Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06160531 | Influenza Viral Challenge Study of CC-42344 in Healthy Participants | PHASE2 | COMPLETED | 78 | — | — | Nov 25, 2023 | Jul 18, 2024 | Aug 5, 2025 | 1 | United Kingdom |
| NCT05202379 | CC-42344 Safety Study in Healthy Participants | PHASE1 | COMPLETED | 80 | — | — | Feb 11, 2022 | Mar 29, 2023 | Feb 19, 2026 | 1 | Australia |
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...