Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CD388 · 6 trials · 3 indications
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.
Evaluation of blood serum samples for the occurrence of treatment-emergent anti-drug antibodies (ADAs) or treatment-boosted ADAs (based on an increase in ADA titer in samples positive for ADA at baseline) directed to CD388 in participants following administration of each annual dose of CD388.
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.
Number of TEAEs reported, including but not limited to adverse events (AEs) and serious adverse events (SAEs) (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, electrocardiogram (ECG), and clinical laboratory test (including hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a single dose of CD388.
Severity of TEAEs reported, including but not limited to adverse events (AEs) and serious adverse events (SAEs) (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, electrocardiogram (ECG), and clinical laboratory test (including hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a single dose of CD388.
Number of participants with at least one TEAE, including but not limited to adverse events (AEs) and serious adverse events (SAEs) (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory test (hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a single dose of CD388.
Maximum severity of TEAEs reported (in participants with at least one TEAE), including but not limited to adverse events (AEs) and serious adverse events (SAEs) (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, electrocardiogram (ECG), and clinical laboratory test (including hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a single dose of CD388.
| Arm | Type | Description |
|---|---|---|
| CD388 (also known as MK-1406) | 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 | EXPERIMENTAL | Each participant will receive a single 450 mg dose of CD388 by subcutaneous (SQ) injection followed 1 year later by a repeat single 450 mg dose of CD388 administered by SQ injection. |
| 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. |
| Cohort 1 | EXPERIMENTAL | 9 subjects randomized in a 7:2 ratio to receive either 50 mg CD388 SQ injection or matching placebo injection |
| Cohort 2 | EXPERIMENTAL | 9 subjects randomized in a 7:2 ratio to receive either 150 mg CD388 SQ injection or matching placebo injection |
| Cohort 3 | EXPERIMENTAL | 9 subjects randomized in a 7:2 ratio to receive either 450 mg CD388 SQ injection or matching placebo injection |
| Cohort 1A (sentinel) | EXPERIMENTAL | Low dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 50 mg CD388 or placebo, administered by IM injection |
| Cohort 1A (main) | EXPERIMENTAL | Low dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 50 mg CD388 or placebo, administered by IM injection |
| Cohort 1B (sentinel) | EXPERIMENTAL | Low dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 50 mg CD388 or placebo, administered by SQ injection |
| Cohort 1B (main) | EXPERIMENTAL | Low dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 50 mg CD388 or placebo, administered by SQ injection |
| Cohort 2A (sentinel) | EXPERIMENTAL | Mid dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 150 mg CD388 or placebo, administered by IM injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose |
| Cohort 2A (main) | EXPERIMENTAL | Mid dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 150 mg CD388 or placebo, administered by IM injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose |
| Cohort 2B (sentinel) | EXPERIMENTAL | Mid dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 150 mg CD388 or placebo, administered by SQ injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose |
| Cohort 2B (main) | EXPERIMENTAL | Mid dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 150 mg CD388 or placebo, administered by SQ injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose |
| Cohort 3A (sentinel) | EXPERIMENTAL | High dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 450 mg CD388 or placebo, administered by IM injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose |
| Cohort 3A (main) | EXPERIMENTAL | High dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 450 mg CD388 or placebo, administered by IM injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose |
| Cohort 3B (sentinel) | EXPERIMENTAL | High dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 450 mg CD388 or placebo, administered by SQ injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose |
| Cohort 3B (main) | EXPERIMENTAL | High dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 450 mg CD388 or placebo, administered by SQ injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose |
| Cohort 4B (sentinel) | EXPERIMENTAL | Highest dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 900 mg CD388 or placebo, administered by SQ injection |
| Cohort 4B (main) | EXPERIMENTAL | Highest dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 900 mg CD388 or placebo, administered by SQ injection |
| 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...