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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 weeks3 visits

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)

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

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