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Anti-inflammatory Protein

Rhu-pGSN for Acute Respiratory Distress Syndrome

Phase 2
Recruiting
Research Sponsored by BioAegis Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male subjects with a partner who might become pregnant must agree to use reliable forms of contraception (i.e., vasectomy, abstinence), or an acceptable method of birth control must be used by the partner
Female subjects of childbearing potential must agree to use 2 medically accepted/FDA-approved birth control methods
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 days

Summary

This trial aims to test the effectiveness and safety of a new treatment called rhu-pGSN when added to standard care for patients with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS

Who is the study for?
This trial is for adults over 18 with moderate-to-severe ARDS due to pneumonia or other infections, who are on mechanical ventilation or receiving high-flow oxygen. They must have had acute lung failure within the past 48 hours and show specific signs on chest imaging. Women of childbearing age and men with partners at risk of pregnancy must use reliable contraception.
What is being tested?
The study tests rhu-pGSN, a potential new treatment for ARDS, against a saline placebo. Both groups receive standard care as well. Participants are randomly assigned to either the test drug or placebo without knowing which one they're getting (double-blind).
What are the potential side effects?
While specific side effects aren't listed here, participants should be aware that any new medication can cause unexpected reactions ranging from mild symptoms like headaches or nausea to more serious conditions affecting organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am using or my partner is using effective birth control.
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I agree to use two approved methods of birth control.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
All-cause mortality at day 28
Secondary study objectives
All-cause mortality at day 60
Days in the ICU and in the hospital
Frequency of RRT
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Rhu-pGSN TreatmentExperimental Treatment1 Intervention
Subjects will receive rhu-pGSN 24 mg/kg once, followed by 5 daily doses of 12 mg/kg based on actual body weight in addition to standard care .
Group II: Normal Saline PlaceboPlacebo Group1 Intervention
Subjects will receive 6 doses of normal-saline placebo in volumes equivalent to subjects given rhu-pGSN in addition to standard care.

Find a Location

Who is running the clinical trial?

Biomedical Advanced Research and Development AuthorityFED
97 Previous Clinical Trials
563,645 Total Patients Enrolled
BioAegis Therapeutics Inc.Lead Sponsor
4 Previous Clinical Trials
165 Total Patients Enrolled
~400 spots leftby Oct 2026
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