CD388 Injection for Flu Prevention

(NAVIGATE Trial)

Recruiting at 56 trial locations

Overseen By Head of Clinical Operations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Cidara Therapeutics Inc.

Prior Safety Data

Trial Summary

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

I am between 18 and 63 years old.

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.

Treatment Details

Interventions

• CD388 (Virus Therapy)

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+