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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 is a Phase 1 study that has completed, run by BioAegis Therapeutics. The registered enrollment target is 32 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05789745
The ClinicalTrials.gov registry entry for NCT05789745 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioAegis Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT05789745 reports 0 study locations.
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.
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