InfluenzaPhase 2NAVIGATENCT06609460
Study of CD388 for the Prevention of Influenza in Subjects Not at Risk for Influenza Complications
A Phase 2 study testing CD388 Injection in people with Influenza, run by Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 57 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the effectiveness of CD388 in preventing symptomatic laboratory-confirmed influenza infections, as compared to placebo, and to select a dose of CD388 that is effective in preventing the same, when administered as a single dose via 3 subcutaneous (SQ) injections to adult… Read more about this study
- Who is it for?
- Ages 18 to 63 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- CD388 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5,071 participants
- Where
- 57 sitesin 2 countries
- Study dates
- 20 Sep 2024to 9 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 63 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to provide written informed consent and comply with scheduled visits, laboratory tests, and other study procedures.
- Males and females 18 to less than 64 years of age.
- In the Investigator's clinical judgment, is in stable health at the time of screening and randomization. Participants may not have underlying hematologic, oncologic, renal, autoimmune, and/or cardiopulmonary illnesses or be considered at risk of developing complications from influenza infection per the CDC guidelines (chronic obstructive pulmonary disease [COPD], asthma, immune compromised current cancer [except non-melanomatous skin cancer], or diabetes). Subjects will be included on the basis of medical history and vital signs taken between signing of the informed consent and randomization.
- Body mass index (BMI; calculated as weight in kilograms [kg] divided by height in meters [m] squared) of 18.0 kg/m^2 to 35.0 kg/m^2 (inclusive).
- Women of childbearing potential (WOCBP) must:
- Have a negative pregnancy test (beta-human chorionic gonadotropin [β-hCG]) at screening, AND
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- Be practicing a highly effective, preferably user-independent method of contraception (failure rate of less than 1 percent per year when used consistently and correctly) from ≥2 weeks prior to randomization and agrees to remain on a highly effective method from Day 1 until 32 weeks after study drug administration, the end of relevant systemic exposure. The Investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the day of administration of study drug.
- A woman is considered of childbearing potential (i.e., fertile) following menarche and until becoming postmenopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
- Female participants must agree not to donate or freeze eggs (ova, oocytes) for future use for the purposes of assisted reproduction from Day 1 until 32 weeks after study drug administration.
- Male participants must wear a condom when engaging in any activity that allows for passage of ejaculate to another person from Day 1 until 32 weeks after study drug administration. Male participants should also be advised of the benefit for a female partner to additionally use a highly effective method of contraception, as condoms could break or leak.
- Note: Contraceptive (birth control) use by participants should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies.
- Male participants must agree not to donate sperm from Day 1 until 32 weeks after study drug administration.
- Participant agrees not to donate blood from Day 1 until 32 weeks after study drug administration.
- Must be able to read, understand, and complete questionnaires in the electronic diary (eDiary), work with smartphones/tablets/computers, and be willing and able to adhere to the prohibitions and restrictions specified in this protocol. If an appropriate language version is not available for the eDiary assessments, the participant should not be enrolled.
- Must be willing to provide verifiable identification, has means to be contacted, and is able to contact the Investigator/study site and communicate reliably during participation in the study.
Who cannot join
- Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to zanamivir (following administration of inhaled or intravenous formulations), monoclonal antibodies (including crystallizable fragment [Fc] domains), or any of the components of CD388 or placebo.
- Have been diagnosed with influenza (i.e., with medical history [including verbal] of influenza) within the past 6 months prior to randomization.
- Has received the current seasonal influenza vaccine prior to screening or is planning to receive the seasonal vaccine during trial participation.
- Has an acute illness (including acute respiratory illnesses) or body temperature ≥38.0ºC (≥100.4 degrees Fahrenheit [ºF]) within 7 days prior to study drug administration (Note: Enrollment at a later date, subsequent to resolution [within the screening period] is permitted).
- Has had close contact (including household contacts) with someone with laboratory-confirmed influenza or with someone who has been treated with antiviral therapies for influenza within the past 7 days prior to randomization.
- Has had close contact (including household contacts) with someone with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or coronavirus disease 2019 (COVID-19) as defined by the US CDC or has had a positive SARS-CoV-2 test within 10 days prior to screening. Please note SARS-CoV-2 testing is NOT required during screening.
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- Has a serious and/or clinically unstable condition such as psychiatric condition, including recent (within the past year) or active suicidal ideation/behavior, Alzheimer's disease, or any other condition for which, in the opinion of the Investigator, participation would not be in the participant's best interest or that could prevent, confound, or limit the protocol-specified assessments.
- Any history of alcohol or drug abuse within the past 2 years or a positive urine drug screen for drugs of abuse (other than tetrahydrocannabinol [THC]) at screening or Day 1. Note: urine drug screen that is positive for a medication prescribed for treatment of ongoing condition is not exclusionary.
- Had major surgery (e.g., major cardiopulmonary or abdominal operations) per Investigator judgment within 4 weeks prior to randomization, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study.
- Screening ECG findings of prolonged QT interval corrected for heart rate using Fridericias formula (QTcF) (greater than 450 milliseconds [msec] in males or greater than 470 msec in females), prolonged PR interval (greater than 220 msec), second- or third-degree heart block, or other clinically significant dysrhythmias.
- At the time of screening, any finding that may significantly increase the risk of participation in the study, affect the ability to participate in the study, or impair interpretation of the study data.
- Current or planned participation in another clinical study where study intervention is being administered while participating in the current study. Note: Concurrent enrollment is allowed during the follow-up phase of the other clinical study or in case the study intervention in the other clinical study is a marketed product already approved for another indication - exception being if the other study requires study interventions that could affect the safety assessments of the present study (e.g., clinical laboratory tests).
- [Exclusion criterion #13 removed during Amendment 1.1-US; placeholder remains to retain numbering of the remaining original exclusion criteria.]
- Prior receipt within the past 30 days or 5 half-lives (whichever is longer) or anticipated receipt of any drug, vaccine, or other biologic agent (e.g., monoclonal antibodies) administered for the prevention or treatment of influenza.
- Prior receipt of any experimental drug, vaccine, or biologic agent within the past 90 days or 5 half-lives (whichever is longer).
- Contraindication to SQ injections and blood draws (e.g., bleeding disorders).
- Has donated ≥450 mL of blood product (1 unit) for any reason within 30 days of screening or plans to donate blood product during the study.
- Currently pregnant or breastfeeding, intends to become pregnant or breastfeed, or has a positive pregnancy test during the screening period.
- Has direct involvement in the proposed study or other studies under the direction of the Investigator, sub-investigators, or study site; is a family member of an individual with such direct involvement; or is an employee of the Sponsor.
- In the opinion of the Investigator, is unlikely to adhere to the requirements of the study.
Trial locations and contacts
57 sites in 2 countries.
57 sites in 2 countries
United States56 sites
Velocity Clinical Research - Albuquerque
Albuquerque, New Mexico, 87107
Velocity Clinical Research - Anderson
Anderson, South Carolina, 29621
Pinnacle Research Group, LLC
Anniston, Alabama, 36207
DelRicht Research
Atlanta, Georgia, 30329
Velocity Clinical Research - Cleveland
Beachwood, Ohio, 44122
DelRicht Research
Charleston, South Carolina, 29407
DelRicht Research
Charlotte, North Carolina, 28205
Velocity Clinical Research - Springdale
Cincinnati, Ohio, 45246
Profound Research LLC
Clarkston, Michigan, 48346
Lynn Institute of the Rockies
Colorado Springs, Colorado, 80918
Cullman Clinical Trials
Cullman, Alabama, 35055
Zenos Clinical Research
Dallas, Texas, 75230
Lonestar Clinical Research, LLC
Dallas, Texas, 75243
Profound Research LLC
Farmington Hills, Michigan, 48334
Alliance for Multispecialty Research, LLC
Fort Myers, Florida, 33912
DelRicht Research
Gulfport, Mississippi, 39503
DelRicht Research
Hendersonville, Tennessee, 37075
Velocity Clinical Research - Huntington Park
Huntington Park, California, 90255
Nature Coast Clinical Research
Inverness, Florida, 34452
Health Awareness, LLC
Jupiter, Florida, 33458
Velocity Clinical Research - San Diego
La Mesa, California, 91942
Critical Care, Pulmonary & Sleep Associates, PLLP/CCT Research
Lakewood, Colorado, 80228
Alliance for Multispecialty Research, LLC
Layton, Utah, 84041
Johnson County Clin-Trials
Lenexa, Kansas, 66219
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205
DelRicht Research
Louisville, Kentucky, 40205
Velocity Clinical Research - Medford
Medford, Oregon, 97504
Velocity Clinical Research - Boise
Meridian, Idaho, 83642
South Florida Research Center, Inc.
Miami, Florida, 33135
Clinical Site Partners, LLC dba Flourish Research
Miami, Florida, 33186
Floridian Clinical Research
Miami Lakes, Florida, 33016
IMA Clinical Research
Monroe, Louisiana, 71201
Catalina Research Institute, LLC
Montclair, California, 91763
DelRicht Research
New Orleans, Louisiana, 70115
IMA Clinical Research
New York, New York, 10036
Velocity Clinical Research - Norfolk
Norfolk, Nebraska, 68701
Healthcare Clinical Data, Inc.
North Miami, Florida, 33161
Profound Research LLC
Oceanside, California, 92058
Velocity Clinical Research - Omaha
Omaha, Nebraska, 68134
Optimal Research, LLC
Peoria, Illinois, 61614
DelRicht Research
Prairieville, Louisiana, 70769
DelRicht Research
Prosper, Texas, 75078
Clinical Research Partners, LLC
Richmond, Virginia, 23226
Profound Research LLC
Rochester Hills, Michigan, 48307
Clinical Trials of Texas, LLC dba Flourish Research
San Antonio, Texas, 78229
Acclaim Clinical Research
San Diego, California, 92120
Velocity Clinical Research - Sioux City
Sioux City, Iowa, 51106
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
DelRicht Research
Springfield, Missouri, 65807
Sundance Clinical Research, LLC
St Louis, Missouri, 63141
Stephenville Medical & Surgical Clinic
Stephenville, Texas, 76401
Fiel Family and Sports Medicine/CCT Research
Tempe, Arizona, 85283
Del Sol Research Management, LLC
Tucson, Arizona, 85715
DelRicht Research
Tulsa, Oklahoma, 74133
Velocity Clinical Research - Valparaiso
Valparaiso, Indiana, 46383
Velocity Clinical Research - Salt Lake City
West Jordan, Utah, 84088
About this study
Official title: A Phase 2b Randomized, Double-blind, Placebo-controlled, Multicenter Dose Ranging Study to Evaluate Efficacy and Safety of CD388, a Novel Long-acting Antiviral Conjugate, for the Prevention of Influenza in Subjects Not at Risk for Influenza Complications
The purpose of this study is to evaluate the effectiveness of CD388 in preventing symptomatic laboratory-confirmed influenza infections, as compared to placebo, and to select a dose of CD388 that is effective in preventing the same, when administered as a single dose via 3 subcutaneous (SQ) injections to adult participants in stable health, and to evaluate the safety and tolerability of CD388, as compared to placebo.
Read the detailed description
This is a Phase 2b, randomized, double-blind, placebo-controlled, parallel-group, multicenter dose selection study to evaluate the efficacy, safety, and tolerability of 3 dose levels of CD388 administered as a single dose via 3 SQ injections in adult participants who are not at risk of developing complications from influenza.
- Conditions
- Influenza
- Being tested
- CD388 Injection, Placebo
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD388 InjectionCombination product
CD388 liquid for injection
PlaceboCombination product
Placebo to match
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: CD388 Injection |
| 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. Receives: Combination Product: CD388 Injection |
| 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. Receives: Combination Product: CD388 Injection |
| Placebo | Placebo comparator | Participants are randomized to receive placebo by SQ injection. Participants are randomized at a 1:1:1:1 ratio across the 4 arms. Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing Protocol-defined Influenza-like Illness (ILI) Occurring ≥7 Days after and up to 24 Weeks after Administration of Study Drug
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.
Measured: From Day 8 up to 24 weeks after study drug dosing
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) after Administration of Study Drug
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.
Measured: From Day 1 through Day 197/End of Study (EOS) after study drug dosing
Secondary outcomes (14)
Percentage of Participants Experiencing Protocol-defined ILI Occurring ≥7 Days after and up to 28 Weeks after Administration of Study Drug
Percentage of participants experiencing protocol-defined ILI occurring after administration of CD388, with central laboratory-confirmed RT-PCR+ influenza infection based on the NP swab result, as compared to placebo.
Measured: From Day 8 up to 28 weeks after study drug dosing
Percentage of Participants Experiencing Protocol-defined ILI (as in Primary Endpoint 1) Except with a Lower Threshold for New Onset of Fever
Percentage of participants experiencing protocol-defined ILI occurring after administration of CD388, with central laboratory-confirmed RT-PCR+ influenza infection based on the NP swab result, as compared to placebo. New onset of fever is defined as oral temperature ≥37.2 degrees Celsius (°C). Respiratory symptoms are influenza-associated and as described in the protocol. Onset events include those occurring ≥7 days after and up to 24 weeks following study drug administration.
Measured: From Day 8 up to 24 weeks after study drug dosing
Percentage of Participants Experiencing Protocol-defined ILI (as in Primary Endpoint 1) Except the Influenza Infection is Based on the Midturbinate (MT) Swab Result
Percentage of participants experiencing protocol-defined ILI occurring after administration of CD388, with the influenza infection based on the MT swab result, as compared to placebo.
Measured: From Day 8 up to 24 weeks after study drug dosing
Percentage of Participants Experiencing an Influenza Infection AND New Onset of Fever AND New Onset of ≥2 Respiratory Symptoms after Administration of Study Drug
Percentage of participants experiencing a central laboratory-confirmed RT-PCR+ influenza infection based on the NP swab result (first occurrence only) occurring after administration of CD388, as compared to placebo. New onset of fever is defined as oral temperature ≥37.8°C. Respiratory symptoms are influenza-associated and as described in the protocol. Onset events include those occurring ≥7 days after and up to 24 weeks following study drug administration.
Measured: From Day 8 up to 24 weeks after study drug dosing
Percentage of Participants Experiencing an Influenza Infection AND New Onset of ≥2 Respiratory Symptoms after Administration of Study Drug
Percentage of participants experiencing a central laboratory-confirmed RT-PCR+ influenza infection based on the NP swab result (first occurrence only) occurring after administration of CD388, as compared to placebo. Respiratory symptoms are influenza-associated and as described in the protocol. Onset events include those occurring ≥7 days after and up to 24 weeks following study drug administration.
Measured: From Day 8 up to 24 weeks after study drug dosing
Percentage of Participants Experiencing an Influenza Infection AND New Onset of ≥1 Respiratory Symptom AND New Onset of ≥1 Systemic Symptom after Administration of Study Drug
Percentage of participants experiencing a central laboratory-confirmed RT-PCR+ influenza infection based on the NP swab result (first occurrence only) occurring after administration of CD388, as compared to placebo. Respiratory symptoms are influenza-associated and as described in the protocol. Onset events include those occurring ≥7 days after and up to 24 weeks following study drug administration.
Measured: From Day 8 up to 24 weeks after study drug dosing
Percentage of Participants Experiencing an Influenza Infection, AND New Onset of ≥2 Respiratory Symptoms, OR ≥1 Respiratory Symptom AND New Onset of ≥1 Systemic Symptom, after Administration of Study Drug
Percentage of participants experiencing a central laboratory-confirmed RT-PCR+ influenza infection based on the NP swab result (first occurrence only) occurring after administration of CD388, as compared to placebo. Respiratory symptoms are influenza-associated and as described in the protocol. Onset events include those occurring ≥7 days after and up to 24 weeks following study drug administration.
Measured: From Day 8 up to 24 weeks after study drug dosing
Percentage of Participants Experiencing an Influenza Infection AND New Onset of Fever, AND New Onset of ≥2 Respiratory Symptoms, OR New Onset of ≥1 Respiratory Symptom Plus New Onset of ≥1 Systemic Symptom, after Administration of Study Drug
Percentage of participants experiencing a central laboratory-confirmed RT-PCR+ influenza infection (first occurrence only) from either the self-collected MT swab (collected prior to the initiation of any antiviral treatment) or the NP swab collected by a health professional, occurring after administration of CD388, as compared to placebo. New onset of fever is defined as oral temperature ≥38°C. Respiratory symptoms are influenza-associated and as described in the protocol. Onset events include those occurring ≥7 days after and up to 24 weeks following study drug administration.
Measured: From Day 8 up to 24 weeks after study drug dosing
Severity (as Composite Symptom Score) of Participant Reported Influenza-like Symptoms as Based on the Self-reported Responses to the Respiratory Infection Intensity and Impact Questionnaire (RiiQ™) Symptom Scale
Evaluation of the severity (defined as the composite symptom score) of participant reported influenza-like symptoms as based on the self-reported responses to the RiiQ™ Symptom Scale (scored as 0 = none, 1 = mild, 2 = moderate, and 3 = severe) as presented in the participant eDiary. The composite symptom score is defined as the mean of the scores of the non-missing influenza symptoms for each time point. From the time the participant triggers an Acute Respiratory Infection (ARI) Alert in the eDiary until the ARI episode is resolved (defined as 2 consecutive days where all influenza-associated symptoms on the RiiQ™ Symptom Scale have returned to the same severity level as reported at baseline or lower), the participant will complete the RiiQ™ Symptom Scale in the eDiary for a maximum of 29 days, per ARI episode.
Measured: On Day 1 (pre-dose baseline); and then once daily from the time the participant triggers an ARI Alert in the eDiary until the ARI episode is resolved for a maximum of 29 days per ARI episode, up to 28 weeks after study drug dosing
Severity (as Area Under the Curve [AUC]) of Participant Reported Influenza-like Symptoms as Based on the Self-reported Responses to the RiiQ™ Symptom Scale
Evaluation of the severity (presented as AUC) of participant reported influenza-like symptoms as based on the self-reported responses to the RiiQ™ Symptom Scale (scored as 0 = none, 1 = mild, 2 = moderate, and 3 = severe) as presented in the participant eDiary. AUC will be based on scores of the non-missing influenza symptoms for each time point. From the time the participant triggers an Acute Respiratory Infection (ARI) Alert in the eDiary until the ARI episode is resolved (defined as 2 consecutive days where all influenza-associated symptoms on the RiiQ™ Symptom Scale have returned to the same severity level as reported at baseline or lower), the participant will complete the RiiQ™ Symptom Scale in the eDiary for a maximum of 29 days, per ARI episode.
Measured: On Day 1 (pre-dose baseline); and then once daily from the time the participant triggers an ARI Alert in the eDiary until the ARI episode is resolved for a maximum of 29 days per ARI episode, up to 28 weeks after study drug dosing
Duration (as Time to Symptom Resolution) of Participant Reported Influenza-like Symptoms as Based on the Self-reported Responses to the RiiQ™ Symptom Scale
Evaluation of the duration (defined as the time from the first report of influenza-associated symptoms to resolution) of participant reported influenza-like symptoms as based on the self-reported responses to the RiiQ™ Symptom Scale (scored as 0 = none, 1 = mild, 2 = moderate, and 3 = severe) as presented in the participant eDiary. From the time the participant triggers an Acute Respiratory Infection (ARI) Alert in the eDiary until the ARI episode is resolved (defined as 2 consecutive days where all influenza-associated symptoms on the RiiQ™ Symptom Scale have returned to the same severity level as reported at baseline or lower), the participant will complete the RiiQ™ Symptom Scale in the eDiary for a maximum of 29 days, per ARI episode.
Measured: On Day 1 (pre-dose baseline); and then once daily from the time the participant triggers an ARI Alert in the eDiary until the ARI episode is resolved for a maximum of 29 days per ARI episode, up to 28 weeks after study drug dosing
Trough Plasma Concentration at 24 Weeks (C[trough24w]) Following Administration of CD388
Evaluation of the trough plasma concentration at 24 weeks (C[trough24w]) after study drug dosing. PK parameters will be assessed in approximately 120 participants at designated sites only.
Measured: Based on sampling done at onsite visits on Day 85 (±3 days) and Day 197/EOS (±7 days)
Maximum Plasma Concentration (C[max]) Following Administration of CD388
Evaluation of the maximum plasma concentration (C[max]) after study drug dosing. PK parameters will be assessed in approximately 120 participants at designated sites only.
Measured: At onsite visits done on Day 8, Day 29, and Day 85 (each ±3 days) and on Day 197/EOS (±7 days)
Area Under the Plasma Concentration-Time Curve (AUC) Following Administration of CD388
Evaluation of the area under the plasma concentration-time curve (AUC) after study drug dosing. PK parameters will be assessed in approximately 120 participants at designated sites only.
Measured: At onsite visits done on Day 8, Day 29, and Day 85 (each ±3 days) and on Day 197/EOS (±7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start20 Sep 2024
- Primary completion9 Oct 2025
- Study completion9 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5,071 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609460
- Sponsor's protocol ID
- CD388.SQ.2.05
- Acronym
- NAVIGATE
- Status last verified
- Jun 2026
- First submitted
- 20 Sep 2024
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b Randomized, Double-blind, Placebo-controlled, Multicenter Dose Ranging Study to Evaluate Efficacy and Safety of CD388, a Novel Long-acting Antiviral Conjugate, for the Prevention of Influenza in Subjects Not at Risk for Influenza Complications
- ClinicalTrials.gov ID
- NCT06609460
- Acronym / sponsor ID
- NAVIGATE / CD388.SQ.2.05
- Conditions
- Influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,071 participants (actual)
- Lead sponsor
- Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 9 Oct 2025 (actual)
- Study completion
- 9 Oct 2025 (actual)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness of CD388 in preventing symptomatic laboratory-confirmed influenza infections, as compared to placebo, and to select a dose of CD388 that is effective in preventing the same, when administered as a single dose via 3 subcutaneous (SQ) injections to adult participants in stable health, and to evaluate the safety and tolerability of CD388, as compared to placebo.
Detailed description
This is a Phase 2b, randomized, double-blind, placebo-controlled, parallel-group, multicenter dose selection study to evaluate the efficacy, safety, and tolerability of 3 dose levels of CD388 administered as a single dose via 3 SQ injections in adult participants who are not at risk of developing complications from influenza.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CD388 Low Dose | Experimental | Combination Product: CD388 InjectionParticipants 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 | Combination Product: CD388 InjectionParticipants 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 | Combination Product: CD388 InjectionParticipants 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 | Placebo comparator | Combination Product: PlaceboParticipants are randomized to receive placebo by SQ injection. Participants are randomized at a 1:1:1:1 ratio across the 4 arms. |
Who may qualify
- Ages
- 18 to 63 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Willing and able to provide written informed consent and comply with scheduled visits, laboratory tests, and other study procedures.
- Males and females 18 to less than 64 years of age.
- In the Investigator's clinical judgment, is in stable health at the time of screening and randomization. Participants may not have underlying hematologic, oncologic, renal, autoimmune, and/or cardiopulmonary illnesses or be considered at risk of developing complications from influenza infection per the CDC guidelines (chronic obstructive pulmonary disease [COPD], asthma, immune compromised current cancer [except non-melanomatous skin cancer], or diabetes). Subjects will be included on the basis of medical history and vital signs taken between signing of the informed consent and randomization.
- Body mass index (BMI; calculated as weight in kilograms [kg] divided by height in meters [m] squared) of 18.0 kg/m^2 to 35.0 kg/m^2 (inclusive).
- Women of childbearing potential (WOCBP) must:
Key exclusion criteria (20 listed)
- Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to zanamivir (following administration of inhaled or intravenous formulations), monoclonal antibodies (including crystallizable fragment [Fc] domains), or any of the components of CD388 or placebo.
- Have been diagnosed with influenza (i.e., with medical history [including verbal] of influenza) within the past 6 months prior to randomization.
- Has received the current seasonal influenza vaccine prior to screening or is planning to receive the seasonal vaccine during trial participation.
- Has an acute illness (including acute respiratory illnesses) or body temperature ≥38.0ºC (≥100.4 degrees Fahrenheit [ºF]) within 7 days prior to study drug administration (Note: Enrollment at a later date, subsequent to resolution [within the screening period] is permitted).
- Has had close contact (including household contacts) with someone with laboratory-confirmed influenza or with someone who has been treated with antiviral therapies for influenza within the past 7 days prior to randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD388 InjectionCD388 liquid for injection | Combination product | CD388 High Dose, CD388 Low Dose, CD388 Medium Dose |
| PlaceboPlacebo to match | Combination product | Placebo |
Primary outcome
Percentage of Participants Experiencing Protocol-defined Influenza-like Illness (ILI) Occurring ≥7 Days after and up to 24 Weeks after Administration of Study Drug
Time frame: From Day 8 up to 24 weeks after study drug dosing
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.
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) after Administration of Study Drug
Time frame: From Day 1 through Day 197/End of Study (EOS) after study drug dosing
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.
14 secondary outcomes
Percentage of Participants Experiencing Protocol-defined ILI Occurring ≥7 Days after and up to 28 Weeks after Administration of Study Drug
Time frame: From Day 8 up to 28 weeks after study drug dosing
Percentage of Participants Experiencing Protocol-defined ILI (as in Primary Endpoint 1) Except with a Lower Threshold for New Onset of Fever
Time frame: From Day 8 up to 24 weeks after study drug dosing
Percentage of Participants Experiencing Protocol-defined ILI (as in Primary Endpoint 1) Except the Influenza Infection is Based on the Midturbinate (MT) Swab Result
Time frame: From Day 8 up to 24 weeks after study drug dosing
Percentage of Participants Experiencing an Influenza Infection AND New Onset of Fever AND New Onset of ≥2 Respiratory Symptoms after Administration of Study Drug
Time frame: From Day 8 up to 24 weeks after study drug dosing
Percentage of Participants Experiencing an Influenza Infection AND New Onset of ≥2 Respiratory Symptoms after Administration of Study Drug
Time frame: From Day 8 up to 24 weeks after study drug dosing
Percentage of Participants Experiencing an Influenza Infection AND New Onset of ≥1 Respiratory Symptom AND New Onset of ≥1 Systemic Symptom after Administration of Study Drug
Time frame: From Day 8 up to 24 weeks after study drug dosing
Percentage of Participants Experiencing an Influenza Infection, AND New Onset of ≥2 Respiratory Symptoms, OR ≥1 Respiratory Symptom AND New Onset of ≥1 Systemic Symptom, after Administration of Study Drug
Time frame: From Day 8 up to 24 weeks after study drug dosing
Percentage of Participants Experiencing an Influenza Infection AND New Onset of Fever, AND New Onset of ≥2 Respiratory Symptoms, OR New Onset of ≥1 Respiratory Symptom Plus New Onset of ≥1 Systemic Symptom, after Administration of Study Drug
Time frame: From Day 8 up to 24 weeks after study drug dosing
Severity (as Composite Symptom Score) of Participant Reported Influenza-like Symptoms as Based on the Self-reported Responses to the Respiratory Infection Intensity and Impact Questionnaire (RiiQ™) Symptom Scale
Time frame: On Day 1 (pre-dose baseline); and then once daily from the time the participant triggers an ARI Alert in the eDiary until the ARI episode is resolved for a maximum of 29 days per ARI episode, up to 28 weeks after study drug dosing
Severity (as Area Under the Curve [AUC]) of Participant Reported Influenza-like Symptoms as Based on the Self-reported Responses to the RiiQ™ Symptom Scale
Time frame: On Day 1 (pre-dose baseline); and then once daily from the time the participant triggers an ARI Alert in the eDiary until the ARI episode is resolved for a maximum of 29 days per ARI episode, up to 28 weeks after study drug dosing
Duration (as Time to Symptom Resolution) of Participant Reported Influenza-like Symptoms as Based on the Self-reported Responses to the RiiQ™ Symptom Scale
Time frame: On Day 1 (pre-dose baseline); and then once daily from the time the participant triggers an ARI Alert in the eDiary until the ARI episode is resolved for a maximum of 29 days per ARI episode, up to 28 weeks after study drug dosing
Trough Plasma Concentration at 24 Weeks (C[trough24w]) Following Administration of CD388
Time frame: Based on sampling done at onsite visits on Day 85 (±3 days) and Day 197/EOS (±7 days)
Maximum Plasma Concentration (C[max]) Following Administration of CD388
Time frame: At onsite visits done on Day 8, Day 29, and Day 85 (each ±3 days) and on Day 197/EOS (±7 days)
Area Under the Plasma Concentration-Time Curve (AUC) Following Administration of CD388
Time frame: At onsite visits done on Day 8, Day 29, and Day 85 (each ±3 days) and on Day 197/EOS (±7 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
57 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CD388 Injection in people with Influenza, run by Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 57 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Experiencing Protocol-defined Influenza-like Illness (ILI) Occurring ≥7 Days after and up to 24 Weeks after Administration of Study Drug (time frame: From Day 8 up to 24 weeks after study drug dosing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.