Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000446460p
Ethics application status
Submitted, not yet approved
Date submitted
26/04/2025
Date registered
13/05/2025
Date last updated
13/05/2025
Date data sharing statement initially provided
13/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A healthy volunteer study to test a new drug, CNT2130
Scientific title
A randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of CNT2130 after single ascending dose administrations in healthy participants
Secondary ID [1] 314276 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Nephropathy 337213 0
Condition category
Condition code
Renal and Urogenital 333623 333623 0 0
Kidney disease
Metabolic and Endocrine 333723 333723 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CNT2130 is an oral capsule that will be administered in 3 groups. Group 1 will administer a dose of 15 milligrams (mg). Group 2 will administer a dose of 45 mg, and Group 3 will administer a dose of 90 mg. A single dose will be administered once in each group by the research staff. The research staff will perform a mouth check after dosing for compliance.
Intervention code [1] 330887 0
Treatment: Drugs
Comparator / control treatment
Placebo is methylcellulose powder without any active ingredient. Placebo will be administered once by the research staff.
Control group
Placebo

Outcomes
Primary outcome [1] 341229 0
Safety and tolerability (composite) of CNT2130 after single administration.
Timepoint [1] 341229 0
1. Adverse events from Day 1 to Day 8. 2. Relationship of adverse events to CNT2130 from Day 1 to Day 8. 3. Laboratory blood tests at screening, Day -1, Day 2, and Day 8. 4. Urine samples at screening, Day -1, Day 2, and Day 8. 5. Vital signs at screening, Day 1, Day 2, and Day 8. 6. ECGs at screening, Day 1, Day 2, and Day 8. 7. Physical exam at screening and as needed (as determined by the study doctor). 8. Neurological exam at screening and Day 8.
Secondary outcome [1] 446840 0
CNT2130 pharmacokinetics
Timepoint [1] 446840 0
Pre-dose, and 0.25, 0.5, 1, 2, 4, 6, 12, 24, 48, and 168 hours post-dose

Eligibility
Key inclusion criteria
1. Males and females ages 18 to 55 years old, inclusive, at screening.
2. Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at screening.
3. Weight greater than or equal to 50 kg for males and greater than or equal to 45 kg for females.
4. Ability and willingness to abstain from alcohol from 24 hours prior to admission to the clinical research center through discharge.
5. Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of any clinically significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, metabolic, psychological, musculoskeletal disease, malignancies, significant allergies (except for untreated, asymptomatic seasonal allergies at the time of dosing), immunosuppressive conditions or medications, recent or recurrent infections, or any other clinically significant disease, as assessed by the Investigator. Basal cell or squamous cell carcinoma of the skin that has been fully excised and is considered cured is acceptable.
2. Any history of alcohol abuse or drug addiction (including cannabis products) as defined by local guidance.
3. Positive drug screen (cannabinoids (marijuana), amphetamines, methamphetamines, opiates, methadone, cocaine, benzodiazepines, barbiturates, 3,4-methylenedioxymethamphetamine (MDMA), phencyclidine, and tricyclic antidepressants).
4. Average intake of > 14 units of alcohol per week for females and > 21 units of alcohol per week for males (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits).
5. Unwillingness to refrain from strenuous exercise within 96 hours (4 days) prior to admission.
6. Positive for hepatitis B surface antigen (HbsAg), anti-hepatitis C virus (HCV) antibodies or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies.
7. Participation in any investigational drug study within 30 days of Day 1, or within 5 half-lives of the drug (whichever is longer), or have participated in more than 4 investigational drug studies within 12 months of screening.
8. Donation or loss of more than 500 mL of blood or blood products within 60 days of screening, or plasma donations in the last 30 days prior to screening.
9. Received a live vaccine within 4 weeks prior to screening.
10. Any other medical condition or social circumstance, which in the opinion of the Investigator, would impede compliance with or hinder completion of the study

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/07/2025
Actual
Date of last participant enrolment
Anticipated
15/09/2025
Actual
Date of last data collection
Anticipated
22/09/2025
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 318795 0
Commercial sector/Industry
Name [1] 318795 0
Centaurus Therapeutics Pty Ltd
Country [1] 318795 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Centaurus Therapeutics Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 321260 0
None
Name [1] 321260 0
Address [1] 321260 0
Country [1] 321260 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317403 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 317403 0
Ethics committee country [1] 317403 0
Australia
Date submitted for ethics approval [1] 317403 0
07/05/2025
Approval date [1] 317403 0
Ethics approval number [1] 317403 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140950 0
Dr Tony Le
Address 140950 0
CMAX Clinical Research. Ground Floor, 21/24 North Terrace, Adelaide SA 5000
Country 140950 0
Australia
Phone 140950 0
+61 449 044 697
Fax 140950 0
Email 140950 0
[email protected]
Contact person for public queries
Name 140951 0
Tony Le
Address 140951 0
CMAX Clinical Research. Ground Floor, 21/24 North Terrace, Adelaide SA 5000
Country 140951 0
Australia
Phone 140951 0
+61 449 044 697
Fax 140951 0
Email 140951 0
[email protected]
Contact person for scientific queries
Name 140952 0
Tony Le
Address 140952 0
CMAX Clinical Research. Ground Floor, 21/24 North Terrace, Adelaide SA 5000
Country 140952 0
Australia
Phone 140952 0
+61 1800 150 433
Fax 140952 0
Email 140952 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.