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

ConditionHealthy
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age19-55
Sponsor1ST Biotherapeutics, Inc.

About this trial

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)).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • FB-101

    Drug

    FB-101 10mg

  • Placebo for FB-101

    Drug

    Placebo for FB-101

Treatment groups

72 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: SAD 1. FB-101 10mgExperimental treatment 2 interventions
Group B: SAD 2. FB-101 20mgExperimental treatment 2 interventions
Group C: SAD 3. FB-101 40mgExperimental treatment 2 interventions
Group D: MAD 4. FB-101 10mg QDExperimental treatment 2 interventions
Group E: MAD 5. FB-101 20mg QDExperimental treatment 2 interventions
Group F: MAD 6. FB-101 30mg QDExperimental treatment 2 interventions
Group G: MAD 7. FB-101 10mg BIDExperimental treatment 2 interventions
Group H: MAD 8. FB-101 20mg BIDExperimental treatment 2 interventions
Group I: MAD 9. FB-101 30mg BIDExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
up to 2 month

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

1ST Biotherapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: