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NCT04165837 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Pharmacokinetics of Oral FB-101 in Healthy Subjects
A Phase 1 study, sponsored by 1ST Biotherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT04165837: Completed Phase 1 study, sponsored by 1ST Biotherapeutics.
NCT04165837 is a Phase 1 study that has completed, run by 1ST Biotherapeutics. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04165837, a Phase 1 study, has completed, sponsored by 1ST Biotherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of oral doses of FB-101 in healthy subjects.
Primary Outcome
To assess the safety and tolerability of single and multiple ascending oral doses of FB-101 in healthy adult subjects
Interventions
- DRUG Placebo
- DRUG FB-101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2019-10-14 |
| Est. Completion | 2022-07-14 |
| Phase | Phase 1 |
What the finished NCT04165837 record still lists
NCT04165837 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04165837 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04165837 about?
NCT04165837 is a clinical study titled "Safety, Tolerability, and Pharmacokinetics of Oral FB-101 in Healthy Subjects". The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of oral doses of FB-101 in healthy subjects.
What is the current status of trial NCT04165837?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2019-10-14. Estimated completion is 2022-07-14.
What interventions are being tested in trial NCT04165837?
The interventions under investigation include: Placebo (DRUG), FB-101 (DRUG).
Who is sponsoring clinical trial NCT04165837?
This trial is sponsored by 1ST Biotherapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04165837's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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