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A Study to Evaluate Plasma Gelsolin in Healthy Volunteers

NCT05789745 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-09-19

Study results available
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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.

Conditions

  • Volunteers
  • Healthy

Interventions

DRUG

Recombinant human plasma gelsolin

intravenous administration of either 6, 12, 18, or 24 mg/kg at time 0, 12, 36, 60 and 84 hours

OTHER

placebo

intravenous administration of saline control at time 0, 12, 36, 60 and 84 hours

Sponsors & Collaborators

  • BioAegis Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Mark J DiNubile, MD · BioAegis Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-14
Primary Completion
2023-05-24
Completion
2023-05-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05789745 on ClinicalTrials.gov