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A Study of PJ009 in Healthy Adult Volunteers

NCT06523101 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-07-29

No results posted yet for this study

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.

Conditions

  • Short Bowel Syndrome

Interventions

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.

Sponsors & Collaborators

  • Chongqing Peg-Bio Biopharm Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Ruigang Hou · Second Hospital of Shanxi Medical University

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
2023-02-28
Primary Completion
2023-05-15
Completion
2023-05-15

Countries

  • China

Study Locations

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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 NCT06523101 on ClinicalTrials.gov