Study of CD388 for the Prevention of Influenza in Subjects Not at Risk for Influenza Complications (NCT06609460) | Clinical Trial Compass
CompletedPhase 2
Study of CD388 for the Prevention of Influenza in Subjects Not at Risk for Influenza Complications
United States, United Kingdom5,071 participantsStarted 2024-09-20
Plain-language 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 participants in stable health, and to evaluate the safety and tolerability of CD388, as compared to placebo.
Who can participate
Age range
18 Years – 63 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants Experiencing Protocol-defined Influenza-like Illness (ILI) Occurring ≥7 Days after and up to 24 Weeks after Administration of Study Drug
Timeframe: From Day 8 up to 24 weeks after study drug dosing
2
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) after Administration of Study Drug
Timeframe: From Day 1 through Day 197/End of Study (EOS) after study drug dosing
Trial details
NCT IDNCT06609460
SponsorCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
. Have a negative pregnancy test (beta-human chorionic gonadotropin \[β-hCG\]) at screening, AND
. 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.
. 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.
Exclusion criteria
. 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.
. 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.