A Study of GMA301 in Subjects With Pulmonary Arterial Hypertension

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

Conditions

• Pulmonary Arterial Hypertension

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.

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.

Sponsors & Collaborators

• Gmax Biopharm LLC.

  lead INDUSTRY

Principal Investigators

• Hua Yao · Guangdong Provincial People's Hospital

• Lan Wang · Shanghai Pulmonary Hospital, Shanghai, China

• Wei Huang · First Affiliated Hospital of Chongqing Medical University

• Zaixin Yu · Xiangya Hospital of Central South University

• Fenling Fan · First Affiliated Hospital Xi'an Jiaotong University

• Zhicheng Jing · Peking Union Medical College Hospital - Dongcheng District

• Aaron Waxman · Brigham and Women's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-22

Primary Completion

2022-10-26

Completion

2023-06-10

FDA Drug

Yes

Countries

• United States
• China

Study Locations