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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05202379




Registration number
NCT05202379
Ethics application status
Date submitted
10/01/2022
Date registered
21/01/2022

Titles & IDs
Public title
CC-42344 Safety Study in Healthy Participants
Scientific title
A Phase 1 Study in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single-Ascending and Multiple-Ascending Doses of the Influenza A Virus Replication Inhibitor CC-42344
Secondary ID [1] 0 0
CC-42344-P1-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza A 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CC-42344
Treatment: Drugs - Placebo

Experimental: SAD cohort 1A - first dose level with 6 active and 2 placebo healthy participants

Experimental: SAD cohort 1B - second dose level with 6 active and 2 placebo healthy participants

Experimental: SAD cohort 1C - third dose level with 12 active and 2 placebo healthy participants; food-effect cohort

Experimental: SAD cohort 1D - fourth dose level with 6 active and 2 placebo healthy participants

Experimental: MAD cohort 2A - first dose level with 6 active and 2 placebo healthy participants dose x 14 days

Experimental: MAD cohort 2B - second dose level with 6 active and 2 placebo healthy participants dose x 14 days

Experimental: MAD cohort 2C - third dose level with 6 active and 2 placebo healthy participants dose x 14 days

Experimental: MAD cohort 2D - forth dose level with 6 active and 2 placebo healthy participants dose x 5 days

Experimental: MAD cohort 2E - forth dose level with 6 active and 2 placebo healthy participants dose x 5 days


Treatment: Drugs: CC-42344
CC-42344 capsules

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

Outcomes
Primary outcome [1] 0 0
treatment emergent adverse events
Assessment method [1] 0 0
number of participants with treatment-emergent adverse events
Timepoint [1] 0 0
Day 1 to 7 days after last dose
Primary outcome [2] 0 0
laboratory abnormalities
Assessment method [2] 0 0
number of participants with clinically significant laboratory abnormalities
Timepoint [2] 0 0
Day 1 to 7 days after last dose
Primary outcome [3] 0 0
vital signs
Assessment method [3] 0 0
number of participants with clinically significant changes from baseline in vital signs
Timepoint [3] 0 0
Day 1 to 7 days after last dose
Primary outcome [4] 0 0
ECG
Assessment method [4] 0 0
number of participants with clinically significant changes from baseline in ECGs
Timepoint [4] 0 0
Day 1 to 7 days after last dose
Secondary outcome [1] 0 0
maximum plasma concentration
Assessment method [1] 0 0
measurement of maximum plasma concentration (Cmax)
Timepoint [1] 0 0
Day 1 to 7 days after last dose
Secondary outcome [2] 0 0
time of maximum plasma concentration
Assessment method [2] 0 0
measurement of 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
Assessment method [3] 0 0
measurement of area under the plasma concentration-time curve (AUC)
Timepoint [3] 0 0
Day 1 to 7 days after last dose
Secondary outcome [4] 0 0
elimination rate constant
Assessment method [4] 0 0
measurement of elimination rate constant
Timepoint [4] 0 0
Day 1 to 7 days after last dose
Secondary outcome [5] 0 0
terminal elimination half-life
Assessment method [5] 0 0
measurement of terminal elimination half-life (t1/2)
Timepoint [5] 0 0
Day 1 to 7 days after last dose

Eligibility
Key inclusion criteria
Inclusion Criteria (main):

* Healthy males or healthy, non-pregnant, non-lactating females
* Body weight of at least 50 kg
* Body mass index between =18.0 and =32.0 kg/m2
* Good state of health (mentally and physically)
* Negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test, if required and per site policy
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria (main):

* Have received any investigational drug in a clinical research study within the previous 30 days before screening
* Have received any vaccine within 7 days prior to randomization
* History of any drug or alcohol abuse in the past 2 years
* Females of childbearing potential who are pregnant or lactating or planning to become pregnant during the study
* Clinically significant abnormal biochemistry, hematology, coagulation, or urinalysis as judged by the investigator

Study design
Purpose of the study
Other
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/03/2023
Sample size
Target
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cocrystal Pharma, Inc.
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Cocrystal Pharma Australia Pty Ltd.
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Linear Clinical Research
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Sam Salman, MD
Address 0 0
Linear Clinical Research
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


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/NCT05202379