A Study of GMA301 in Subjects With Pulmonary Arterial Hypertension

Status unconfirmed · Phase 1 · Has a placebo group

Conditions studied: Pulmonary Arterial Hypertension

In brief

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

Key facts

Study ID

NCT04503733

Run by

Gmax Biopharm LLC.

People needed

48

Starts

2020-10-22

Expected to finish

2023-06-10

Last updated by the study team

2022-01-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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
• If a subject has undergone RHC within 3 months before Screening, the waveform results will serve as baseline data only if they meet the entry criteria and the RHC at Screening will not be repeated. In case PAWP cannot be well measured during RHC, left ventricular end diastolic pressure will be tested by left heart catheterization.
• Has a six-minute walk test (6MWT) with distance between 150 to 450 meters at Screening
• The dosage of digitalis drugs or L-arginine supplementation must be stable for at least 1 month before Screening, if applicable.
• No new use of an IV diuretic, cardiotonic (positive inotropic agents), or vasoactive drug within 30 days before Screening
• Both male and female subjects agree to use 2 medically acceptable methods of contraception (Appendix 4) throughout the entire study period from informed consent signing to 90 days after last dose, if the possibility of conception exists. Medically acceptable methods of contraception include oral, implantable, or injectable contraceptives (starting 2 months before dosing); diaphragm with vaginal spermicide; intrauterine device; condom and partner using vaginal spermicide; and surgical sterilization (6 months after surgery). Women who are surgically sterile or those who are postmenopausal for at least 2 years are not considered to be of childbearing potential. Eligible male and female subjects must agree not to participate in a conception process (i.e. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) during the study and for 90 days after the last dose of study drug.
• Body weight no less than 40 kg at Screening
• Able to understand and willing to sign the Informed Consent Form (ICF) and comply with the study procedures.

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
• LA volume index >34 mL/m2
• Significant valvular heart disease including moderate or severe mitral or aortic stenosis with an aortic valve area <1.0 cm2 or mitral valve area <1.5 cm2, greater than moderate aortic or mitral regurgitation, greater than moderate tricuspid or pulmonic stenosis
• Restrictive, dilated or hypertrophic cardiomyopathy or constrictive pericarditis
• Using non-oral prostacyclin when Screening
• Laboratory parameters during Screening:
• Baseline aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2 times the upper limit of normal (ULN) or total bilirubin ≥1.5 times ULN
• Estimated glomerular filtration rate (eGFR) <60 mL/min by Cockcroft-Gault formula
• Online calculation available from https://www.kidney.org/professionals/KDOQI/gfr_calculatorCoc
• Cockcroft-Gault formula (1973):
• Male: CCr=((l40-Age) × Weight)/(72×SCr)

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• Peking Union Medical College Hospital - Dongcheng District — Beijing, China (enrolling)
• Xiangya Hospital, Central South University — Changsha, China (enrolling)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, China (enrolling)
• Guangdong General Hospital — Guangzhou, China (enrolling)
• Shanghai Pulmonary Hospital — Shanghai, China (enrolling)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, China (enrolling)

Full record on ClinicalTrials.gov

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