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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-520882-37-00

Acronym

CPS-101

Enrollment

Registered

2025-08-09

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urea cycle disorders (UCD)

Brief summary

1. Incidence of AEs, 2. Vital signs, 3. ECG, 4. Clinical laboratory assessment, 5. Physical examination

Detailed description

1. Plasma concentration of CO-5122, the active ingredient of CMP-CPS-001, 2. Calculated PK parameters, 3. Urine concentration of CO-5122, the active ingredient of CMP-CPS-001, 4. Ureagenesis rate test determinations

Interventions

DRUG15NH4Cl

DRUGSodium Chloride for injection

DRUG[13C]Sodium Acetate

DRUGCMP-CPS-001

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
1. Incidence of AEs, 2. Vital signs, 3. ECG, 4. Clinical laboratory assessment, 5. Physical examination	—

Secondary

Measure	Time frame
1. Plasma concentration of CO-5122, the active ingredient of CMP-CPS-001, 2. Calculated PK parameters, 3. Urine concentration of CO-5122, the active ingredient of CMP-CPS-001, 4. Ureagenesis rate test determinations	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026