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Plasma Gelsolin

rhu-pGSN for Volunteers

Phase 1

Waitlist Available

Research Sponsored by BioAegis Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 108 hours

Awards & highlights

Study Summary

This trial will test the safety, tolerability and how a drug affects the body in healthy adult volunteers, ages 18-55, in a randomized, double-blind, placebo-controlled study.

Eligible Conditions

Volunteers
Healthy Subjects

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 108 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~108 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 108 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety -- SAE frequency

Safety -- severe AE frequency

Secondary outcome measures

antidrug antibodies -- frequency before and 28 days post-dose

pharmacokinetics -- pGSN levels over time after dosing

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: rhu-pGSNExperimental Treatment1 Intervention

Treated with 5 doses of rhu-pGSN

Group II: normal salinePlacebo Group1 Intervention

Treated with 5 doses of saline

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Recombinant human plasma gelsolin

2023

Completed Phase 1

~40

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

BioAegis Therapeutics Inc.Lead Sponsor

4 Previous Clinical Trials

733 Total Patients Enrolled

Mark J DiNubile, MDStudy DirectorBioAegis Therapeutics

2 Previous Clinical Trials

97 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are my characteristics compliant with the criteria to join this experiment?

"In order to be considered for the clinical trial, eligible participants must have a sound medical history and fall between 18-55 years of age. There is currently space available at this time for 32 individuals."

Answered by AI

How many participants are being accepted for this research endeavor?

"Affirmative. Per the information on clinicaltrials.gov, this research study is presently recruiting patients. First posted on March 14th 2023 and last edited on the 16th of that same month, it requires 32 participants from a single medical centre to take part in its protocol."

Answered by AI

Does this scientific experiment accept elderly individuals as participants?

"As indicated by the study's inclusion criteria, participants must fall between 18 and 55 years of age to be admitted."

Answered by AI

Has the Food and Drug Administration granted clearance to rhu-pGSN?

"Due to the limited evidence of safety and efficacy, rhu-pGSN received a score of 1 on our team's scale. This is due to this being an early phase clinical trial."

Answered by AI

Are there currently opportunities to join this research program?

"Affirmative. On clinicaltrials.gov, it is confirmed that the trial first published on March 14th 2023 is actively recruiting participants; 32 individuals are required from a single research centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate Plasma Gelsolin in Healthy Volunteers

2023. "A Study to Evaluate Plasma Gelsolin in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05789745.