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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06247670




Registration number
NCT06247670
Ethics application status
Date submitted
22/01/2024
Date registered
8/02/2024
Date last updated
12/02/2024

Titles & IDs
Public title
Study of CMP-CPS-001 in Healthy Volunteers
Scientific title
A Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study of CMP-CPS-001 in Healthy Volunteers
Secondary ID [1] 0 0
CPS-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CMP-CPS-001
Other interventions - Placebo

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.

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.


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

Other interventions: Placebo
Placebo is 0.9% normal saline solution and will be administered subcutaneously.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse events
Timepoint [1] 0 0
Screening (Day -43) until 42 days (SAD) or 112 days (MAD) after dosing
Secondary outcome [1] 0 0
Plasma PK
Timepoint [1] 0 0
Pre-dose (Day 1) until 42 days (SAD) or 112 days (MAD) after dosing
Secondary outcome [2] 0 0
Urinary excretion of CMP-CPS-001
Timepoint [2] 0 0
42 days (SAD) or 111 days (MAD) after dosing
Secondary outcome [3] 0 0
Pharmacodynamic effect of CMP-CPS-001 on ureagenesis
Timepoint [3] 0 0
Run-in (Day -14) until 42 days (SAD) or 112 days (MAD) after dosing

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/02/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Nucleus Network Brisbane (also known as Q-Pharm Pty Ltd) - Herston
Recruitment postcode(s) [1] 0 0
- Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
CAMP4 Therapeutics Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06247670
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gloria Wong, MD
Address 0 0
Q-Pharm Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Regulatory Affairs - Global Regulatory Clinical Services
Address 0 0
Country 0 0
Phone 0 0
+61 2 9289 3900
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06247670