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This study is a single-centre, randomized, double-blind, placebo-controlled, dose escalation study to assess the safety, tolerability and PK of GMA301 Injection in healthy subjects. Two sequential dosing cohorts (at ascending dose fashion), each with 6 subjects receiving GMA301 Injection and 2 subjects receiving placebo (total of 16 subjects), will be given single doses. The doses to be administered in the two cohorts will be 1500 mg and 2000 mg respectively, or matching placebo
Full 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 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).
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Inclusion criteria
Non-smoker (no use of tobacco or nicotine products within 2 months prior to screening) with BMI > 18.5 and < 30.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females. Each cohort will include at least 2 participants of Chinese descent, if possible.
Healthy as defined by:
Females of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive methods throughout the study and for 6 months after the last study drug administration:
Male subjects must agree to avoid causing pregnancy by using a reliable method of birth control during the study and for 6 months after study drug administration and must be willing to use one of the following acceptable contraceptives:
Male subjects (including men who have had a vasectomy) with a pregnant partner must agree to use a condom from the first study drug administration until at least 6 months after study drug administration.
Male subjects must be willing not to donate sperm during the study and for 6 months following study drug administration.
Capable of consent.
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16 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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