Evaluating CMP-CPS-001 in Healthy Adults
A Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study of CMP-CPS-001 in Healthy Volunteers
This study is testing a new drug called CMP-CPS-001 in healthy adults to see if it's safe and how it works in the body after different doses.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | CAMP4 Therapeutics Corporation Industry-sponsored |
| Locations | 1 site (Herston, Queensland) |
| Trial ID | NCT06247670 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of CMP-CPS-001 through single and multiple ascending doses administered via subcutaneous injection in healthy adult volunteers. The study is designed as a randomized, double-blind, placebo-controlled trial involving approximately 48 participants in each phase. The single ascending dose (SAD) phase will follow participants for 42 days, while the multiple ascending dose (MAD) phase will monitor them for 56 days after the last dose.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 to 55 with a BMI between 18.0 and 32 kg/m2.
Not a fit: Patients with significant diseases or disorders that could affect their participation or the study results will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety and efficacy of CMP-CPS-001, potentially leading to new treatments for conditions like Urea Cycle Disorder.
How similar studies have performed: While this study is focused on a specific drug, similar studies evaluating antisense oligonucleotides have shown promise in other contexts, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Herston, Queensland
- Nucleus Network Brisbane (also known as Q-Pharm Pty Ltd) — Herston, Queensland, Australia (Recruiting)
Study contacts
- Principal investigator: Gloria Wong, MD — Q-Pharm Pty Ltd
- Study coordinator: Regulatory Affairs - Global Regulatory Clinical Services
- Email: regulatoryaffairsanz@iconplc.com
- Phone: +61 2 9289 3900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.