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Q4W GMA301 IV injections (300 mg) for Pulmonary Arterial Hypertension

Phase 1
Waitlist Available
Led By Jimmy Shaun Smith
Research Sponsored by Gmax Biopharm LLC.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (up to 22 weeks)
Awards & highlights

Study Summary

This trial is testing a new drug to see if it's safe and effective for treating pulmonary arterial hypertension.

Eligible Conditions
  • Pulmonary Arterial Hypertension

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (up to 22 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (up to 22 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The incidence of Treatment-emergent Adverse Events (TEAE) in subjects assigned to GMA301 compared with those assigned to placebo.
Secondary outcome measures
Comparing 6MWT distance
Comparison of GMA301 treatment effect at Week 12 versus baseline regarding the pulmonary vascular resistance (PVR) based on right heart catheterization (RHC)
Pharmacokinetics (Area under the serum concentration- time curve from time zero to the last measurable concentration)
Other outcome measures
Changes in REVEAL 2.0 risk score at Week 12 compared with baseline

Trial Design

4Treatment groups
Experimental Treatment
Group I: Q4W GMA301 IV injections (600 mg)Experimental Treatment2 Interventions
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
Group II: Q4W GMA301 IV injections (300 mg)Experimental Treatment2 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. Other: Q4W placebo IV injections Placebo is indistinguishable from GMA301
Group III: Q4W GMA301 IV injections (1800 mg)Experimental Treatment2 Interventions
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
Group IV: Q4W GMA301 IV injections (1000 mg)Experimental Treatment2 Interventions
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

Find a Location

Who is running the clinical trial?

Gmax Biopharm LLC.Lead Sponsor
Jimmy Shaun SmithPrincipal InvestigatorThe Ohio State University - Dorothy M. Davis Heart and Lung Research Institute
Kelly ChinPrincipal InvestigatorUniversity of Texas Southwestern Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential harms can be associated with Q4W GMA301 IV injections (300 mg)?

"Due to the lack of clinical data around this intervention, our Power team assessed Q4W GMA301 IV injections (300 mg) as a 1 on their safety scale. This is an early phase trial with limited evidence of both efficacy and safety."

Answered by AI

What is the aggregate of participants taking part in this research?

"Affirmative. The information on clinicaltrials.gov confirms that this research endeavor, which was initially made public on October 22nd 2020 is actively recruiting volunteers. A total of 48 participants are required to be recruited from 4 different medical centres."

Answered by AI

Are there numerous centers conducting this research within North America?

"Currently, 4 clinics are participating in the clinical trial. These include sites located in Louisville, Dallas and Boston amongst others. To reduce travel constraints when enrolling, we recommend selecting a medical centre near you."

Answered by AI

Are enrollees still being accepted into this experiment?

"The clinical trial is presently recruiting patients, as noted by the information on clinicaltrials.gov that documents its initial posting date of October 22nd 2020 and last update from December 29th 2021."

Answered by AI

Am I eligible to participate in this research study?

"In order to participate, patients must have pulmonary arterial hypertension and be between 18-75 years old. This study is recruiting 48 qualified individuals in total."

Answered by AI

Does this clinical trial include participants above the age of fifty?

"The accepted age range for this trial is from 18 to 75 years of age. Notably, there are separate studies available for people under the legal age and those above 65."

Answered by AI

Who else is applying?

What site did they apply to?
The University of Texas Southwestern Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

My condition is progressing. I am currently taking all the approved medications.
PatientReceived no prior treatments
~11 spots leftby Mar 2025