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Study of CMP-CPS-001 in Healthy Volunteers and Participants With Abnormal Heterozygous OTC Genotype

NCT06247670 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-22

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers
  • OTC Deficiency

Interventions

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.

Sponsors & Collaborators

  • CAMP4 Therapeutics Corporation

    lead INDUSTRY

Principal Investigators

  • Gloria Wong, MD · Q-Pharm Pty Ltd

  • Margreet Wagenmakers · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-05
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • Australia
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06247670 on ClinicalTrials.gov