Influenza A Clinical Trial
Official 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
CC-42344 Phase 1 study with single-ascending dose (SAD) and multiple-ascending dose (MAD) parts.
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 56 healthy men or women aged between 18-55 will be enrolled in this study in two parts. 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. Part 2: will involve a multiple-ascending dose (MAD) where 24 participants (3 groups of 8) will be randomised to receive an oral dose of study drug or placebo given once a day for 14 days. The placebo will look the same as the study drug but will not contain any medicine. ;
| NCT number | NCT05202379 |
| Study type | Interventional |
| Source | Cocrystal Pharma, Inc. |
| Contact | Sam Lee, PhD |
| Phone | (425) 750-7208 |
| [email protected] | |
| Status | Recruiting |
| Phase | Phase 1 |
| Start date | February 11, 2022 |
| Completion date | September 2022 |
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