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A Study to Evaluate the Safety and Efficacy of CD388 for Prevention of Influenza | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

A Study to Evaluate the Safety and Efficacy of CD388 for Prevention of Influenza

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of CD388, a Novel Long-Acting Antiviral Conjugate, for the Prevention of Influenza in Adults and Adolescents at Higher Risk of Developing Influenza Complications

NCT07159763•Cidara Therapeutics Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate how well CD388 works in preventing symptomatic laboratory-confirmed influenza infections, as compared to placebo, when given as a single dose via 3 subcutaneous (SQ) injections to adult and adolescent participants who are at higher risk of developing influenza complications, and to evaluate the safety and tolerability of CD388, as compared to placebo.

Detailed Description

This is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy, safety, and tolerability of CD388 administered as a single dose via 3 SQ injections in adult and adolescent participants who are at higher risk of developing complications from influenza.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

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 protocol-related procedures, including screening evaluations. For participants under the legal age of consent as defined by local regulations, the parent(s) or legal guardian(s) may be required to give their signed written informed consent and participants may sign an assent form as specified by local law.
•3. Has negative rapid antigen tests for influenza and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) prior to dosing at Day 1.
•4. Weight is ≥ 40 kilograms (kg) at screening.
•5. Body Mass Index (BMI; calculated as weight in kg divided by height in meters \[m\] squared)) is ≥ 18 kg/m\^2 at screening.
•6. In the opinion of the Investigator, must be able to comply with the requirements of the protocol and be able to read, understand, and complete questionnaires in the electronic diary (eDiary), work with smartphones/tablets/computers (if applicable, with assistance by a caregiver, surrogate, or legally authorized representative), 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.
•7. Must be assessed by the Investigator as medically stable and not requiring significant change in maintenance therapy and has not been hospitalized for worsening disease or any significant medical event during the 2 months before screening
•8. Must agree to the following contraception requirements:
•a. Females of childbearing potential must use 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 agree to remain on a highly effective method from Day 1 until 32 weeks after study intervention administration, the end of relevant systemic exposure. Note: 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.
•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.
+32 more criteria

Exclusion Criteria

•1. A female who is pregnant or lactating.
•2. 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.
•3. Has been diagnosed with influenza (i.e., with medical history \[including verbal\] of influenza) within 6 months prior to randomization.
•4. Has received the current seasonal inactivated influenza vaccine or live attenuated influenza vaccine within the 14 days prior to dosing on Day 1. (NOTE: Participant may have received recombinant influenza vaccine up to the day of dosing on Day 1.)
•5. Has an acute (time-limited) or febrile (temperature ≥38.0 degrees Celsius \[ºC\] \[≥100.4 degrees Fahrenheit {ºF}\]) illness within 7 days prior to planned dosing on Day 1.
•6. Has had close contact (including household contact) with someone with laboratory-confirmed influenza or SARS-CoV-2 or with someone who has been treated with antiviral therapies for influenza or SARS-CoV-2 within the 7 days prior to randomization.
•7. Has a clinically unstable condition including, but not limited to, a psychiatric condition, including recent (within the past year) or active suicidal ideation/behavior, or any other condition for which, in the opinion of the Investigator, may lead to hospitalization or death within the study period and that suggests that study enrollment would not be in the participant's best interest and/or that could prevent, confound, or limit the protocol-specified assessments.
•8. Has any history of alcohol or drug abuse that, in the opinion of the Investigator, would adversely impact the conduct of the study.
•9. Had major surgery (e.g., major cardiac, pulmonary or abdominal operation) 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.
•10. Has severe CKD (equivalent to an eGFR less than 30 mL/min/1.73 m\^2 as calculated by CKD-EPI equation for adults or the CKiD U25 equation for adolescents), or is receiving hemodialysis.
+8 more criteria

Locations (150)

Pinnacle Research Group, LLC

Anniston, Alabama, United States

Cullman Clinical Trials

Cullman, Alabama, United States

HOPE Research Institute

Glendale, Arizona, United States

Desert Clinical Research, LLC / Avacare

Mesa, Arizona, United States

Foothills Research Center / Avacare

Phoenix, Arizona, United States

Fiel Family and Sports Medicine / Avacare

Tempe, Arizona, United States

HOPE Research Institute

Tempe, Arizona, United States

Arizona Clinical Trials

Tucson, Arizona, United States

Del Sol Research Management, LLC

Tucson, Arizona, United States

Triallogix Medical Corporation

Fullerton, California, United States

Key Dates

Start Date

September 25, 2025

Primary Completion Date

January 1, 2027

Completion Date

January 1, 2027

Last Updated

February 23, 2026

Enrollment

7,500

ESTIMATED participants

Conditions

Influenza

Interventions

CD388 Injection

COMBINATION_PRODUCT

Placebo

COMBINATION_PRODUCT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Safety and Efficacy of CD388 for Prevention of Influenza

Inclusion Criteria

Exclusion Criteria

Phase 1/2 Study of a Plant-Based Seasonal Recombinant Trivalent VLP Influenza Vaccine

A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts

Dime La VerDAD: Verify, Debunk, and Disseminate

Clinical Outcomes and Pharmacotherapy Effectiveness in the VA Health Care System (COPE-VA)

Effectiveness and Implementation of a National Guideline for Acute Respiratory Tract Infections to Reduce Antibiotic Prescribing in Swiss Primary Care

Administration of the Nasal Influenza Vaccine to Children in Daycare or at a Healthcare Facility