RecruitingPhase 1NCT06247670

Study of CMP-CPS-001 in Healthy Volunteers

A Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study of CMP-CPS-001 in Healthy Volunteers


Sponsor

CAMP4 Therapeutics Corporation

Enrollment

96 participants

Start Date

Feb 5, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria3

  • 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 Criteria6

  • Any significant disease or disorder which, in the opinion of the Investigator, may either put the study participant at risk because of participation in the study, may influence the results of the study, or may affect the study participant's ability to participate 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 clinically relevant by the Investigator for liver function, kidney function, and platelets
  • Positive viral serology test results for human immunodeficiency virus type 1 or 2 antibodies, hepatitis B surface antigen or hepatitis C virus antibody
  • Any other safety laboratory result considered clinically significant and unacceptable by the Investigator

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Interventions

DRUGCMP-CPS-001

CMP-CPS-001 consists of an antisense oligonucleotide solution that will be administered subcutaneously.

OTHERPlacebo

Placebo is 0.9% normal saline solution and will be administered subcutaneously.


Locations(1)

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

Herston, Queensland, Australia

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NCT06247670


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