A Study of PJ009 in Healthy Adult Volunteers

NCT06523101 | Completed Phase 1

• 1 other identifier: CQPJ-PJ009-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Treatment-related Adverse Events

  Number of participants with treatment-related adverse events during the study will be collected and the percentage of adverse events (AEs) of different grades as assessed by CTCAE v5.0 will be assessed.

  Up to 18 days

Study Arms (2)

PJ009 group

EXPERIMENTAL

Participants will receive a single dose of PJ009 on day1, and then multiple doses of PJ009 once daily for 7 days (day5-11). Three dose levels will be evaluated. subcutaneous injection

Drug: PJ009

PJ009 Placebo group

PLACEBO COMPARATOR

Participants will receive a single dose of PJ009 placebo on day1, and then once daily for 7 days (day5-11). subcutaneous injection

Drug: Placebo

Interventions

PJ009 DRUG

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.

Also known as: Glucagon-like Peptide-2 (GLP-2) analogue

PJ009 group

Placebo DRUG

Two participants in each dose level will be randomized to receive placebo in a double-blind fashion.

PJ009 Placebo group

Eligibility Criteria

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

You may qualify if:

• Voluntarily participate and sign the informed consent form;
• Healthy male or female subjects;
• Aged 18 to 45 years (inclusive), body weight ≥ 50kg; body mass index between 19.0 and 26.0 (inclusive), body mass index (BMI) = weight (kg)/height\^2 (m\^2);
• Female subjects of childbearing age with negative serum pregnancy test results;
• Eligible subjects of fertility must agree to use effective contraceptive measures or abstain from sex during the study and within 6 months after the study;
• Be able to understand and comply with the requirements of the protocol and expected to complete the entire study process.

You may not qualify if:

• History of allergic diseases (including but not limited to asthma, urticaria, allergic rhinitis), drug allergy, or allergy to the ingredients of the investigational drug;
• Used any drugs (including prescription drugs, over-the-counter drugs and Chinese herbal medicines) within 4 weeks before enrollment, except for external drugs that are not absorbed by the body; or used drugs known to cause significant damage to a certain organ within 12 weeks before enrollment;
• History of any serious disease, including but not limited to digestive system, cardiovascular system, respiratory system, urinary system, musculoskeletal system, endocrine system, neuropsychiatric system, blood system, immune system diseases and metabolic abnormalities, or neurological or mental disorders, such as epilepsy and dementia;
• History of congenital hemolytic hyperbilirubinemia;
• History of gallstones or gastrointestinal surgery;
• History of colorectal cancer;
• History of gastrointestinal diseases, such as malabsorption, Crohn's disease, etc;
• History of rash or dermatitis;
• The laboratory and auxiliary examination results meet any of the following conditions:
• Abnormal electrocardiogram with clinical significance determined by the investigator;
• Abnormal vital signs with clinical significance determined by the investigator;
• Positive results of HIV-Ab, HCV-Ab, HBsAg or syphilis test;
• Abnormal results of laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function) with clinical significance;
• Positive results of drug abuse or alcohol test;
• Abnormal results of chest X-ray (anterior) with clinical significance determined by the investigator;

Sponsors & Collaborators

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

Study Sites (1)

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

MeSH Terms

Conditions

Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ruigang Hou

  Second Hospital of Shanxi Medical University

  PRINCIPAL INVESTIGATOR

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: July 22, 2024
• First Posted: July 26, 2024
• Study Start: February 28, 2023
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: July 29, 2024

Record last verified: 2024-07

Locations

CN (1)