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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.

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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

FieldValue
Enrollment Target 32 participants
Start Date 2023-03-14
Est. Completion 2023-05-24
Phase Phase 1

Sponsor

BioAegis Therapeutics

3 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.