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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05977140




Registration number
NCT05977140
Ethics application status
Date submitted
28/07/2023
Date registered
4/08/2023

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

Experimental: SAD Cohort 1e - fifth dose level; food effect cohort

Experimental: SAD Cohort 1f - sixth 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
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Scientia Clinical Research Pty Ltd - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

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
Beyond Drug Development Pty Ltd.
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Resolutum Global Pty Ltd.
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Scientia Clinical Research Pty Ltd
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Christopher Argent, MD
Address 0 0
Scientia Clinical Research
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
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05977140