Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
80 participants
INTERVENTIONAL
2022-02-11
2023-03-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of AL-794 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses, and the Antiviral Activity of Multiple Doses in an Influenza Challenge Study
NCT02588521
Study to Assess Efficacy and Safety of XC221 in the Treatment of Influenza and Other Acute Respiratory Viral Infections
NCT03455491
First-in-Human Study of Orally Administered GS-441524 for COVID-19
NCT04859244
Study of Acute Uncomplicated Seasonal Influenza A in Adult Subjects
NCT02342249
Efficacy and Safety of Molnupiravir in Healthy Participants Inoculated With Experimental Influenza Virus (MK-4482-019)
NCT05818124
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Part 1 will involve a single-ascending (increasing) dose (SAD) where 32 participants (4 groups of 8) will be assigned randomly to receive a single oral dose of the study drug or placebo. The placebo will look the same as the study drug but will not contain any medicine. An additional 6 participants will receive a single oral dose of CC-42344 to help further understand the effect of food on the uptake of the drug.
Part 2: will involve a multiple-ascending dose (MAD) where 40 participants (5 groups of 8) will be randomized to receive an oral dose of study drug or placebo given once a day for 14 days, once a day for 5 days, or twice a day for 5 days. The placebo will look the same as the study drug but will not contain any medicine.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
OTHER
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SAD cohort 1A
first dose level with 6 active and 2 placebo healthy participants
CC-42344
CC-42344 capsules
Placebo
Placebo capsules
SAD cohort 1B
second dose level with 6 active and 2 placebo healthy participants
CC-42344
CC-42344 capsules
Placebo
Placebo capsules
SAD cohort 1C
third dose level with 12 active and 2 placebo healthy participants; food-effect cohort
CC-42344
CC-42344 capsules
Placebo
Placebo capsules
SAD cohort 1D
fourth dose level with 6 active and 2 placebo healthy participants
CC-42344
CC-42344 capsules
Placebo
Placebo capsules
MAD cohort 2A
first dose level with 6 active and 2 placebo healthy participants dose x 14 days
CC-42344
CC-42344 capsules
Placebo
Placebo capsules
MAD cohort 2B
second dose level with 6 active and 2 placebo healthy participants dose x 14 days
CC-42344
CC-42344 capsules
Placebo
Placebo capsules
MAD cohort 2C
third dose level with 6 active and 2 placebo healthy participants dose x 14 days
CC-42344
CC-42344 capsules
Placebo
Placebo capsules
MAD cohort 2D
forth dose level with 6 active and 2 placebo healthy participants dose x 5 days
CC-42344
CC-42344 capsules
Placebo
Placebo capsules
MAD cohort 2E
forth dose level with 6 active and 2 placebo healthy participants dose x 5 days
CC-42344
CC-42344 capsules
Placebo
Placebo capsules
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CC-42344
CC-42344 capsules
Placebo
Placebo capsules
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cocrystal Pharma Australia Pty Ltd.
UNKNOWN
Linear Clinical Research
INDUSTRY
Cocrystal Pharma, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sam Salman, MD
Role: PRINCIPAL_INVESTIGATOR
Linear Clinical Research
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Linear Clinical Research
Nedlands, Western Australia, Australia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CC-42344-P1-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.