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A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of FT1 in Healthy Adult Volunteers

Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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: • 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:

• healthy male or female subjects aged 18 to 45 years (inclusive);

• Male subjects weighing ≥ 50.0kg, female subjects weighing ≥ 45kg; body mass index (BMI) in the range of 19.0-26.0 kg/m\^2 (inclusive);

• Voluntarily participate and sign the informed consent form;

• Be able to complete the trial in accordance with the protocol.

Locations
Other Locations
China
Bishan Hospital of Chongqing
Chongqing
Time Frame
Start Date: 2024-08-20
Completion Date: 2025-08-08
Participants
Target number of participants: 60
Treatments
Experimental: Single-dose FT1
A single dose of FT1 will be administered, subcutaneous injection
Placebo_comparator: Single-dose FT1 Placebo
A single dose of FT1 Placebo will be administered, subcutaneous injection
Experimental: Multiple-dose FT1
FT1 will be administered once weekly for 3 weeks, subcutaneous injection
Placebo_comparator: Multiple-dose FT1 Placebo
FT1 Placebo will be administered once weekly for 3 weeks, subcutaneous injection
Related Therapeutic Areas
Sponsors
Leads: Chongqing Peg-Bio Biopharm Co., Ltd.

This content was sourced from clinicaltrials.gov