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 baseline to week 12

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Other study objectives

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

Do I qualify?Apply below to find out