CD388 for Flu Prevention

(NAVIGATE-2 Trial)

Recruiting at 2 trial locations

Overseen By Head of Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cidara Therapeutics Inc.

Must not be taking: Zanamivir, Monoclonal antibodies

Disqualifiers: Allergy, Acute illness, Unstable condition, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if repeated doses of the experimental drug CD388 are safe and effective for preventing the flu in healthy adults who have already tolerated an initial dose. Researchers seek to assess whether the body produces antibodies against CD388 after yearly doses and to gather more information about the drug's safety and side effects over time. This trial suits healthy individuals who previously participated in a related study and tolerated their initial doses without serious issues. Participants will receive two doses over two years and will be closely monitored for any immune responses or side effects. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants the chance to contribute to important findings on the drug's efficacy.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the study team to understand any potential interactions with the trial drug CD388.

Is there any evidence suggesting that CD388 is likely to be safe for humans?

Research has shown that CD388 is safe for humans. In a study where people were exposed to the flu, CD388 proved safe and effective in preventing flu infections. Participants reported no serious side effects, indicating it as a safe option for flu prevention. CD388 operates independently of the body's immune system, offering protection even to those with weaker immune systems.

In this study, participants who previously took CD388 without serious side effects will receive two more doses. The aim is to determine if repeated doses remain safe and if the drug continues to work without causing immune reactions. The previous good tolerance suggests that CD388 may remain safe with repeated use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

CD388 is unique because it offers a new approach to flu prevention with its targeted mechanism of action. Unlike standard flu vaccines that stimulate the immune system to recognize and fight the virus, CD388 is a monoclonal antibody designed to neutralize the flu virus directly by binding to a specific part of the virus, preventing it from infecting cells. Researchers are excited about CD388 because it is administered as a single subcutaneous injection, which could provide long-lasting protection over a year, potentially reducing the need for annual flu vaccinations. This innovative approach might offer broader and more durable protection, especially for those who are at higher risk or have weaker responses to traditional vaccines.

What evidence suggests that CD388 is effective for flu prevention?

Studies have shown that CD388 effectively prevents the flu. In earlier research, a single 450 mg dose of CD388 provided 76% protection against flu symptoms for 24 weeks. Participants tolerated it well, and it effectively stopped flu confirmed by lab tests. In this trial, participants will receive a single 450 mg dose of CD388 by subcutaneous injection, followed by a repeat dose one year later. These findings suggest that CD388 might offer better protection than some traditional flu vaccines. Overall, the evidence supports CD388 as a promising option for flu prevention. ^{3 4 6 7 8}

Who Is on the Research Team?

Nicole Davarpanah, MD, JD

Principal Investigator

Cidara Therapeutics Inc.

Are You a Good Fit for This Trial?

This trial is for healthy adults who have previously tolerated a dose of the experimental flu drug CD388 without serious side effects. Participants will be given two more doses over two years and monitored for 18 months to ensure safety and study their body's reaction.

Inclusion Criteria

Be willing and able to provide written informed consent and comply with scheduled visits, laboratory tests, and other study procedures

Have a body mass index (BMI) of ≥18 kg/m^2

Must agree to contraception requirements

Exclusion Criteria

Have current or planned participation in another clinical study where study intervention is being administered while participating in this current study

Have a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to zanamivir, monoclonal antibodies, or any of the components of CD388

Have a serious and/or clinically unstable condition, including but not limited to, a psychiatric condition, Alzheimer's disease, or any other condition which in the opinion of the Investigator might lead to hospitalization or death within this study period

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive a single 450 mg dose of CD388 by subcutaneous injection

12 months

Visits on Day 1, Day 29, Day 85, Day 169, and Day 197

Treatment Period 2

Participants receive a repeat single 450 mg dose of CD388 by subcutaneous injection

12 months

Visits on Day 1, Day 29, Day 85, Day 169, and Day 197/End of Study

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• CD388

Trial Overview The study tests the safety of giving repeated annual doses of CD388 to healthy individuals. It also examines how the body processes the drug over time and whether it triggers any immune response, such as producing anti-drug antibodies.

How Is the Trial Designed?

Group I: CD388 Experimental Treatment 1 Intervention

Each participant will receive a single 450 mg dose of CD388 by subcutaneous (SQ) injection followed 1 year later by a repeat single 450 mg dose of CD388 administered by SQ injection.

Who Is Running the Clinical Trial?

Cidara Therapeutics Inc.

Lead Sponsor

Trials

12

Recruited

7,400+

Citations

1. cidara.com cidara.com/news/cidara-therapeutics-announces-positive-topline-results-from-its-phase-2b-navigate-trial-evaluating-cd388-a-non-vaccine-preventative-of-seasonal-influenza/

Cidara Therapeutics Announces Positive Topline Results ... Single doses of 450mg, 300mg and 150mg of CD388 conferred 76%, 61% and 58% protection, respectively, from symptomatic influenza over 24 weeks compared to ...

2. academic.oup.com academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaf465/8276183

Prophylactic Efficacy of CD388, a Novel Drug–Fc Conjugate ... CD388 was well-tolerated and demonstrated prophylactic activity against RT-qPCR–confirmed influenza infection in a human challenge study. The ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05523089

The Effectiveness of CD388 to Prevent Flu in an Influenza ... The purpose of this study is to evaluate the preventative antiviral activity of CD388, as compared to saline placebo, when administered as a single dose to ...

4. cidrap.umn.edu cidrap.umn.edu/influenza-general/experimental-flu-drug-may-protect-better-flu-vaccines-company-data-show

Experimental flu drug may protect better than flu vaccines, ... The drug's prevention efficacy (PE) was 76.1% in the 450-mg group, 61.3% in the 300-mg group, and 57.7% in the 150-mg group.

5. rheumatologyadvisor.com rheumatologyadvisor.com/news/novel-antiviral-gets-breakthrough-tx-status-for-universal-flu-protection/

Novel Antiviral Gets Breakthrough Tx Status for Universal ... Over 24 weeks, statistically significant prevention efficacy (PE) was observed for all 3 doses of CD388 compared with placebo (PE: 150mg: 57.7% ...

6. cidara.com cidara.com/news/cidara-therapeutics-receives-u-s-fda-breakthrough-therapy-designation-for-cd388-in-seasonal-influenza-prevention/

Cidara Therapeutics Receives U.S. FDA Breakthrough ... As a long-acting prophylactic drug, CD388's activity does not rely on an immune response, making it a potential prevention option for high-risk ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06609460

NCT06609460 | Study of CD388 for the Prevention of ... The purpose of this study is to evaluate the effectiveness of CD388 in preventing symptomatic laboratory-confirmed influenza infections, as compared to placebo.

8. clinicaltrialvanguard.com clinicaltrialvanguard.com/news/cidara-presents-late-breaking-phase-2-cd388-clinical-data/

Cidara Presents Late-Breaking Phase 2 CD388 Clinical Data CD388 is a drug–Fc conjugate designed for single-dose, season-long protection against influenza A and B via direct viral inhibition. If the late ...