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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT04503733
Date of registration:	24/07/2020
Prospective Registration:	No
Primary sponsor:	Gmax Biopharm LLC.
Public title:	A Study of GMA301 in Subjects With Pulmonary Arterial Hypertension
Scientific title:	A Randomized, Double-blind, Placebo-Controlled, Dose Escalation Study to Assess Safety, Efficacy and Pharmacokinetics of GMA301 in Subjects With Pulmonary Arterial Hypertension
Date of first enrolment:	July 1, 2020
Target sample size:	36
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT04503733
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
Phase:	Phase 1

Countries of recruitment
China	United States

Contacts

Name:	Jimmy Shaun Smith
Address:
Telephone:
Email:
Affiliation:	The Ohio State University - Dorothy M. Davis Heart and Lung Research Institute

Name:	Ronald Oudiz
Address:
Telephone:
Email:
Affiliation:	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Name:	Jie Li
Address:
Telephone:	+8618616661528
Email:	jieli@gmaxbiopharm.com
Affiliation:

Name:	Zaixin Yu
Address:
Telephone:
Email:
Affiliation:	Xiangya Hospital of Central South University

Name:	Wei Huang
Address:
Telephone:
Email:
Affiliation:	First Affiliated Hospital of Chongqing Medical University

Name:	Zhicheng Jing
Address:
Telephone:
Email:
Affiliation:	Peking Union Medical College Hospital - Dongcheng District

Name:	Fenling Fan
Address:
Telephone:
Email:
Affiliation:	First Affiliated Hospital Xi'an Jiaotong University

Name:	Kelly Chin
Address:
Telephone:
Email:
Affiliation:	University of Texas Southwestern Medical Center

Name:	Aaron Waxman
Address:
Telephone:
Email:
Affiliation:	Brigham and Women's Hospital

Name:	Hua Yao
Address:
Telephone:
Email:
Affiliation:	Guangdong Provincial People's Hospital

Name:	Lan Wang
Address:
Telephone:
Email:
Affiliation:	Shanghai Pulmonary Hospital, Shanghai, China

Key inclusion & exclusion criteria

Inclusion Criteria:

Subjects must meet all of the following criteria:

1. Male or female, aged 18 to 75 years inclusive

2. WHO Group 1 PAH related to one of the following conditions:

1. Idiopathic

2. Heritable

3. Drugs or toxins-induced

4. Associated with connective tissue disease

5. Associated with congenital heart disease if subjects underwent surgical
correction more than 12 months before Screening

3. Symptoms due to PAH are consistent with WHO functional class II- III;

4. Have not taken endothelin receptor antagonists (ERAs) within 3 months before
randomization.

5. 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.

6. Right heart catheterization (RHC) result meets below criteria when screening.

1. Mean pulmonary arterial pressure (PAP) =25 mmHg

2. Pulmonary vascular resistance (PVR) >3 Woods units

3. 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 if they
meet entry criteria; and the RHC at Screening will not be repeated.

7. Has a six-minute walk test (6MWT) with distance between 150 to 450 meters at
Screening.

8. The dosage of digitalis drugs or L-arginine supplementation must be stable for at
least 1 month before Screening, if applicable.

9. No new use of an IV diuretic, cardiotonic or vasoactive drug within 30 days before
screening.

10. Both male and female subjects agree to use a medically acceptable method of
contraception 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.

11. Body weight no less than 40 kg at Screening.

12. Able to understand and willing to sign the Informed Consent Form (ICF) and comply with
the study procedures.

Exclusion Criteria:

Subjects who meet any of the following criteria will not be allowed to participate in this
study:

1. Diagnosed with WHO Group II, III, IV, V of PH;

2. Using calcium channel blockers when Screening;

3. BP>160/100mmHg at Screening;

4. Systolic BP <90 mmHg at Screening;

5. Pulmonary function test: FEV1<60% of predicted, TLC<60% of predicted, DLCO<60% of
predicted;

6. One of the following tests with confirmed pulmonary embolism and/or chronic
thrombo-embolic pulmonary hypertension (CTEPH) following initial diagnosis of PAH:

1. Pulmonary ventilation/perfusion scan

2. CT pulmonary angiogram

3. Contrast dye pulmonary angiogram

7. History of sleep apnea.

8. Limited full participation in the 6MWT due to arthritic, neuromuscular, vascular or
other diseases unrelated to PAH.

9. History of acute cardiovascular and/or cerebrovascular events within 6 months before
screening.

10. Echocardiogram (ECHO) demonstrating at least one of the following:

1. LVEF <50%

2. Mean end-diastolic left ventricular septal and posterior wall thickness of >12 mm

3. Left atrial (LA) area on apical 4 chamber view >20 cm2

4. LA volume by biplane modified Simpsons or area-length methods >55 mL

5. LA volume index >29 mL/m2

6. 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

11. Restrictive, dilated or hypertrophic cardiomyopathy or constrictive pericarditis

12. Using non-oral prostacyclin when screening;

13. Laboratory parameters during screening:

1. Baseline aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =2
times the upper limit of normal (ULN) or total bilirubin =1.5 times ULN

2. Estimated glomerular filtration rate (eGFR) <60 mL/min by Cockcroft-Gault formula

3. Hemoglobin concentration =100 g/L at screening

14. QTc interval by Fridericia's criteria (QTcF) =500 msec at screening

15. Malignancy within 5 years before screening visit (with the exception of localized
non-metastatic basal cell carcinoma of the skin, non-metastatic carcinoma of the
prostate or in-situ carcinoma of the cervix excised with curative results)

16. Alcohol or drug abuse within 1 year before screening

17. A psychiatric, addictive or other disorder that compromises the ability to give
informed consent for participating in this study

18. History of organ transplantation

19. Pregnant or nursing females

20. History of HIV

21. Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), or HIV
antibody (HIV-ab).

22. Enrolled in another interventional study within 30 days before screening.

23. Any condition that, in the opinion of the investigator, prevents a potential subject
from safely participating in the study.

Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Q4W GMA301 IV injections (1000 mg)

Drug: Q4W GMA301 IV injections (300 mg)

Other: Q4W placebo IV injections

Drug: Q4W GMA301 IV injections (600 mg)

Primary Outcome(s)

The incidence of Treatment Emergent Adverse Events (TEAE) after the start of GMA301 dosing compared with placebo. [Time Frame: Through study completion (up to 22 weeks)]

Secondary Outcome(s)

Pharmacokinetics (Area under the serum concentration- time curve from time zero to the last measurable concentration) [Time Frame: Through study completion (up to 22 weeks)]

Comparing 6MWT distance [Time Frame: Baseline to Week 12]

Comparison of GMA301 treatment effect at Week 12 versus baseline regarding the pulmonary vascular resistance (PVR) based on right heart catheterization (RHC) [Time Frame: Baseline to Week 12]

Secondary ID(s)

GETA_MAD_01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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