Study of CMP-CPS-001 in Healthy Volunteers
- Registration Number
- NCT06247670
- Lead Sponsor
- CAMP4 Therapeutics Corporation
- Brief 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.
- Detailed 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 & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 96
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single Ascending Dose Part CMP-CPS-001 Adult healthy volunteers in 4 cohorts of 12 will receive CMP-CPS-001 or placebo. Four dose levels will be evaluated. Single Ascending Dose Part Placebo Adult healthy volunteers in 4 cohorts of 12 will receive CMP-CPS-001 or placebo. Four dose levels will be evaluated. Multiple Ascending Dose Part CMP-CPS-001 Adult healthy volunteers in 4 cohorts of 12 will receive 3 monthly doses of either CMP-CPS-001 or placebo. Four dose levels will be evaluated. Multiple Ascending Dose Part Placebo Adult healthy volunteers in 4 cohorts of 12 will receive 3 monthly doses of either CMP-CPS-001 or placebo. Four dose levels will be evaluated.
- Primary Outcome Measures
Name Time Method Adverse events Screening (Day -36) until 42 days (SAD) or 112 days (MAD) after dosing Incidence of adverse events, including dose limiting toxicities, after administration of CMP-CPS-001
- Secondary Outcome Measures
Name Time Method Plasma PK Pre-dose (Day 1) until 42 days (SAD) or 112 days (MAD) after dosing Plasma concentration of CMP-CPS-001
Urinary excretion of CMP-CPS-001 42 days (SAD) or 111 days (MAD) after dosing Urine concentration of CMP-CPS-001
Pharmacodynamic effect of CMP-CPS-001 on ureagenesis Run-in (Day -8) until 42 days (SAD) or 112 days (MAD) after dosing Ureagenesis rate test determination
Trial Locations
- Locations (1)
Nucleus Network Brisbane (also known as Q-Pharm Pty Ltd)
🇦🇺Herston, Queensland, Australia