RecruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Safety and Efficacy of CD388 for Prevention of Influenza

This research study is looking into a new medicine called CD388. We want to find out if CD388 can prevent people from getting flu infections that are confirmed by lab tests. The study is for adults and teenagers (aged 12 and older) who have a higher chance of developing serious problems if they catch the flu. Some participants will receive the CD388 injection, while others will receive a placebo, which looks identical but contains no active medicine. This allows us to compare the effects of CD388. We'll also be carefully checking for any side effects to make sure CD388 is safe and well-tolerated. This is a crucial step in developing new ways to protect vulnerable people from the flu.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Enrolment target

7,500

Start

25 Sep 2025

Estimated completion

01 Jan 2027

Influenza

What is this study about?

This research is a Phase 3 study, which means it’s one of the final steps in testing a new medicine before it might become widely available. The study aims to understand if a new treatment called CD388 can stop people from getting the flu. We’re particularly interested in helping people aged 12 and above who might be more likely to get very ill or have complications if they catch the flu.

Participants in the study will be randomly assigned to receive either the active medicine, CD388, or a placebo. A placebo is a 'dummy' treatment that looks exactly like the real medicine but has no active ingredients. This is a common and important way to test new medicines, as it helps us understand if any improvements are genuinely due to the medicine itself, rather than other factors. Neither you nor your study doctor will know whether you are receiving CD388 or the placebo, ensuring the results are as fair and unbiased as possible.

The main goals are to see how effective CD388 is at preventing flu infections that are confirmed by lab tests, and to thoroughly check its safety. We'll be looking out for any side effects and how well people tolerate the treatment compared to the placebo. The information gathered from this study will help us decide if CD388 could be a valuable new option for preventing flu.

Key takeaways

This study is testing a new medicine called CD388 to prevent flu.
It's for people aged 12 and above who are at higher risk of serious flu.
Participants will receive either CD388 or a dummy treatment (placebo).
The study aims to check how well CD388 works and if it's safe.
Your participation could help develop new flu prevention methods.

Who may be eligible?

To join this study, you need to be at least 12 years old. You must also be generally healthy and weigh at least 40 kilograms (about 6 stone 4 pounds) with a Body Mass Index (BMI) of 18 or above. Before you start, we'll check that you don't currently have flu or COVID-19.

It's important that you understand what the study involves and are able to follow the study instructions, including completing questionnaires. We also need to make sure you've been medically stable recently, meaning no new serious health issues or hospital stays in the two months leading up to the study.

If you're a woman who could become pregnant, you'll need to agree to use effective contraception during the study. The study team will discuss all these requirements with you in detail to make sure this study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 12 years old or older?
Do you weigh at least 40 kg (about 6 stone 4 lbs)?
Have you been generally stable medically for the last two months?
Could you attend appointments and complete an eDiary?
If female and able to become pregnant, are you willing to use effective contraception?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening visit to check if you're suitable. This will include checks for flu and COVID-19, and a review of your medical history. If you meet the criteria, you will receive a single dose of the study medicine (either CD388 or placebo) given as three injections just under the skin. You won't know which one you're getting, and neither will your study doctor.

Throughout the study, you'll have regular check-ups to monitor your health and any potential side effects. You'll also be asked to complete an electronic diary using a smartphone, tablet, or computer to record any symptoms or changes you experience. The total length of your participation in the study will depend on how long we need to watch for flu infections and track your health, but it will involve several visits over a period of time.

Potential risks and benefits

There's no guarantee that participating will benefit you directly, but your involvement will provide valuable information that could help develop new ways to prevent flu for others in the future. As with any medicine or injection, there's a chance of side effects, such as soreness at the injection site or other reactions. The study team will closely monitor you and tell you about any known risks. You can withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (181)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Pinnacle Research Group, LLC
Verified postcode
Anniston, United States· Active not recruiting
Cullman Clinical Trials
Verified postcode
Cullman, United States· Active not recruiting
HOPE Research Institute
Verified postcode
Glendale, United States· Active not recruiting
Desert Clinical Research, LLC / Avacare
Verified postcode
Mesa, United States· Active not recruiting
Foothills Research Center / Avacare
Verified postcode
Phoenix, United States· Active not recruiting
Fiel Family and Sports Medicine / Avacare
Verified postcode
Tempe, United States· Active not recruiting
HOPE Research Institute
Verified postcode
Tempe, United States· Active not recruiting
Arizona Clinical Trials
Verified postcode
Tucson, United States· Active not recruiting
Del Sol Research Management, LLC
Verified postcode
Tucson, United States· Active not recruiting
Triallogix Medical Corporation
Verified postcode
Fullerton, United States· Active not recruiting
National Institute of Clinical Research, Inc.
Verified postcode
Garden Grove, United States· Active not recruiting
Eximia Research-CA, LLC
Verified postcode
La Mesa, United States· Active not recruiting

Common questions

What is CD388?

CD388 is a new medicine being tested to see if it can prevent flu infections. It's currently in the research phase and not available as a standard treatment.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the real medicine but doesn't contain any active ingredients. It's used to fairly compare the effects of the new medicine.

Why are some people getting a placebo?

Using a placebo helps researchers determine if the effects seen are truly due to the study medicine, rather than other factors. This is a standard and important part of medical research.

Will I get the flu vaccine if I join this study?

The study will provide specific guidance regarding flu vaccinations. Please discuss this with the study team if you are considering participating.

How long will I be in the study?

Participation involves several visits over a period of time, which the study team will explain in detail. The total duration depends on how long we need to monitor for flu infections and track your health.

How to find out more

Head of Clinical Operations

clinicaltrialinfo@cidara.com 858-888-7868 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.