A Study of FT1 in Healthy Adult Volunteers (NCT06610487) | Clinical Trial Compass
CompletedPhase 1
A Study of FT1 in Healthy Adult Volunteers
China60 participantsStarted 2024-08-20
Plain-language summary
The main aim of this clinical trial is to assess the safety of FT1 in participants aged 18 to 45 years. The main questions it aims to answer are:
ā¢ Is FT1 safe in healthy adults? Researchers will compare FT1 to a placebo (a look-alike substance that contains no drug) to see if FT1 is safe and active in human.
Participants will
* Receive one subcutaneous injection or multiple injections of FT1 or placebo according to weight.
* Visit the clinic for assessment.
Who can participate
Age range18 Years ā 45 Years
SexALL
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Inclusion criteria
ā. healthy male or female subjects aged 18 to 45 years (inclusive);
ā. Male subjects weighing ā„ 50.0kg, female subjects weighing ā„ 45kg; body mass index (BMI) in the range of 19.0-26.0 kg/m\^2 (inclusive);
ā. Voluntarily participate and sign the informed consent form;
ā. Be able to complete the trial in accordance with the protocol.
Exclusion criteria
ā. History of allergic diseases (including but not limited to asthma, urticaria, allergic rhinitis), or a history of drug allergies, or a history of allergies to the ingredients of the investigational drug;
ā. Abnormal results of vital signs, physical examination, 12 lead electrocardiogram examination, and laboratory tests (including blood routine, urine routine, blood biochemistry, coagulation function, thyroid function) during the screening period with clinically significance determined by the researcher;
ā. History or experiencing diseases with abnormal clinical manifestations, including but not limited to neurological/psychiatric, respiratory, cardiovascular, digestive, blood and lymphatic, urinary, endocrine, immune system diseases, or any other diseases or physiological conditions that may interfere with test results;
ā. With intestinal polyp disease or have undergone intestinal polyp surgery within 6 months before screening;
ā. Any positive results of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody and treponema pallidum (TP) antibody test;
What they're measuring
1
Treatment-related Adverse Events
Timeframe: up to 29 days in single-dose part, and up to 43 days in multiple-dose part
. Positive urine test results for drug abuse (including morphine, methamphetamine, ketamine, cocaine, methylenedioxymethamphetamine, tetrahydrocannabinolic acid);
ā. History of drug use or drug abuse (including the use of prohibited substances for medical use and controlled drugs);
ā. History of critical surgery within 3 months before screening or plan to undergo surgery during the trial, as well as a history of surgery that may affect drug absorption, distribution, metabolism and excretion;