A Randomized, Double-blind, Placebo-Controlled, Dose Escalation Study to Assess Safety, Efficacy and Pharmacokinetics of GMA301 in Subjects With Pulmonary Arterial Hypertension
Overview
- Phase
- Phase 1
- Intervention
- Q4W placebo IV injections
- Conditions
- Pulmonary Arterial Hypertension
- Sponsor
- Gmax Biopharm LLC.
- Enrollment
- 48
- Locations
- 7
- Primary Endpoint
- The incidence of Treatment-emergent Adverse Events (TEAE) in subjects assigned to GMA301 compared with those assigned to placebo.
- Last Updated
- 4 years ago
Overview
Brief Summary
A Randomized, Placebo-Controlled, Double-blind, Dose Escalation Study to Assess Safety, Efficacy and Pharmacokinetics of GMA301 Injection in Subjects with Pulmonary Arterial Hypertension
Detailed Description
Drug: Q4W GMA301 IV injections (300 mg) Drug: Q4W GMA301 IV injections (600 mg) Drug: Q4W GMA301 IV injections (1000 mg) Drug: Q4W GMA301 IV injections (1800 mg) Other: Q4W placebo IV injections
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Q4W GMA301 IV injections (600 mg)
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
Intervention: Q4W placebo IV injections
Q4W GMA301 IV injections (300 mg)
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
Intervention: Q4W GMA301 IV injections (300 mg)
Q4W GMA301 IV injections (300 mg)
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
Intervention: Q4W placebo IV injections
Q4W GMA301 IV injections (600 mg)
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
Intervention: Q4W GMA301 IV injections (600 mg)
Q4W GMA301 IV injections (1000 mg)
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
Intervention: Q4W GMA301 IV injections (1000 mg)
Q4W GMA301 IV injections (1000 mg)
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
Intervention: Q4W placebo IV injections
Q4W GMA301 IV injections (1800 mg)
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
Intervention: Q4W GMA301 IV injections (1800 mg)
Q4W GMA301 IV injections (1800 mg)
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
Intervention: Q4W placebo IV injections
Outcomes
Primary Outcomes
The incidence of Treatment-emergent Adverse Events (TEAE) in subjects assigned to GMA301 compared with those assigned to placebo.
Time Frame: Through study completion (up to 22 weeks)
Secondary Outcomes
- Pharmacokinetics (Area under the serum concentration- time curve from time zero to the last measurable concentration)(Through study completion (up to 22 weeks))
- Comparison of GMA301 treatment effect at Week 12 versus baseline regarding the pulmonary vascular resistance (PVR) based on right heart catheterization (RHC)(Baseline to Week 12)
- Comparing 6MWT distance(Baseline to Week 12)