A Study to Investigate Safe and Tolerable Dose of GMA301 Injection in Healthy Volunteers
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pulmonary Arterial Hypertension
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Two sequential dosing cohorts, each with 6 subjects receiving GMA301 Injection and 2 subjects receiving placebo (total of 16 subjects). The doses to be administered will be 1500 mg and 2000 mg, or matching placebo, single dosing. Each cohort will include at least 2 participants of Chinese descent, if possible.Masking: Double (Participant, Investigator)Masking Description: The subjects and the clinical personnel involved in the collection, monitoring, revision, or evaluation of AEs, or personnel who could have an impact on the outcome of the study will be blinded with respect to the subject's treatment assignment (GMA301 Injection or placebo). Blinding will be maintained at least until the clinical phase of the study is completed (i.e., when reporting and evaluation of all AEs have been completed, for all cohorts).Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 60 years
- Gender
- Both males and females
Description
The current study is an extension of the previous study #1010218 (ACTRN12618000121268) to further explore the safety and PK profile of GMA301 injection at higher dosage. The SRC (Safety Review Committee) will be responsible for the assessment of safety, tolerability, and PK data for each dose level ...
The current study is an extension of the previous study #1010218 (ACTRN12618000121268) to further explore the safety and PK profile of GMA301 injection at higher dosage. The SRC (Safety Review Committee) will be responsible for the assessment of safety, tolerability, and PK data for each dose level and to make decisions with regards to study progression. A Statistical Analysis Plan (SAP) will be written after finalizing the protocol and prior to database lock. The SAP will detail the implementation of all the planned statistical analyses in accordance with the principal features stated in the protocol. Adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA).
Tracking Information
- NCT #
- NCT04505137
- Collaborators
- Metaclinical
- Syneos Heath
- Investigators
- Principal Investigator: Sepehr Shakib, Dr CMAX Clinical Research
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