CD388 Injection for Flu Prevention

(NAVIGATE Trial)

No longer recruiting at 57 trial locations

Overseen By Head of Clinical Operations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Cidara Therapeutics Inc.

Must not be taking: Antivirals, Monoclonal antibodies

Disqualifiers: Influenza, COVID-19, Unstable conditions, others

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

Compensation: Varies

Number of Visits: 9

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CD388, an experimental injection, to compare its flu prevention effectiveness against a placebo. Researchers aim to determine the optimal dose of CD388 that effectively prevents flu infections when administered as three small injections under the skin. Individuals in stable health who have not recently had the flu or a flu vaccine may be suitable candidates for this study. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, you should discuss your medications with the study team to ensure they don't interfere with the trial.

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

Research has shown that CD388 was safe in earlier studies. Participants who received a single dose of CD388 tolerated it well, and researchers tested different doses to assess their effectiveness in flu prevention. These studies did not identify any major safety issues.

While not all side effects are listed, the progression of CD388 in trials suggests it has not caused serious problems that would halt further testing. The study aims to ensure CD388 is safe and effective in preventing the flu, with participant safety as a top priority. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about CD388 because it offers a fresh approach to flu prevention. Unlike traditional flu vaccines that stimulate the immune system to recognize the virus, CD388 works by potentially blocking the virus from entering cells in the first place. This unique mechanism of action could offer protection against a broader range of flu strains, which is a major leap forward from current vaccines that need to be updated annually. Additionally, CD388 is delivered via a simple subcutaneous injection, which could make administration easier and more accessible for patients.

What evidence suggests that this trial's treatments could be effective for flu prevention?

Research has shown that CD388 is promising for flu prevention. In earlier studies, a single dose of CD388 significantly reduced flu symptoms. Specifically, doses of 150mg, 300mg, and 450mg provided 58%, 61%, and 76% protection, respectively, over about six months. Higher doses appear to offer better protection. The treatment was well-tolerated, with no serious side effects. These findings suggest CD388 could be an effective tool in preventing the flu. ^{1 2 3 5 6}

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 are not at high risk of complications from the flu. Participants will receive a single dose of CD388 or a placebo to test its effectiveness in preventing influenza.

Inclusion Criteria

Body mass index (BMI) of 18.0 kg/m^2 to 35.0 kg/m^2

Must be able to read, understand, and complete questionnaires in the electronic diary, work with smartphones/tablets/computers, and adhere to study protocol

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

Exclusion Criteria

I do not have any serious or unstable health conditions.

I have been in close contact with someone who has flu or COVID-19 recently.

I have not donated blood recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of CD388 via 3 subcutaneous injections

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 weeks

Multiple visits (in-person and virtual) including Day 8, Day 29, Day 85, and Day 197

What Are the Treatments Tested in This Trial?

Interventions

• CD388

Trial Overview

The study is testing CD388, given as three subcutaneous injections in one dose, against a placebo to see if it can prevent symptomatic lab-confirmed flu infections.

How Is the Trial Designed?

Group I: CD388 Medium Dose Experimental Treatment 1 Intervention

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.

Group II: CD388 Low Dose Experimental Treatment 1 Intervention

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.

Group III: CD388 High Dose Experimental Treatment 1 Intervention

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.

Group IV: Placebo Placebo Group 1 Intervention

Participants are randomized to receive placebo by SQ injection. Participants are randomized at a 1:1:1:1 ratio across the 4 arms.

Who Is Running the Clinical Trial?

Cidara Therapeutics Inc.

Lead Sponsor

Trials

12

Recruited

7,400+

Published Research Related to This Trial

CD38 is a promising target for anticancer therapy, particularly in treating multiple myeloma and immunoglobulin light-chain amyloidosis, with several anti-CD38 antibodies like daratumumab and isatuximab already approved by the FDA.

Beyond cancer, CD38 is implicated in various diseases, including autoimmune disorders and viral infections, suggesting its potential as a therapeutic target and biomarker in conditions like transplant rejection and systemic lupus erythematosus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting CD38 in Neoplasms and Non-Cancer Diseases. Szlasa, W., Czarny, J., Sauer, N., et al.[2022]

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.

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, ...

Single doses of 150 milligrams (mg), 300 mg, and 450 mg provided 58%, 61%, and 76% protection from symptomatic flu, respectively, for about 6 ...

3.

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.

4.

academic.oup.com

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

Prophylactic Efficacy of CD388, a Novel Drug–Fc Conjugate ...

Conclusions. CD388 was well-tolerated and demonstrated prophylactic activity against RT-qPCR–confirmed influenza infection in a human challenge ...

5.

vaccineadvisor.com

vaccineadvisor.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.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10678303/

2514. Single Ascending Dose Safety, Tolerability, and ...

Nonclinical studies have shown CD388 was effective prophylactically against a wide range of seasonal and pandemic influenza A and B strains in ...