', 'description': 'Single oral dose of BLD-2660 or placebo capsule administered to healthy volunteers', 'interventionNames': ['Drug: BLD-2660']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'cohort 1b- first SAD escalation', 'description': 'Single oral dose of BLD-2660 or placebo capsule(s) administered to healthy volunteers (1st dose escalation)', 'interventionNames': ['Drug: BLD-2660']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'cohort 1c-2nd SAD escalation', 'description': 'Single oral dose of BLD-2660 or placebo capsule(s) administered to healthy volunteers (2nd dose escalation) in fasting state, followed by washout period and then single oral dose of BLD-2660 or placebo administered to healthy volunteers in fed state.', 'interventionNames': ['Drug: BLD-2660']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'cohort 1d-3rd SAD escalation', 'description': 'Single oral dose of BLD-2660 or placebo capsules(s) administered to healthy volunteers (3rd dose escalation)', 'interventionNames': ['Drug: BLD-2660']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'cohort 1e-4th SAD escalation', 'description': 'Single oral dose of BLD-2660 or placebo capsule(s) administered to healthy volunteers (final dose escalation if assessed as safe).', 'interventionNames': ['Drug: BLD-2660']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'cohort 2a-1st MAD cohort', 'description': 'Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers', 'interventionNames': ['Drug: BLD-2660']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'cohort 2b-2nd MAD escalation', 'description': 'Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.', 'interventionNames': ['Drug: BLD-2660']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'cohort 2c-3rd MAD escalation', 'description': 'Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.', 'interventionNames': ['Drug: BLD-2660']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'cohort 2d-4th MAD escalation', 'description': 'Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.', 'interventionNames': ['Drug: BLD-2660']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'cohort 2e-5th MAD escalation', 'description': 'Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.', 'interventionNames': ['Drug: BLD-2660']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'cohort 2F-6th MAD escalation', 'description': 'Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.', 'interventionNames': ['Drug: BLD-2660']}], 'interventions': [{'name': 'BLD-2660', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Randomized to active product or placebo', 'armGroupLabels': ['cohort 1a - starting dose', 'cohort 1b- first SAD escalation', 'cohort 1c-2nd SAD escalation', 'cohort 1d-3rd SAD escalation', 'cohort 1e-4th SAD escalation', 'cohort 2F-6th MAD escalation', 'cohort 2a-1st MAD cohort', 'cohort 2b-2nd MAD escalation', 'cohort 2c-3rd MAD escalation', 'cohort 2d-4th MAD escalation', 'cohort 2e-5th MAD escalation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Nucleus Network', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Ben Snyder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nucleus Network'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Blade Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}