A Phase 1, SAD and MAD to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral FB-101 in Healthy Adult Male Subjects
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
1 other identifier
interventional
72
1 country
1
Brief Summary
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. 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)).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Nov 2025
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2025
CompletedFirst Posted
Study publicly available on registry
August 17, 2025
CompletedStudy Start
First participant enrolled
November 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
August 17, 2025
August 1, 2025
7 months
August 11, 2025
August 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Number and severity of TEAEs
Number and severity of TEAEs following single ascending oral doses of FB-101 compared to placebo in healthy adult male subjects.
up to 2 month
Study Arms (9)
SAD 1. FB-101 10mg
EXPERIMENTALSAD 2. FB-101 20mg
EXPERIMENTALSAD 3. FB-101 40mg
EXPERIMENTALMAD 4. FB-101 10mg QD
EXPERIMENTALMAD 5. FB-101 20mg QD
EXPERIMENTALMAD 6. FB-101 30mg QD
EXPERIMENTALMAD 7. FB-101 10mg BID
EXPERIMENTALMAD 8. FB-101 20mg BID
EXPERIMENTALMAD 9. FB-101 30mg BID
EXPERIMENTALInterventions
FB-101 10mg
Placebo for FB-101
Eligibility Criteria
You may qualify if:
- Healthy, adult, male 19-55 years of age, inclusive, at screening.
- 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.
- Body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 at screening.
- 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.
- 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).
- Must agree not to donate sperm from the first dosing until 90 days after the last dosing.
- Able to swallow multiple capsules.
You may not qualify if:
- 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.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- Is at suicidal risk in the opinion of the PI or designee.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 03080, South Korea
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2025
First Posted
August 17, 2025
Study Start
November 1, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2027
Last Updated
August 17, 2025
Record last verified: 2025-08