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New flu pill passes first safety hurdle in small human study

NCT ID NCT05202379

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tested a new oral drug called CC-42344 in 80 healthy adults to see if it is safe and how the body processes it. The drug is designed to stop the influenza A virus from multiplying. The study did not treat actual flu patients, but the results will help decide whether to test it further in people with the flu.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CC-42344 (an oral capsule that aims to stop the flu virus from multiplying)
What this could lead to
If safe and effective in later trials, this drug could become a new treatment option for influenza A, helping reduce symptoms and shorten illness.
What could go wrong
This is a very early Phase 1 study focused on safety and dosing in healthy people, not on treating flu. Many drugs fail in later stages, and it may not prove effective against the virus.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

80 people

The number who actually took part.

Started

Feb 2022

Finished

Mar 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria (main): * Healthy males or healthy, non-pregnant, non-lactating females * Body weight of at least 50 kg * Body mass index between ≥18.0 and ≤32.0 kg/m2 * Good state of health (mentally and physically) * Negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test, if required and per site policy Exclusion Criteria (main): * Have received any investigational drug in a clinical research study within the previous 30 days before screening * Have received any vaccine within 7 days prior to randomization * History of any drug or alcohol abuse in the past 2 years * Females of childbearing potential who are pregnant or lactating or planning to become pregnant during the study * Clinically significant abnormal biochemistry, hematology, coagulation, or urinalysis as judged by the investigator

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Linear Clinical Research

    Nedlands, Western Australia, 6009, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.