Study of CMP-CPS-001 in Healthy Volunteers

Last updated: June 9, 2025
Sponsor: CAMP4 Therapeutics Corporation
Overall Status: Active - Recruiting

Phase

1

Condition

Healthy Volunteers

Treatment

CMP-CPS-001

Placebo

Clinical Study ID

NCT06247670
CPS-101
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The objective of this clinical study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of CMP-CPS-001 administered as a subcutaneous injection in adult healthy volunteers.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy adults 18 to 55 years inclusive at time of informed consent

  • BMI ≥18.0 and ≤32 kg/m2 at screening, and ≤110 kg

  • Willing and able to sign informed consent form

Exclusion

Exclusion Criteria:

  • Any significant disease or disorder which, in the opinion of the Investigator, mayeither put the study participant at risk because of participation in the study, mayinfluence the results of the study, or may affect the study participant's ability toparticipate in the study

  • Clinically relevant illness within 7 days before the first dose of study drug

  • History of intolerance to subcutaneous injection or relevant abdominal scarring

  • Laboratory results outside normal ranges at screening and judged as clinicallyrelevant by the Investigator for liver function, kidney function, and platelets

  • Positive viral serology test results for human immunodeficiency virus type 1 or 2antibodies, hepatitis B surface antigen or hepatitis C virus antibody

  • Any other safety laboratory result considered clinically significant andunacceptable by the Investigator

Study Design

Total Participants: 96
Treatment Group(s): 2
Primary Treatment: CMP-CPS-001
Phase: 1
Study Start date:
February 05, 2024
Estimated Completion Date:
August 31, 2025

Study Description

This is a randomized, double-blind (Sponsor-open), and placebo-controlled study.

The SAD part will be conducted in approximately 48 healthy volunteers, in 4 cohorts of 12, randomized 3:1 to receive a single subcutaneous dose of CMP-CPS-001 or placebo. Participants will be followed for 42 days after dosing.

The MAD part will be conducted in approximately 48 healthy volunteers, in 4 cohorts of 12, randomized 3:1 to receive 3 monthly doses of CMP-CPS-001 or placebo. Participants will be followed for 56 days after the last dose.

Connect with a study center

  • Nucleus Network Brisbane (also known as Q-Pharm Pty Ltd)

    Herston, Queensland
    Australia

    Active - Recruiting

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