Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-02 @ 12:05 AM
Study NCT ID:
NCT07126704
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-17
First Post:
2025-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1, SAD and MAD to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral FB-101 in Healthy Adult Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2025-08-11', 'studyFirstSubmitQcDate': '2025-08-11', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and severity of TEAEs', 'timeFrame': 'up to 2 month', 'description': 'Number and severity of TEAEs following single ascending oral doses of FB-101 compared to placebo in healthy adult male subjects.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, randomized, double-blind, placebo-controlled study consisting of SAD and MAD investigation at a single clinical trial center conducted in healthy adult male subjects assessing the safety, tolerability, PK, and PD of oral FB-101 administration.\n\nUp to 72 healthy adult male subjects will be enrolled. Additional subjects may be enrolled (8 subjects per cohort) if it is deemed appropriate following review (e.g., in the circumstances where a dose level is repeated, or an intermediate dose is conducted or to add another dose level(s) (higher than those planned)).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Healthy, adult, male 19-55 years of age, inclusive, at screening.\n2. A continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to (the first) dosing and throughout the study, based on subject self-reporting.\n3. Body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 at screening.\n4. Medically healthy with no clinically significant medical history, physical examination, neurological examination, ophthalmic examination, clinical laboratory profiles, vital signs, or safety 12-lead ECGs, as deemed by the PI or designee.\n5. A non-vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days after (the last) dosing. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to (the first) dosing of the investigational product. A male who has been vasectomized less than 4 months prior to study (first) dosing must follow the same restrictions as a non-vasectomized male).\n6. Must agree not to donate sperm from the first dosing until 90 days after the last dosing.\n7. Able to swallow multiple capsules.\n\nKey Exclusion Criteria:\n\n1. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.\n2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.\n3. Is at suicidal risk in the opinion of the PI or designee.\n4. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or pose an additional risk to the subject by their participation in the study.'}, 'identificationModule': {'nctId': 'NCT07126704', 'briefTitle': 'A Phase 1, SAD and MAD to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral FB-101 in Healthy Adult Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': '1ST Biotherapeutics, Inc.'}, 'officialTitle': 'A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral FB-101 in Healthy Adult Male Subjects', 'orgStudyIdInfo': {'id': 'FB101_P102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SAD 1. FB-101 10mg', 'interventionNames': ['Drug: FB-101', 'Drug: Placebo for FB-101']}, {'type': 'EXPERIMENTAL', 'label': 'SAD 2. FB-101 20mg', 'interventionNames': ['Drug: FB-101', 'Drug: Placebo for FB-101']}, {'type': 'EXPERIMENTAL', 'label': 'SAD 3. FB-101 40mg', 'interventionNames': ['Drug: FB-101', 'Drug: Placebo for FB-101']}, {'type': 'EXPERIMENTAL', 'label': 'MAD 4. FB-101 10mg QD', 'interventionNames': ['Drug: FB-101', 'Drug: Placebo for FB-101']}, {'type': 'EXPERIMENTAL', 'label': 'MAD 5. FB-101 20mg QD', 'interventionNames': ['Drug: FB-101', 'Drug: Placebo for FB-101']}, {'type': 'EXPERIMENTAL', 'label': 'MAD 6. FB-101 30mg QD', 'interventionNames': ['Drug: FB-101', 'Drug: Placebo for FB-101']}, {'type': 'EXPERIMENTAL', 'label': 'MAD 7. FB-101 10mg BID', 'interventionNames': ['Drug: FB-101', 'Drug: Placebo for FB-101']}, {'type': 'EXPERIMENTAL', 'label': 'MAD 8. FB-101 20mg BID', 'interventionNames': ['Drug: FB-101', 'Drug: Placebo for FB-101']}, {'type': 'EXPERIMENTAL', 'label': 'MAD 9. FB-101 30mg BID', 'interventionNames': ['Drug: FB-101', 'Drug: Placebo for FB-101']}], 'interventions': [{'name': 'FB-101', 'type': 'DRUG', 'description': 'FB-101 10mg', 'armGroupLabels': ['MAD 4. FB-101 10mg QD', 'MAD 5. FB-101 20mg QD', 'MAD 6. FB-101 30mg QD', 'MAD 7. FB-101 10mg BID', 'MAD 8. FB-101 20mg BID', 'MAD 9. FB-101 30mg BID', 'SAD 1. FB-101 10mg', 'SAD 2. FB-101 20mg', 'SAD 3. FB-101 40mg']}, {'name': 'Placebo for FB-101', 'type': 'DRUG', 'description': 'Placebo for FB-101', 'armGroupLabels': ['MAD 4. FB-101 10mg QD', 'MAD 5. FB-101 20mg QD', 'MAD 6. FB-101 30mg QD', 'MAD 7. FB-101 10mg BID', 'MAD 8. FB-101 20mg BID', 'MAD 9. FB-101 30mg BID', 'SAD 1. FB-101 10mg', 'SAD 2. FB-101 20mg', 'SAD 3. FB-101 40mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'In Jin Jang, M.D. Ph.D', 'role': 'CONTACT', 'email': 'ijjang@snu.ac.kr'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'In Jin Jang, MD, Ph.D.', 'role': 'CONTACT', 'email': 'ijjang@snu.ac.kr', 'phone': '+8227408290'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '1ST Biotherapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}