NCT04503733

A Study of GMA301 in Subjects With Pulmonary Arterial Hypertension

A Randomized, Double-blind, Placebo-Controlled, Dose Escalation Study to Assess Safety, Efficacy and Pharmacokinetics of GMA301 in Subjects With Pulmonary Arterial Hypertension

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Gmax Biopharm LLC. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
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.
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.
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.
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.

Timeline

• Start date: 2020-10-22
• Primary completion: 2022-10-26
• Completion: 2023-06-10
• First posted: 2020-08-07
• Last updated: 2022-01-14

Locations

7 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study