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Also known as MK-1406 Injection, MK-1406, CD388 Injection
CD388 · 3 trials · 1 indication
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.
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.
| 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. |
| 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 |
| CD388 Injection | COMBINATION_PRODUCT | CD388 liquid for injection |
| Saline placebo | DRUG | Sterile normal saline for injection |
| CD388 | COMBINATION_PRODUCT | CD388 liquid for 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 8 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | mRNA Seasonal Flu vaccine, Flu/COVID-19 mRNA combination vaccine |
| Sinovac Biotech Ltd. | SVA | 1 | PHASE3 | Quadrivalent influenza vaccine (split virion), inactivated |
| Moderna, Inc. | MRNA | 2 | PHASE3 | mRNA-1018-H5, mRNA-1010, Fluarix Trivalent |
| 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 |
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE1 | H5N8 pandemic influenza vaccine (adjuvanted) |
| Hoffmann-La Roche | RHHBY | 2 | PHASE3 | Baloxavir Marboxil |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD4117, AZD5315 |
CD388 is being developed for the prevention of influenza. It is an investigational antiviral candidate studied in both healthy volunteers and people at risk of influenza complications. The clinical program includes a Phase 3 trial and two completed Phase 2 trials, with a combined enrollment of more than 15,000 participants.
CD388 is being developed by Cidara Therapeutics, Inc., which trades on the Nasdaq under the ticker CDTX. The company is the sponsor of the clinical program, including the ongoing Phase 3 trial and the completed Phase 2 studies. The drug is also referred to as MK-1406 in some study titles.
CD388 is in Phase 3 clinical development. The pivotal trial, NCT07159763, is currently recruiting an estimated 10,000 participants to evaluate the safety and efficacy of MK-1406/CD388 for influenza prevention. Two earlier Phase 2 trials have been completed.
CD388 has been studied in three clinical trials. The ongoing Phase 3 trial is NCT07159763, a randomized, double-blind, placebo-controlled study enrolling about 10,000 participants across the United States, Argentina, Australia, South Africa, and the United Kingdom. Completed Phase 2 trials include NCT06609460, which enrolled 5,071 participants, and NCT05523089, an influenza challenge study with 59 healthy adults.
Yes, CD388 is also known as MK-1406. The names appear together in the Phase 3 trial title, which refers to MK-1406/CD388. Other designations used for the asset include MK-1406 Injection and CD388 Injection. All refer to the same investigational influenza prevention candidate.
CD388 has received two FDA designations: Fast Track and Breakthrough Therapy. These designations are intended to expedite the development and review of drugs that treat serious conditions and fill an unmet medical need. The drug remains investigational and is not approved for any indication.