A Study of FT1 in Healthy Adult Volunteers

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

NCT06610487•Chongqing Peg-Bio Biopharm Co., Ltd.

View on ClinicalTrials.gov

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.

Detailed Description

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.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. healthy male or female subjects aged 18 to 45 years (inclusive);
•2. 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);
•3. Voluntarily participate and sign the informed consent form;
•4. Be able to complete the trial in accordance with the protocol.

Exclusion Criteria

•1. 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;
•2. 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;
•3. 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;
•4. With intestinal polyp disease or have undergone intestinal polyp surgery within 6 months before screening;
•5. 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;
•6. Positive urine test results for drug abuse (including morphine, methamphetamine, ketamine, cocaine, methylenedioxymethamphetamine, tetrahydrocannabinolic acid);
•7. History of drug use or drug abuse (including the use of prohibited substances for medical use and controlled drugs);
•8. 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;
•9. Participated in any clinical trial as a subject within 3 months before screening;
•10. Have donated blood or lost more than 400 mL of blood/plasma within 3 months before screening (except for physiological blood loss in women);
+10 more criteria

Locations (1)

Bishan Hospital of Chongqing

Chongqing, Chongqing Municipality, China

Key Dates

Start Date

August 20, 2024

Primary Completion Date

August 8, 2025

Completion Date

August 8, 2025

Last Updated

March 2, 2026

Enrollment

ACTUAL participants

Conditions

Diarrhea Caused by Drug (Disorder)

Interventions

FT1

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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