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Also known as MK-1406 Injection, MK-1406, CD388 Injection
CD388 · 7 trials · 3 indications
Protocol-defined ILI includes: 1) Influenza infection confirmed by a reverse transcriptase-polymerase chain reaction positive (RT-PCR +) result from nasopharyngeal (NP) swab assayed at a central laboratory AND 2) New onset or worsening of ≥ 2 respiratory symptoms (nasal congestion, sore throat, or cough) OR New onset or worsening of 1 respiratory symptom (nasal congestion, sore throat, or cough) AND new onset of ≥ 1 systemic symptom (headache, feeling feverish or chills, body aches/pains, or fatigue). Number of participants experiencing protocol-defined ILI occurring after administration of MK-1406 (CD388), with influenza infection confirmed by an RT-PCR+ result based on a NP swab assayed at a central laboratory (first occurrence only), as compared to placebo will be assessed.
Participants are evaluated for the occurrence of treatment-induced ADAs following administration of each annual dose of MK-1406.
Participants are evaluated for the occurrence of treatment-boosted ADAs following administration of each annual dose of MK-1406.
Percentage of participants experiencing protocol-defined ILI occurring after administration of CD388, with central laboratory-confirmed reverse-transcriptase polymerase chain reaction positive (RT-PCR+) influenza infection based on the nasopharyngeal (NP) swab result, 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.
Geometric mean of HAI titers at 2-weeks and 4-weeks post-trial intervention against the influenza virus strains contained in the vaccine among participants receiving concomitant Fluzone® HD influenza vaccine and MK-1406 compared to participants who receive Fluzone® HD and placebo will be determined. HAI testing will be performed using validated methods in accordance with applicable Good Clinical Laboratory Practice (GCLP) and laboratory Standard Operating Procedures (SOPs). Geometric Mean Titers (GMTs) will be summarized by treatment group and influenza strain.
Seroconversion is defined as a 4-fold increase in influenza titer as measured by HAI assay at each visit compared to baseline. Seroconversion rates at 2-weeks and 4-weeks post-trial intervention against the influenza virus strains contained in the vaccine among participants receiving concomitant Fluzone® HD influenza vaccine and MK-1406 compared to participants who receive Fluzone® HD and placebo will be determined. Seroconversion rates will be summarized by treatment group and influenza strain.
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 |
|---|---|---|
| MK-1406 | EXPERIMENTAL | Participants will receive 450 milligrams (mg) dose of MK-1406 (CD388) by subcutaneous (SC) injection. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo by SC 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. |
| Fluzone® High-Dose (HD) plus MK-1406 | EXPERIMENTAL | Participants will receive open-label Fluzone® HD influenza vaccine by intramuscular (IM) injection plus MK-1406 by subcutaneous (SC) injection on Day 1. |
| Fluzone® HD plus Placebo | PLACEBO_COMPARATOR | Participants will receive open-label Fluzone® HD influenza vaccine by IM injection plus placebo by SC injection on Day 1. |
| 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 |
|---|---|---|
| MK-1406 | COMBINATION_PRODUCT | MK-1406 liquid for injection administered subcutaneously (SC) |
| Placebo | COMBINATION_PRODUCT | MK-1406 matched liquid for SC injection |
| MK-1406 Injection | COMBINATION_PRODUCT | MK-1406 liquid for injection administered subcutaneously |
| CD388 Injection | COMBINATION_PRODUCT | CD388 liquid for injection |
| Saline placebo | DRUG | Sterile normal saline for injection |
| CD388 | COMBINATION_PRODUCT | CD388 liquid for injection |
| Fluzone® High-Dose (HD) influenza vaccine | BIOLOGICAL | Fluzone® HD injectable suspension administered by intramuscular (IM) injection |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: Primary Stratum A (non-immunocompromised participants who have chronic stable medical conditions) and Primary Stratum B (participants who are immunocompromised either due to underlying disease or receipt ...
Top 6 of 9 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sinovac Biotech Ltd. | SVA | 1 | PHASE3 | Quadrivalent influenza vaccine (split virion), inactivated |
| Moderna, Inc. | MRNA | 1 | PHASE3 | mRNA-1018-H5 |
| Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | CDTX | 1 | PHASE3 | CD388 |
| Traws Pharma, Inc. | TRAW | 2 | PHASE2 | TRX-100 |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD4117, AZD5315 |
| GSK plc Sponsored ADR | GSK | 1 | PHASE1 | Flu/COVID-19 mRNA combination vaccine |
CD388 is being developed for the prevention of influenza. Clinical trials have enrolled healthy adult participants and people at risk of influenza complications, including a Phase 3 study in participants aged 12 years and older. It is an investigational product and has not been approved for any use.
CD388 is being developed by Cidara Therapeutics, Inc., which trades on the Nasdaq under the ticker CDTX. The program is also referenced as MK-1406, reflecting a partnership with Merck. Cidara is the sponsor of the clinical trials evaluating CD388 for influenza prevention.
CD388 has completed Phase 1 and Phase 2 trials and is currently in Phase 3 development. The Phase 3 trial, NCT07159763, is evaluating CD388 for the prevention of influenza and has an enrollment of 10,000 participants. Two additional trials are active and not recruiting.
No, CD388 is not FDA approved. It is an investigational drug still in clinical development. The FDA has granted CD388 Fast Track and Breakthrough Therapy designations, which are intended to expedite the review of drugs that treat serious conditions and fill an unmet medical need.
CD388 is being studied in several clinical trials. Active trials include NCT07300085, a Phase 1 immunogenicity study; NCT07225959, a Phase 2 study of annual doses; and NCT07159763, a Phase 3 efficacy trial. A completed Phase 2 trial, NCT06609460, enrolled 5,071 participants.
Yes, CD388 is also known as MK-1406. The names CD388 Injection and MK-1406 Injection refer to the same investigational product. Cidara Therapeutics developed CD388, and the MK-1406 designation reflects the compound's inclusion in Merck's development pipeline.