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 range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. 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.