New drug CLYM116 enters first human safety trial
NCT ID NCT07248865
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests the safety of a new drug, CLYM116, in 48 healthy adults aged 18-60. Participants receive either the drug or a placebo by injection, and researchers monitor for side effects and how the drug moves through the body. The study is not designed to treat any disease, but to gather essential safety data before testing in patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CLYM116
- What could go wrong
- This is a very early Phase 1 study in healthy people, so it cannot show if the drug works for any disease. The main goal is safety, not effectiveness.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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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: * Healthy adult males and females aged 18-60 years, inclusive * Body mass index (BMI) between 18 and 32 kg/m² and weight between 45 and 110 kg * Clinically normal medical history, physical exam, ECG, and laboratory results (or abnormalities deemed not clinically significant) * Willing and able to comply with study procedures and provide informed consent * Women of childbearing potential must use highly effective contraception and have negative pregnancy tests * Men must use contraception and refrain from sperm donation for 4 months post-dose * Completion of COVID-19 vaccination according to local guidelines, as well as influenza vaccination (within 12 months) Exclusion Criteria: * Prior treatment with investigational drugs within 30 days or 5 half-lives * Previous or current hypogammaglobulinemia * Current presence of allergic reactions considered clinically significant * Positive tests for HIV, hepatitis B/C, syphilis, or tuberculosis * Tobacco use (\>2 cigarettes/day), alcohol abuse, or drug abuse * Recent live vaccination (within 21 days) or any non-live vaccine (within 14 days)
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Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Nucleus Network Brisbane
RECRUITINGBrisbane, 4006, Australia
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