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: • 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.
This study is a first-in-human study, which is a single-center, randomized, placebo-controlled, double-blind, dose escalation clinical study, aiming to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of FT1 in healthy adult volunteers. The trial is divided into 2 parts, single-dose part and multiple-dose part. In multiple-dose part, participants will receive once weekly subcutaneous injection of FT1 for 3 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
76
Bishan Hospital of Chongqing
Chongqing, Chongqing Municipality, China
RECRUITINGTreatment-related Adverse Events
To evaluate the adverse events as characterized by type, frequency, severity as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, timing, seriousness, and relationship to study therapy after administration.
Time frame: up to 29 days in single-dose part, and up to 43 days in multiple-dose part
The Area Under the Curve from dosing to the time of the last measured concentration (AUC0-t)
Pharmacokinetic parameter
Time frame: up to 29 days in single-dose part, and up to 43 days in multiple-dose part
Maximum plasma concentration (Cmax)
Pharmacokinetic parameter
Time frame: up to 29 days in single-dose part, and up to 43 days in multiple-dose part
The half-life (t1/2)
Pharmacokinetic parameter
Time frame: up to 29 days in single-dose part, and up to 43 days in multiple-dose part
Anti-drug Antibody
Immunogenicity of FT1
Time frame: up to 29 days in single-dose part, and up to 43 days in multiple-dose part
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