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A Study of FT1 in Healthy Adult Volunteers

NCT06610487 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-02

No results posted yet for this study

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)

Interventions

DRUG

FT1

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

DRUG

Placebo

Placebo will be administered.

Sponsors & Collaborators

  • Chongqing Peg-Bio Biopharm Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-20
Primary Completion
2025-08-08
Completion
2025-08-08

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06610487 on ClinicalTrials.gov