A Phase 1, SAD and MAD to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral FB-101 in Healthy Adult Male Subjects
NCT ID: NCT07126704
Last Updated: 2025-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
72 participants
INTERVENTIONAL
2025-11-30
2027-06-30
Brief Summary
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Up 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)).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SAD 1. FB-101 10mg
FB-101
FB-101 10mg
Placebo for FB-101
Placebo for FB-101
SAD 2. FB-101 20mg
FB-101
FB-101 10mg
Placebo for FB-101
Placebo for FB-101
SAD 3. FB-101 40mg
FB-101
FB-101 10mg
Placebo for FB-101
Placebo for FB-101
MAD 4. FB-101 10mg QD
FB-101
FB-101 10mg
Placebo for FB-101
Placebo for FB-101
MAD 5. FB-101 20mg QD
FB-101
FB-101 10mg
Placebo for FB-101
Placebo for FB-101
MAD 6. FB-101 30mg QD
FB-101
FB-101 10mg
Placebo for FB-101
Placebo for FB-101
MAD 7. FB-101 10mg BID
FB-101
FB-101 10mg
Placebo for FB-101
Placebo for FB-101
MAD 8. FB-101 20mg BID
FB-101
FB-101 10mg
Placebo for FB-101
Placebo for FB-101
MAD 9. FB-101 30mg BID
FB-101
FB-101 10mg
Placebo for FB-101
Placebo for FB-101
Interventions
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FB-101
FB-101 10mg
Placebo for FB-101
Placebo for FB-101
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 at screening.
4. 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.
5. 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).
6. Must agree not to donate sperm from the first dosing until 90 days after the last dosing.
7. Able to swallow multiple capsules.
Exclusion Criteria
2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
3. Is at suicidal risk in the opinion of the PI or designee.
4. 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.
19 Years
55 Years
MALE
Yes
Sponsors
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1ST Biotherapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FB101_P102
Identifier Type: -
Identifier Source: org_study_id
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