Status:
COMPLETED
CC-42344 Safety Study in Healthy Participants
Lead Sponsor:
Cocrystal Pharma, Inc.
Collaborating Sponsors:
Cocrystal Pharma Australia Pty Ltd.
Linear Clinical Research
Conditions:
Influenza A
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
CC-42344 Phase 1 study with single-ascending dose (SAD) and multiple-ascending dose (MAD) parts.
Detailed Description
This study is testing the safety, tolerability, and pharmacokinetics (PK, the amount of study drug in the blood) of a new drug called CC-42344.Up to 78 healthy men or women aged between 18-55 are plan...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
Key Trial Info
Start Date :
February 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05202379
Start Date
February 11 2022
End Date
March 29 2023
Last Update
June 1 2023
Active Locations (1)
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1
Linear Clinical Research
Nedlands, Western Australia, Australia, 6009