Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CC-42344 · 2 trials · 1 indication
Determined by quantitative real time reverse transcriptase polymerase chain reaction (qRT-PCR) on nasal samples
AE was defined as any new unfavorable or unintended sign, symptom, or disease or change of an existing condition, which occurs during or after treatment, whether or not considered treatment-related. A clinically significant laboratory value should be reported as an adverse event.
Number of participants with clinically significant laboratory abnormalities was reported.
Number of participants with clinically significant changes from baseline in vital signs was reported
Number of participants with clinically significant changes from baseline in ECG was reported
AE was defined as any new unfavorable or unintended sign, symptom, or disease or change of an existing condition, which occurs during or after treatment, whether or not considered treatment-related. A clinically significant laboratory value should be reported as an adverse event.
Number of participants with clinically significant laboratory abnormalities was reported
Number of participants with clinically significant changes from baseline in vital signs was reported
Number of participants with clinically significant changes from baseline in ECGs was reported.
| Arm | Type | Description |
|---|---|---|
| CC-42344 Dose 1 | EXPERIMENTAL | Low dose group |
| CC-42344 Dose 2 | EXPERIMENTAL | High dose group |
| Placebo | PLACEBO_COMPARATOR | - |
| SAD cohort 1A | EXPERIMENTAL | first dose level with 6 active and 2 placebo healthy participants |
| SAD cohort 1B | EXPERIMENTAL | second dose level with 6 active and 2 placebo healthy participants |
| SAD cohort 1C | EXPERIMENTAL | third dose level with 12 active and 2 placebo healthy participants; food-effect cohort |
| SAD cohort 1D | EXPERIMENTAL | fourth dose level with 6 active and 2 placebo healthy participants |
| MAD cohort 2A | EXPERIMENTAL | first dose level with 6 active and 2 placebo healthy participants dose x 14 days |
| MAD cohort 2B | EXPERIMENTAL | second dose level with 6 active and 2 placebo healthy participants dose x 14 days |
| MAD cohort 2C | EXPERIMENTAL | third dose level with 6 active and 2 placebo healthy participants dose x 14 days |
| MAD cohort 2D | EXPERIMENTAL | forth dose level with 6 active and 2 placebo healthy participants dose x 5 days |
| MAD cohort 2E | EXPERIMENTAL | forth dose level with 6 active and 2 placebo healthy participants dose x 5 days |
| Name | Type | Description |
|---|---|---|
| CC-42344 | DRUG | Anti-influenza A agent |
| Placebo | DRUG | Matching placebo |
Inclusion Criteria: * Healthy adults * Body weight ≥50 kg * Body mass index ≥18 kg/m2 and ≤35 kg/m2 * Serology results consistent with susceptibility to challenge virus infection Exclusion Criteria: * History of or current significant medical condition * Upper or lower respiratory tract infection...
CC-42344 is an investigational small molecule being developed for the treatment of influenza A. It is currently in Phase 2 clinical development and has been studied in healthy participants in safety and viral challenge trials.
CC-42344 is being developed by Cocrystal Pharma, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol COCP. The company is advancing the drug through clinical trials for influenza A.
CC-42344 is in Phase 2 clinical development. It has completed a Phase 1 safety study and a Phase 2 influenza viral challenge study, both in healthy participants.
CC-42344 has been studied in two completed trials. NCT05202379 was a Phase 1 safety study in 80 healthy participants in Australia. NCT06160531 was a Phase 2 influenza viral challenge study in 78 healthy participants in the United Kingdom.
CC-42344 is not FDA approved. It is an investigational drug still in clinical development, with completed Phase 1 and Phase 2 trials for influenza A.