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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07159763 | A Study to Evaluate the Safety and Efficacy of CD388 for Prevention of Influenza | PHASE3 | RECRUITING | 7,500 | — | — | Sep 25, 2025 | Jan 1, 2027 | Jun 1, 2026 | 181 | United States, Argentina +3 |
| NCT06609460 | Study of CD388 for the Prevention of Influenza in Subjects Not at Risk for Influenza Complications | PHASE2 | COMPLETED | 5,071 | — | — | Sep 20, 2024 | Sep 19, 2025 | Oct 20, 2025 | 57 | United States, United Kingdom |
| NCT05523089 | The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults | PHASE2 | COMPLETED | 59 | — | — | Sep 9, 2022 | Jul 17, 2023 | Sep 19, 2024 | 1 | United Kingdom |
Percentage of participants experiencing protocol-defined ILI occurring after administration of CD388, with influenza infection confirmed by a reverse-transcriptase polymerase chain reaction positive (RT-PCR+) result based on a nasopharyngeal (NP) swab assayed at a central laboratory (first occurrence only), as compared to placebo.
Safety and tolerability of CD388, as compared to placebo, will be evaluated by assessing the number of participants with incidences of TEAEs following the administration of study drug. TEAEs include but are not limited to adverse events (AEs), serious adverse events (SAEs), injection site reactions (ISRs), and any potentially clinically significant changes from baseline seen in vital signs, 12-lead electrocardiograms (ECGs), and clinical laboratory parameters.
Evaluation of the prophylactic effect of CD388, when compared to placebo, on VL-AUC of influenza challenge virus as determined by quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) on nasal samples starting 1 day post viral challenge.
Evaluation of the prophylactic effect of CD388, when compared to placebo, on VL-AUC of influenza challenge virus as determined by quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) on nasal samples starting 1 day post viral challenge.
| Arm | Type | Description |
|---|---|---|
| CD388 | EXPERIMENTAL | Participants are randomized to receive 450 milligrams (mg) CD388 by SQ injection. Participants are randomized at a 1:1 ratio between the 2 arms. |
| Placebo | PLACEBO_COMPARATOR | Participants are randomized to receive placebo by SQ injection. Participants are randomized at a 1:1 ratio between the 2 arms. |
| CD388 Low Dose | EXPERIMENTAL | Participants are randomized to receive a low dose of CD388 by SQ injection. Participants are randomized at a 1:1:1:1 ratio across the 4 arms. |
| CD388 Medium Dose | EXPERIMENTAL | Participants are randomized to receive a medium dose of CD388 by SQ injection. Participants are randomized at a 1:1:1:1 ratio across the 4 arms. |
| CD388 High Dose | EXPERIMENTAL | Participants are randomized to receive a high dose of CD388 by SQ injection. Participants are randomized at a 1:1:1:1 ratio across the 4 arms. |
| Placebo (Arm 1) | PLACEBO_COMPARATOR | In Cohort 1, up to 30 participants will be randomized to receive a single dose of placebo, administered by subcutaneous (SQ) injection, prior to being inoculated with the influenza challenge virus. Based on an interim analysis to be performed on data collected from the evaluation of Cohort 1 participants who have completed the inpatient phase at the time the interim analysis is performed, additional participants (of a number to be informed by the interim analysis) may be randomized into Cohort 2 in an extension of this Arm 1, to receive a single dose of placebo by SQ injection prior to viral challenge. |
| CD388 High Dose (Arm 2) | EXPERIMENTAL | In Cohort 1, up to 30 participants will be randomized to receive a single dose of 150 milligrams (mg) CD388, administered by SQ injection, prior to being inoculated with the influenza challenge virus. Based on an interim analysis to be performed on data collected from the evaluation of Cohort 1 participants who have completed the inpatient phase at the time the interim analysis is performed, additional participants (of a number to be informed by the interim analysis) may be randomized into Cohort 2 in an extension of this Arm 2, to receive a single dose of 150 mg CD388 by SQ injection prior to viral challenge. |
| CD388 Low Dose 1 (Arm 3) | EXPERIMENTAL | In Cohort 1, up to 30 participants will be randomized to receive a single dose of 50 mg CD388, administered by SQ injection, prior to being inoculated with the influenza challenge virus. Based on an interim analysis to be performed on data collected from the evaluation of Cohort 1 participants who have completed the inpatient phase at the time the interim analysis is performed, additional participants (of a number to be informed by the interim analysis) may be randomized into Cohort 2 in an extension of this Arm 3, to receive a single dose of 50mg CD388 by SQ injection prior to viral challenge. |
| CD388 Low Dose 2 (Optional Arm 4) | EXPERIMENTAL | Based on an interim analysis to be performed on data collected from the evaluation of Cohort 1 participants who have completed the inpatient phase at the time the interim analysis is performed, participants (of a number to be informed by the interim analysis) may be randomized into Cohort 2 in this Optional Arm 4, to receive a single dose of CD388 lower than 150 mg (TBD based on PK results obtained in the first-in-human study CD388.IM.SQ.1.01, as well as the interim analysis), administered by SQ injection, prior to being inoculated with the influenza challenge virus. |
| CD388 Low Dose 3 (Optional Arm 5) | EXPERIMENTAL | Based on an interim analysis to be performed on data collected from the evaluation of Cohort 1 participants who have completed the inpatient phase at the time the interim analysis is performed, participants (of a number to be informed by the interim analysis) may be randomized into Cohort 2 in this Optional Arm 5, to receive a single dose of CD388 lower than 150 mg (TBD based on PK results obtained in the first-in-human study CD388.IM.SQ.1.01, as well as the interim analysis), administered by SQ injection, prior to being inoculated with the influenza challenge virus. |
| CD388 Low Dose 4 (Optional Arm 6) | EXPERIMENTAL | Based on an interim analysis to be performed on data collected from the evaluation of Cohort 1 participants who have completed the inpatient phase at the time the interim analysis is performed, participants (of a number to be informed by the interim analysis) may be randomized into Cohort 2 in this Optional Arm 6, to receive a single dose of CD388 lower than 150 mg (TBD based on PK results obtained in the first-in-human study CD388.IM.SQ.1.01, as well as the interim analysis), administered by SQ injection, prior to being inoculated with the influenza challenge virus. |
| Name | Type | Description |
|---|---|---|
| CD388 Injection | COMBINATION_PRODUCT | CD388 liquid for injection |
| Placebo | COMBINATION_PRODUCT | Placebo to match |
| Saline placebo | DRUG | Sterile normal saline for injection |
| CD388 | COMBINATION_PRODUCT | CD388 liquid for injection |
Inclusion Criteria: 1. Must be 12 years of age or older at the time of signing the informed consent. 2. Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act \[HIPAA\] in the US) obtained from the participant before performing any...