A Study of FT1 in Healthy Adult Volunteers

NCT06610487 | Completed Phase 1

• 1 other identifier: CQPJ-FT1-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diarrhea Caused by Drug (Disorder)

Keywords

Chemotherapy induced diarrhea

Outcome Measures

Primary Outcomes (1)

• Treatment-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.

  up to 29 days in single-dose part, and up to 43 days in multiple-dose part

Secondary Outcomes (4)

• The Area Under the Curve from dosing to the time of the last measured concentration (AUC0-t)

  up to 29 days in single-dose part, and up to 43 days in multiple-dose part

• Maximum plasma concentration (Cmax)

  up to 29 days in single-dose part, and up to 43 days in multiple-dose part

• The half-life (t1/2)

  up to 29 days in single-dose part, and up to 43 days in multiple-dose part

• Anti-drug Antibody

  up to 29 days in single-dose part, and up to 43 days in multiple-dose part

Study Arms (4)

Single-dose FT1

EXPERIMENTAL

A single dose of FT1 will be administered, subcutaneous injection

Drug: FT1

Single-dose FT1 Placebo

PLACEBO COMPARATOR

A single dose of FT1 Placebo will be administered, subcutaneous injection

Drug: Placebo

Multiple-dose FT1

EXPERIMENTAL

FT1 will be administered once weekly for 3 weeks, subcutaneous injection

Drug: FT1

Multiple-dose FT1 Placebo

PLACEBO COMPARATOR

FT1 Placebo will be administered once weekly for 3 weeks, subcutaneous injection

Drug: Placebo

Interventions

FT1 DRUG

Six dose levels will be evaluated in single-dose part, and three dose levels in multiple-dose part.

Multiple-dose FT1; Single-dose FT1

Placebo DRUG

Placebo will be administered.

Multiple-dose FT1 Placebo; Single-dose FT1 Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;
• 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;
• With intestinal polyp disease or have undergone intestinal polyp surgery within 6 months before screening;
• 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;
• Positive urine test results for drug abuse (including morphine, methamphetamine, ketamine, cocaine, methylenedioxymethamphetamine, tetrahydrocannabinolic acid);
• History of drug use or drug abuse (including the use of prohibited substances for medical use and controlled drugs);
• 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;
• Participated in any clinical trial as a subject within 3 months before screening;
• Have donated blood or lost more than 400 mL of blood/plasma within 3 months before screening (except for physiological blood loss in women);
• Alcoholics (i.e. males drinking more than 28 standard units of alcohol per week and females drinking more than 21 standard units of alcohol per week, with 1 standard unit containing 14g of alcohol, such as 360mL beer or 45mL of 40% spirits or 150mL wine) or those who have frequently consumed alcohol within the previous 6 months (i.e. drinking more than 14 standard units of alcohol per week), or those who cannot abstain from alcohol during the trial, or those who have a positive alcohol breath test;
• Took any prescription or over-the-counter drugs, as well as any functional vitamins or herbal products within 14 days before screening;
• Have a long-term history of excessive consumption of tea, coffee or caffeinated beverages (more than 8 cups per day, 1 cup = 250mL)
• Smoked more than 5 cigarettes per day within 6 months before screening;
• Cannot guarantee to refrain from strenuous exercise, smoking and special diet (including grapefruit, chocolate, tea, cola, or any food or beverage containing caffeine, alcoholic beverages or other food or beverage that affects drug absorption, distribution, metabolism and excretion) from 48 hours before medication to the last blood collection;

Sponsors & Collaborators

• Chongqing Peg-Bio Biopharm Co., Ltd.: lead

Study Sites (1)

Bishan Hospital of Chongqing

Chongqing, Chongqing Municipality, 402760, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: August 20, 2024
• Primary Completion: August 8, 2025
• Study Completion: August 8, 2025
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

CN (1)