Pulmonary Arterial HypertensionPhase 1NCT04503733
A Study of GMA301 in Subjects With Pulmonary Arterial Hypertension
A Phase 1 study testing Q4W GMA301 IV injections (300 mg), Q4W GMA301 IV injections (600 mg) and Q4W GMA301 IV injections (1000 mg) in people with Pulmonary Arterial Hypertension, run by Gmax Biopharm LLC. at 7 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Q4W GMA301 IV injections (300 mg), Q4W GMA301 IV injections (600 mg) and Q4W GMA301 IV injections (1000 mg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 22 Oct 2020to 10 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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/gfrcalculatorCoc
- Cockcroft-Gault formula (1973):
- Male: CCr=((l40-Age) × Weight)/(72×SCr)
- Female: CCr={((l40-Age) × Weight)/(72×SCr)}× 0.85
- CCr (creatinine clearance rate) = mL/min
- Age = year
- Weight = Kg
- SCr (serum creatinine) = mg/dL
- Hemoglobin concentration ≤100 g/L at Screening
- QTc interval by Fridericia's criteria (QTcF) ≥500 msec at Screening
- 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)
- Alcohol or drug abuse within 1 year before Screening
- A psychiatric, addictive or other disorder that compromises the ability to give informed consent for participating in this study
- History of organ transplantation
- Pregnant or nursing females
- History of HIV
- Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), or HIV antibody (HIV-ab)
- Enrolled in another interventional study within 30 days before Screening
- Any condition that, in the opinion of the Investigator, prevents a potential subject from safely participating in the study
- Start a new exercise program or participate in any unusually strenuous physical exertion within 6 weeks prior to Screening.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
China6 sites, 6 recruiting
- Recruiting
Peking Union Medical College Hospital - Dongcheng District
Beijing
Zhicheng Jing
- Recruiting
Xiangya Hospital, Central South University
Changsha
Zaixin Yu
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Wei Huang
- Recruiting
Guangdong General Hospital
Guangzhou
Hua Yao
- Recruiting
Shanghai Pulmonary Hospital
Shanghai
Lan Wang
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Fenling Fan
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Aaron Waxman
About this study
Official title: A Randomized, Double-blind, Placebo-Controlled, Dose Escalation Study to Assess Safety, Efficacy and Pharmacokinetics of GMA301 in Subjects With Pulmonary Arterial Hypertension
A Randomized, Placebo-Controlled, Double-blind, Dose Escalation Study to Assess Safety, Efficacy and Pharmacokinetics of GMA301 Injection in Subjects with Pulmonary Arterial Hypertension
Read the 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
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Q4W GMA301 IV injections (300 mg), Q4W GMA301 IV injections (600 mg), Q4W GMA301 IV injections (1000 mg), Q4W GMA301 IV injections (1800 mg), Q4W placebo IV injections
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 (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 (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 (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 placebo IV injectionsOther
Placebo is indistinguishable from GMA301.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Q4W GMA301 IV injections (1800 mg); Other: Q4W placebo IV injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of Treatment-emergent Adverse Events (TEAE) in subjects assigned to GMA301 compared with those assigned to placebo.
Measured: 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)
Measured: 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)
Measured: Baseline to Week 12
Comparing 6MWT distance
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start22 Oct 2020
- Primary completion26 Oct 2022 (estimated)
- Study completion10 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gmax Biopharm LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hua Yao, Principal investigator, Guangdong Provincial People's HospitalLan Wang, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, ChinaWei Huang, Principal investigator, First Affiliated Hospital of Chongqing Medical UniversityZaixin Yu, Principal investigator, Xiangya Hospital of Central South UniversityFenling Fan, Principal investigator, First Affiliated Hospital Xi'an Jiaotong UniversityZhicheng Jing, Principal investigator, Peking Union Medical College Hospital - Dongcheng DistrictAaron Waxman, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503733
- Sponsor's protocol ID
- GETA_MAD_01
- Status last verified
- Dec 2021
- First submitted
- 24 Jul 2020
- Last updated
- 14 Jan 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-Controlled, Dose Escalation Study to Assess Safety, Efficacy and Pharmacokinetics of GMA301 in Subjects With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT04503733
- Acronym / sponsor ID
- GETA_MAD_01
- Conditions
- Pulmonary Arterial Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Gmax Biopharm LLC.Industry (pharma, biotech, devices)
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 26 Oct 2022 (estimated)
- Study completion
- 10 Jun 2023 (estimated)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Q4W GMA301 IV injections (300 mg) | Experimental | Drug: Q4W GMA301 IV injections (300 mg), Other: Q4W placebo IV injectionsDrug: 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) | Experimental | Drug: Q4W GMA301 IV injections (600 mg), Other: Q4W placebo IV injectionsDrug: 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) | Experimental | Drug: Q4W GMA301 IV injections (1000 mg), Other: Q4W placebo IV injectionsDrug: 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) | Experimental | Drug: Q4W GMA301 IV injections (1800 mg), Other: Q4W placebo IV injectionsDrug: 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Male or female, aged 18 to 75 years inclusive
- WHO Group 1 PAH related to one of the following conditions:
- 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
Key exclusion criteria (42 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 (300 mg) |
| 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 (600 mg) |
| 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 (1000 mg) |
| 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. | Drug | Q4W GMA301 IV injections (1800 mg) |
| Q4W placebo IV injectionsPlacebo is indistinguishable from GMA301. | Other | Q4W GMA301 IV injections (1000 mg), Q4W GMA301 IV injections (1800 mg), Q4W GMA301 IV injections (300 mg), Q4W GMA301 IV injections (600 mg) |
Primary outcome
The incidence of Treatment-emergent Adverse Events (TEAE) in subjects assigned to GMA301 compared with those assigned to placebo.
Time frame: Through study completion (up to 22 weeks)
3 secondary outcomes
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)
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
Comparing 6MWT distance
Time frame: Baseline to Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hua Yao principal investigator
Guangdong Provincial People's Hospital
Lan Wang principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
Wei Huang principal investigator
First Affiliated Hospital of Chongqing Medical University
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Q4W GMA301 IV injections (300 mg), Q4W GMA301 IV injections (600 mg) and Q4W GMA301 IV injections (1000 mg) in people with Pulmonary Arterial Hypertension, run by Gmax Biopharm LLC. at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianjun Wu (+8618358737112, jianjunwu@gmaxbiopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of Treatment-emergent Adverse Events (TEAE) in subjects assigned to GMA301 compared with those assigned to placebo. (time frame: Through study completion (up to 22 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.