CD388 Injection for Flu Prevention

(NAVIGATE Trial)

Recruiting at 56 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

5000 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug CD388 Injection for flu prevention?

Research on similar treatments shows that using adjuvants (substances that enhance the body's immune response to an antigen) can improve the effectiveness of flu vaccines. For example, the use of adjuvants like CpG 1018 in vaccines has been shown to provide strong protection against flu in animal studies. ^{1 2 3 4 5}

How is the drug CD388 unique for flu prevention?

CD388 is unique because it targets CD38, a molecule involved in immune cell activation and signaling, which is not a common target for flu prevention. This approach may offer a novel mechanism compared to traditional flu vaccines that typically target viral proteins. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Nicole Davarpanah, MD, JD

Principal Investigator

Cidara Therapeutics Inc.

Eligibility Criteria

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

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

A phase I randomized, double-blind, controlled trial of 2009 influenza A (H1N1) inactivated monovalent vaccines with different adjuvant systems. [2013]

2. Netherlands pubmed.ncbi.nlm.nih.gov

The universal influenza vaccine M2e-HBc administered intranasally in combination with the adjuvant CTA1-DD provides complete protection. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A CpG 1018 adjuvanted neuraminidase vaccine provides robust protection from influenza virus challenge in mice. [2022]

4. China pubmed.ncbi.nlm.nih.gov

Intranasal Immunization Using CTA1-DD as a Mucosal Adjuvant for an Inactivated Influenza Vaccine. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Injectable Excipients as Novel Influenza Vaccine Adjuvants. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Safety, tolerability, pharmacokinetics and pharmacodynamics of the anti-CD38 cytolytic antibody TAK-079 in healthy subjects. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Attenuating regulatory T cell induction by TLR agonists through inhibition of p38 MAPK signaling in dendritic cells enhances their efficacy as vaccine adjuvants and cancer immunotherapeutics. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Antigen-induced clustering of surface CD38 and recruitment of intracellular CD38 to the immunologic synapse. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Targeting CD38 in Neoplasms and Non-Cancer Diseases. [2022]

10. England pubmed.ncbi.nlm.nih.gov

The role of CD38 in HIV infection. [2021]