NCT06523101

A Study of PJ009 in Healthy Adult Volunteers

A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PJ009 in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (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 PJ009 in healthy adult volunteers aged 18-45. The main questions it aims to answer are: * Is PJ009 safe in healthy adult? Participants will * Receive single dose of PJ009 or placebo according to weight, and then multiple doses daily for 7 days, * Stay in hospital for assessment.

Detailed description

This is a single center, randomized, double-blind, placebo-controlled phase 1 clinical study, aiming to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PJ009 in healthy adult volunteers.

Conditions

• Short Bowel Syndrome

Interventions

Type	Name	Description
DRUG	PJ009	Six participants in each dose level will be randomized to receive a single dose and/or multiple doses of PJ009 in a double-blind fashion.
DRUG	Placebo	Two participants in each dose level will be randomized to receive placebo in a double-blind fashion.

Timeline

• Start date: 2023-02-28
• Primary completion: 2023-05-15
• Completion: 2023-05-15
• First posted: 2024-07-26
• Last updated: 2024-07-29

Locations

1 site across 1 country: China