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Study of CMP-CPS-001 in Healthy Volunteers and Participants With Abnormal Heterozygous OTC Genotype
Sponsor: CAMP4 Therapeutics Corporation
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 and participants with abnormal heterozygous OTC genotype.
Official title: A Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Phase 1 Study of CMP-CPS-001 in Healthy Volunteers and Participants With Abnormal Heterozygous Ornithine Transcarbamylase (OTC) Genotype
Key Details
Gender
All
Age Range
16 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2024-02-05
Completion Date
2027-12
Last Updated
2026-04-22
Healthy Volunteers
Yes
Conditions
Interventions
CMP-CPS-001
CMP-CPS-001 consists of an antisense oligonucleotide solution that will be administered subcutaneously.
Placebo
Placebo is 0.9% normal saline solution and will be administered subcutaneously.
Locations (2)
Nucleus Network Brisbane (also known as Q-Pharm Pty Ltd)
Herston, Queensland, Australia
Erasmus MC
Rotterdam, Netherlands