A Study to Investigate Safe and Tolerable Dose of GMA301 Injection in Healthy Volunteers (NCT04505137) | Clinical Trial Compass
CompletedPhase 1
A Study to Investigate Safe and Tolerable Dose of GMA301 Injection in Healthy Volunteers
Australia16 participantsStarted 2020-09-02
Plain-language summary
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
Who can participate
Age range18 Years – 60 Years
SexALL
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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:
✓. The absence of clinically significant illness and surgery within 4 weeks prior to dosing.
✓. The absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
✓. 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:
✓. Oral, injected, or implanted hormonal methods of contraception in combination with a barrier method;
✓. Placement of an intrauterine device (IUD) or intrauterine system (IUS) in combination with a barrier method;
✓. Sterilized male partner (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate) in combination with a barrier method;
Exclusion criteria
✕. Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for HIV, hepatitis B, or hepatitis C found during medical screening.
What they're measuring
1
Safety and Tolerability
Timeframe: All AEs (adverse events) will be captured from the time the investigator received the signed ICF (informed consent form) of subjects until study completion ie Day 70
. Presence or history of any clinically significant chronic condition of the neurological, respiratory, cardiovascular, gastrointestinal, urogenital, reproductive, musculoskeletal, endocrine system or cancer.
✕. Clinically significant (as judged by the investigator) presence of acute illness (e.g., gastrointestinal illness, infection such as influenza, upper respiratory tract infection) upo admission to the study site.
✕. Alanine aminotransferase and/or aspartate aminotransferase above the upper limit of normal.
✕. Positive urine drug screen or alcohol breath test at screening.
✕. Positive pregnancy test at screening.
✕. Clinically significant ECG abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 60 or over 90 mmHg,or heart rate less than 40 or over 100 bpm) at screening. Up to 2 additional measurements may be taken after an appropriate resting interval (at least 10 minutes) at Screening to confirm eligibility.
✕. History of type 1 hypersensitivity or severe cutaneous adverse reaction to any medication, or to any excipient in the formulation, or history of significant atopy.