New flu pill passes first safety hurdle in small human study
NCT ID NCT05202379
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 Hide 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
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Other studies related to the condition(s) this trial covers.
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