A Study of GMA301 in Subjects With Pulmonary Arterial Hypertension

Phase 1

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Drug: Q4W GMA301 IV injections (1800 mg); Drug: Q4W GMA301 IV injections (300 mg); Drug: Q4W GMA301 IV injections (600 mg); Drug: Q4W GMA301 IV injections (1000 mg); Other: Q4W placebo IV injections

• Registration Number: NCT04503733
• Lead Sponsor: Gmax Biopharm LLC.

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

Study Timeline

• Study First Submitted: 2020-07-24
• Study First Submitted QC: 2020-08-05
• Study First Posted: 2020-08-07
• Study Start: 2020-10-22
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-29
• Last Update Posted: 2022-01-14
• Primary Completion: 2022-10-26
• Study Completion: 2023-06-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Q4W GMA301 IV injections (1000 mg)	Q4W placebo IV injections	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
Q4W GMA301 IV injections (600 mg)	Q4W placebo IV injections	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
Q4W GMA301 IV injections (300 mg)	Q4W placebo IV injections	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
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
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
Q4W GMA301 IV injections (600 mg)	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
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
Q4W GMA301 IV injections (1800 mg)	Q4W placebo IV injections	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

Primary Outcome Measures

Name	Time	Method
The incidence of Treatment-emergent Adverse Events (TEAE) in subjects assigned to GMA301 compared with those assigned to placebo.	Through study completion (up to 22 weeks)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, China

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, China

Guangdong General Hospital; 🇨🇳 Guangzhou, China

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

The First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xian, China

Xiangya Hospital, Central South University; 🇨🇳 Changsha, China

Peking Union Medical College Hospital - Dongcheng District; 🇨🇳 Beijing, China