Overview Study details Eligibility Things to know Research Study plan

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Overview Study details Eligibility Things to know Research Study plan

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

PHASE1ACTIVE_NOT_RECRUITING

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.

Study details:

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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

Study type

TREATMENT

Phase

PHASE1

Study ID

NCT06247670

Intervention or treatment

DRUG: CMP-CPS-001

OTHER: Placebo

Conditions

Healthy Volunteers
OTC Deficiency

Condition: Healthy Volunteers, OTC Deficiency
DRUG: CMP-CPS-001 and other drugs
Herston, Queensland, Australia
Sponsor: CAMP4 Therapeutics Corporation

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Research sites nearby

Closest Location:

Nucleus Network Brisbane (also known as Q-Pharm Pty Ltd)

Select from list below to view details:

Nucleus Network Brisbane (also known as Q-Pharm Pty Ltd)
Herston, Queensland, Australia

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Who is running the clinical trial?

CTC

CAMP4 Therapeutics Corporation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Single Ascending Dose Part Adult healthy volunteers in 4 cohorts of 12 will receive CMP-CPS-001 or placebo. Four dose levels will be evaluated.	Drug: CMP-CPS-001, Other: Placebo
EXPERIMENTAL: Multiple Ascending Dose Part 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.	Drug: CMP-CPS-001, Other: Placebo
EXPERIMENTAL: OTC Heterozygous Participants in Australia Up to 12 clinically healthy female participants who have an abnormal heterozygous OTC genotype will receive 3 monthly doses of either CMP-CPS-001 or placebo.	Drug: CMP-CPS-001, Other: Placebo
EXPERIMENTAL: OTC Heterozygous Participants in EU Up to 12 clinically healthy female participants who have an abnormal heterozygous OTC genotype will receive 3 monthly doses of either CMP-CPS-001 or placebo.	Drug: CMP-CPS-001, Other: Placebo

What is the study measuring?

Primary Outcome

Measure	Description	Time Frame
Adverse events	Incidence of adverse events, including dose limiting toxicities, after administration of CMP-CPS-001	Screening (Day -36) until 42 days (SAD) or 112 days (MAD) after dosing

Secondary Outcome

Measure	Description	Time Frame
Plasma PK	Plasma concentration of CMP-CPS-001	Pre-dose (Day 1) until 42 days (SAD) or 112 days (MAD) after dosing
Urinary excretion of CMP-CPS-001	Urine concentration of CMP-CPS-001	42 days (SAD) or 111 days (MAD) after dosing
Pharmacodynamic effect of CMP-CPS-001 on ureagenesis	Ureagenesis rate test determination	Run-in (Day -8) until 42 days (SAD) or 112 days (MAD) after dosing

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References

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

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