Trial Review

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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/NCT05977140




Registration number
NCT05977140
Ethics application status
Date submitted
28/07/2023
Date registered
4/08/2023
Date last updated
31/10/2023

Titles & IDs
Public title
CDI-988 Safety Study in Healthy Participants
Scientific title
A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, First-in-Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single-Ascending and Multiple-Ascending Doses of Oral CDI-988 in Healthy Adult Participants
Secondary ID [1] 0 0
CDI-988-P1-001
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 - CDI-988
Treatment: Drugs - Placebo

Experimental: SAD Cohort 1A - first single-dose level

Experimental: SAD Cohort 1B - second single-dose level

Experimental: SAD Cohort 1C - third single-dose level; food-effect cohort

Experimental: SAD Cohort 1D - fourth single-dose level

Experimental: MAD Cohort 2A - first multiple-dose level

Experimental: MAD Cohort 2B - second multiple-dose level

Experimental: MAD Cohort 2C - third multiple-dose level


Treatment: Drugs: CDI-988
SARS-CoV-2 3CL protease inhibitor

Treatment: Drugs: Placebo
matching placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse events
Timepoint [1] 0 0
Day 1 to 7 days after last dose
Primary outcome [2] 0 0
Laboratory abnormalities
Timepoint [2] 0 0
Day 1 to 7 days after last dose
Primary outcome [3] 0 0
Vital signs
Timepoint [3] 0 0
Day 1 to 7 days after last dose
Primary outcome [4] 0 0
ECGs
Timepoint [4] 0 0
Day 1 to 7 days after last dose
Secondary outcome [1] 0 0
Maximum plasma concentration (Cmax)
Timepoint [1] 0 0
Day 1 to 3 days after last dose
Secondary outcome [2] 0 0
Time of maximum plasma concentration (Tmax)
Timepoint [2] 0 0
Day 1 to 7 days after last dose
Secondary outcome [3] 0 0
Area under the plasma concentration-time curve (AUC)
Timepoint [3] 0 0
Day 1 to 3 days after last dose
Secondary outcome [4] 0 0
Elimination rate constant (lambda Z)
Timepoint [4] 0 0
Day 1 to 3 days after last dose
Secondary outcome [5] 0 0
Terminal elimination half-life (t1/2)
Timepoint [5] 0 0
Day 1 to 3 days after last dose

Eligibility
Key inclusion criteria
- Healthy males or non-pregnant, non-lactating females

- Body weight of at least 45 kg.

- Body mass index =18.0 and =32.0 kg/m2

- Good state of mental and physical health

- Negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Received an investigational drug within 30 days

- Received a coronavirus disease 2019 (COVID-19) vaccine within 7 days

- Drug or alcohol abuse in the past 12 months

- Clinically significant abnormal biochemistry, hematology, coagulation, urinalysis test
results

- Clinically significant abnormal ECG or vital signs

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
Other
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
Actual
27/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2024
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cocrystal Pharma, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Cocrystal Pharma Australia Pty Ltd.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Nucleus Network Pty Ltd.
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Beyond Drug Development Pty Ltd.
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Resolutum Global Pty Ltd.
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The goal of this clinical trial is to learn about the safety and pharmacokinetics (PK, the
amount of drug in the blood) of a new drug called CDI-988 in healthy volunteers.

The main questions it aims to answer are:

- Are there any side effects of the drug?

- What is the amount of drug that reaches the bloodstream? Participants will be assigned
by chance to take either CDI-988 or placebo by mouth and have physical exams,
electrocardiograms (ECGs), vital signs, and blood tests to look for any side effects.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05977140
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Philip Ryan, MD, PhD
Address 0 0
Nucleus Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sam Lee, PhD
Address 0 0
Country 0 0
Phone 0 0
425-750-7208
Fax 0 0
Email 0 0
slee@cocrystalpharma.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05977140