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NCT05789745 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Plasma Gelsolin in Healthy Volunteers
A Phase 1 study, sponsored by BioAegis Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT05789745: Completed Phase 1 study, sponsored by BioAegis Therapeutics.
NCT05789745 is a Phase 1 study that has completed, run by BioAegis Therapeutics. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05789745, a Phase 1 study, has completed, sponsored by BioAegis Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
Study BTI-101 is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation, parallel design study to evaluate the safety, tolerability, and pharmacokinetics of IV rhu-pGSN or saline placebo administered as 5 doses each of 6, 12, 18, or 24 mg/kg of body weight. Each of 4 dosing cohorts will include 8 subjects randomized 3:1 rhu-pGSN:placebo (6 rhu-pGSN subjects:2 placebo subjects). Subjects will be healthy adult volunteers 18-55 years of age.
Primary Outcome
Number of subjects who had an Adverse Event
Interventions
- OTHER placebo
- DRUG Recombinant human plasma gelsolin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2023-03-14 |
| Est. Completion | 2023-05-24 |
| Phase | Phase 1 |
What the finished NCT05789745 record still lists
NCT05789745 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT05789745 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05789745 about?
NCT05789745 is a clinical study titled "A Study to Evaluate Plasma Gelsolin in Healthy Volunteers". Study BTI-101 is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation, parallel design study to evaluate the safety, tolerability, and pharmacokinetics of IV rhu-pGSN or saline placebo administered as 5 doses each of 6, 12, 18, or 24 mg/kg of body weight. Each of 4 dosing cohorts...
What is the current status of trial NCT05789745?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2023-03-14. Estimated completion is 2023-05-24.
What interventions are being tested in trial NCT05789745?
The interventions under investigation include: placebo (OTHER), Recombinant human plasma gelsolin (DRUG).
Who is sponsoring clinical trial NCT05789745?
This trial is sponsored by BioAegis Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05789745's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 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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