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Q4W GMA301 IV injections (300 mg) for Pulmonary Arterial Hypertension

Phase 1
Waitlist Available
Led By Jimmy Shaun Smith
Research Sponsored by Gmax Biopharm LLC.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (up to 22 weeks)
Awards & highlights

Study Summary

This trial is testing a new drug to see if it's safe and effective for treating pulmonary arterial hypertension.

Eligible Conditions
  • Pulmonary Arterial Hypertension

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (up to 22 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (up to 22 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The incidence of Treatment-emergent Adverse Events (TEAE) in subjects assigned to GMA301 compared with those assigned to placebo.
Secondary outcome measures
Comparing 6MWT distance
Comparison of GMA301 treatment effect at Week 12 versus baseline regarding the pulmonary vascular resistance (PVR) based on right heart catheterization (RHC)
Pharmacokinetics (Area under the serum concentration- time curve from time zero to the last measurable concentration)
Other outcome measures
Changes in REVEAL 2.0 risk score at Week 12 compared with baseline

Trial Design

4Treatment groups
Experimental Treatment
Group I: Q4W GMA301 IV injections (600 mg)Experimental Treatment2 Interventions
Drug: Q4W GMA301 IV injections (600 mg) Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo. Other: Q4W placebo IV injections Placebo is indistinguishable from GMA301
Group II: Q4W GMA301 IV injections (300 mg)Experimental Treatment2 Interventions
Drug: Q4W GMA301 IV injections (300 mg) Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo. Other: Q4W placebo IV injections Placebo is indistinguishable from GMA301
Group III: Q4W GMA301 IV injections (1800 mg)Experimental Treatment2 Interventions
Drug: Q4W GMA301 IV injections (1800 mg) Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo. Other: Q4W placebo IV injections Placebo is indistinguishable from GMA301
Group IV: Q4W GMA301 IV injections (1000 mg)Experimental Treatment2 Interventions
Drug: Q4W GMA301 IV injections (1000 mg) Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo. Other: Q4W placebo IV injections Placebo is indistinguishable from GMA301

Find a Location

Who is running the clinical trial?

Gmax Biopharm LLC.Lead Sponsor
Jimmy Shaun SmithPrincipal InvestigatorThe Ohio State University - Dorothy M. Davis Heart and Lung Research Institute
Kelly ChinPrincipal InvestigatorUniversity of Texas Southwestern Medical Center
~10 spots leftby Jun 2025
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