Study of CMP-CPS-001 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-05

Study Completion Date

2025-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

CMP-CPS-001

Intervention Type DRUG

CMP-CPS-001 consists of an antisense oligonucleotide solution that will be administered subcutaneously.

Placebo

Intervention Type OTHER

Placebo is 0.9% normal saline solution and will be administered subcutaneously.

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.

Group Type EXPERIMENTAL

CMP-CPS-001

Intervention Type DRUG

CMP-CPS-001 consists of an antisense oligonucleotide solution that will be administered subcutaneously.

Placebo

Intervention Type OTHER

Placebo is 0.9% normal saline solution and will be administered subcutaneously.

Interventions

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CMP-CPS-001

CMP-CPS-001 consists of an antisense oligonucleotide solution that will be administered subcutaneously.

Intervention Type DRUG

Placebo

Placebo is 0.9% normal saline solution and will be administered subcutaneously.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes