A Study of GMA301 in Subjects With Pulmonary Arterial Hypertension

NCT04503733 | Unknown Phase 1 FDA Drug

• 1 other identifier: GETA_MAD_01
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 7

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

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Other Outcomes (1)

• Changes in REVEAL 2.0 risk score at Week 12 compared with baseline

  Baseline to Week 12

Study Arms (4)

Q4W GMA301 IV injections (300 mg)

EXPERIMENTAL

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

Drug: Q4W GMA301 IV injections (300 mg); Other: Q4W placebo IV injections

Q4W GMA301 IV injections (600 mg)

EXPERIMENTAL

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

Drug: Q4W GMA301 IV injections (600 mg); Other: Q4W placebo IV injections

Q4W GMA301 IV injections (1000 mg)

EXPERIMENTAL

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

Drug: Q4W GMA301 IV injections (1000 mg); Other: Q4W placebo IV injections

Q4W GMA301 IV injections (1800 mg)

EXPERIMENTAL

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

Drug: Q4W GMA301 IV injections (1800 mg); Other: Q4W placebo IV injections

Interventions

Q4W GMA301 IV injections (300 mg) DRUG

Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.

Q4W GMA301 IV injections (300 mg)

Q4W GMA301 IV injections (600 mg) DRUG

Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.

Q4W GMA301 IV injections (600 mg)

Q4W GMA301 IV injections (1000 mg) DRUG

Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.

Q4W GMA301 IV injections (1000 mg)

Q4W GMA301 IV injections (1800 mg) DRUG

Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.

Q4W GMA301 IV injections (1800 mg)

Q4W placebo IV injections OTHER

Placebo is indistinguishable from GMA301.

Q4W GMA301 IV injections (1000 mg); Q4W GMA301 IV injections (1800 mg); Q4W GMA301 IV injections (300 mg); Q4W GMA301 IV injections (600 mg)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all of the following criteria:
• Male or female, aged 18 to 75 years inclusive
• WHO Group 1 PAH related to one of the following conditions:
• Idiopathic
• Heritable
• Drugs or toxins-induced
• Associated with connective tissue disease
• Associated with congenital heart disease if subjects underwent surgical correction more than 12 months before Screening
• Symptoms due to PAH are consistent with WHO functional class II- III
• Have not taken endothelin receptor antagonists (ERAs) within 3 months before Randomization
• Has been taking at least one oral PAH targeted drug that has been approved by local guidelines for at least 3 months before Screening with stable dosage and the disease did not worsen during this period per Investigator's judgment
• Right heart catheterization (RHC) result meets below criteria when Screening:
• Mean pulmonary arterial pressure (PAP) ≥25 mmHg
• Pulmonary vascular resistance (PVR) \>3 Woods units
• PA wedge pressure (PAWP) ≤15 mmHg

You may not qualify if:

• Subjects who me et any of the following criteria will not be allowed to participate in this study:
• Diagnosed with WHO Group II, III, IV, V of PH
• Use of calcium channel blockers within 1 month prior to Screening
• Systolic blood pressure (SBP) \>160 mmHg or diastolic blood pressure (DBP) \>100 mmHg at Screening
• SBP \<90 mmHg at Screening
• Pulmonary function test: FEV1 \<60% of predicted, TLC \<60% of predicted, DLCO \<60% of predicted
• History of pulmonary embolism as judged by the Investigator
• Uncontrolled sleep apnea at the discretion of the Investigator
• Limited full participation in the 6MWT due to arthritic, neuromuscular, vascular or other diseases unrelated to PAH
• History of acute cardiovascular and/or cerebrovascular events within 6 months before Screening
• Echocardiogram (ECHO) demonstrating at least one of the following at Screening:
• LVEF \<50%
• Mean end-diastolic left ventricular septal and posterior wall thickness of \>12 mm
• Left atrial (LA) area on apical 4 chamber view \>20 cm2
• LA volume \>55 mL

Sponsors & Collaborators

• Gmax Biopharm LLC.: lead

Study Sites (7)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Peking Union Medical College Hospital - Dongcheng District

Beijing, China

RECRUITING

Xiangya Hospital, Central South University

Changsha, China

RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

RECRUITING

Guangdong General Hospital

Guangzhou, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hua Yao

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

• Lan Wang

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

• Wei Huang

  First Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

• Zaixin Yu

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

• Fenling Fan

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

• Zhicheng Jing

  Peking Union Medical College Hospital - Dongcheng District

  PRINCIPAL INVESTIGATOR

• Aaron Waxman

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianjun Wu

CONTACT

+8618358737112; jianjunwu@gmaxbiopharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: August 7, 2020
• Study Start: October 22, 2020
• Primary Completion: October 26, 2022
• Study Completion: June 10, 2023
• Last Updated: January 14, 2022

Record last verified: 2021-12

Locations

US (1); CN (6)