NCT06610487

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Chongqing Peg-Bio Biopharm Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diarrhea Caused by Drug (Disorder)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-20
• Primary completion: 2025-08-08
• Completion: 2025-08-08
• First posted: 2024-09-24
• Last updated: 2026-03-02

Locations

1 site across 1 country: China