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Virus Therapy

CD388 Injection for Flu Prevention (NAVIGATE Trial)

Phase 2
Recruiting
Research Sponsored by Cidara Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males and females 18 to less than 64 years of age
In stable health at the time of screening and randomization, without underlying hematologic, oncologic, renal, autoimmune, and/or cardiopulmonary illnesses or considered at risk of developing complications from influenza infection per CDC guidelines
Must not have
Presence of serious and/or clinically unstable conditions
Contraindication to specific medical procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at onsite visits done on day 8, day 29, and day 85 (each ±3 days) and on day 197/eos (±7 days)

Summary

This trial aims to find the right amount of CD388 that can prevent the flu compared to a placebo. The study will involve giving three injections under the skin to healthy adults and will also look at the

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed, the safety and tolerability of CD388 compared to a placebo will be assessed. Side effects may include typical reactions to injections such as pain or swelling at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 63 years old.
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I am in stable health without serious illnesses that could worsen with the flu.
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I am not pregnant and use birth control.
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I agree not to donate or freeze my eggs for assisted reproduction.
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I am a male and agree to use a condom and not donate sperm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any serious or unstable health conditions.
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I cannot undergo certain medical procedures due to health risks.
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I have not been sick or had a fever in the last week.
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I have not taken any prohibited medications before starting the study drug.
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I have not had major surgery recently and do not plan any during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at onsite visits done on day 8, day 29, and day 85 (each ±3 days) and on day 197/eos (±7 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at onsite visits done on day 8, day 29, and day 85 (each ±3 days) and on day 197/eos (±7 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) after Administration of Study Drug
Percentage of Participants Experiencing Adjudicated Protocol-defined Influenza-like Illness (ILI) Occurring ≥7 Days after and up to 24 Weeks after Administration of Study Drug
Secondary study objectives
Area Under the Plasma Concentration-Time Curve (AUC) Following Administration of CD388
Duration (as Time to Symptom Resolution) of Participant Reported Influenza-like Symptoms as Based on the Self-reported Responses to the RiiQ™ Symptom Scale
Maximum Plasma Concentration (C[max]) Following Administration of CD388
+9 more

Side effects data

From 2023 Phase 1 trial • 28 Patients • NCT05619536
29%
Fatigue
14%
Influenza like illness
14%
Constipation
14%
Headache
14%
Asymptomatic COVID-19
14%
COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
50 mg CD388
Pooled Placebo
450 mg CD388
150 mg CD388

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: CD388 Medium DoseExperimental Treatment1 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 DoseExperimental Treatment1 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 DoseExperimental Treatment1 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: PlaceboPlacebo Group1 Intervention
Participants are randomized to receive placebo by SQ injection. Participants are randomized at a 1:1:1:1 ratio across the 4 arms.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CD388 Injection
2022
Completed Phase 1
~110

Find a Location

Who is running the clinical trial?

Cidara Therapeutics Inc.Lead Sponsor
11 Previous Clinical Trials
2,385 Total Patients Enrolled
Taylor Sandison, MD, MPHStudy DirectorCidara Therapeutics Inc.
2 Previous Clinical Trials
799 Total Patients Enrolled
~3333 spots leftby Sep 2025
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