A Phase 1, SAD and MAD to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral FB-101 in Healthy Adult Male Subjects

Launched by 1ST BIOTHERAPEUTICS, INC. · Aug 11, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new oral medicine called FB-101 to see if it is safe and well-tolerated in healthy adult men. The study is in its early phase (Phase 1), where researchers want to understand how the body processes the medicine and how it affects the body. The study will include up to 72 healthy men who meet specific health and lifestyle requirements, such as being between 19 and 55 years old, non-smokers, and having a normal body weight.

If you join this study, you can expect to take the medicine or a placebo (a harmless pill with no medicine) while doctors monitor your health closely. This includes regular check-ups, tests, and following rules about sexual activity and sperm donation during and after the study. The goal is to make sure the medicine is safe before it is tested in people with health conditions. This study is not yet recruiting participants but will take place at one clinical center.

Gender

MALE

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Healthy, adult, male 19-55 years of age, inclusive, at screening.
• • 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.
• Key Exclusion Criteria:
• • 1. 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.
• • 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.