Study of CMP-CPS-001 in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06247670
• Other study ID #: CPS-101
• Status: Recruiting
• Phase: Phase 1
• Start date: February 5, 2024
• Est. completion date: August 2025

Study information

• Verified date: June 2024
• Source: CAMP4 Therapeutics Corporation
• Contact: Regulatory Affairs - Global Regulatory Clinical Services
• Phone: +61 2 9289 3900
• Email: regulatoryaffairsanz[@]iconplc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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 Criteria:

• 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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

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

Locations

Country	Name	City	State
Australia	Nucleus Network Brisbane (also known as Q-Pharm Pty Ltd)	Herston	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
CAMP4 Therapeutics Corporation

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Incidence of adverse events, including dose limiting toxicities, after administration of CMP-CPS-001	Screening (Day -36) until 42 days (SAD) or 112 days (MAD) after dosing
Secondary	Plasma PK	Plasma concentration of CMP-CPS-001	Pre-dose (Day 1) until 42 days (SAD) or 112 days (MAD) after dosing
Secondary	Urinary excretion of CMP-CPS-001	Urine concentration of CMP-CPS-001	42 days (SAD) or 111 days (MAD) after dosing
Secondary	Pharmacodynamic effect of CMP-CPS-001 on ureagenesis	Ureagenesis rate test determination	Run-in (Day -8) until 42 days (SAD) or 112 days (MAD) after dosing