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New treatment option for Healthy Volunteers
Official title A Phase 1 Study of CLYM116 in Normal Healthy Volunteers
ClinicalTrials.gov ID: NCT07248865
What this study is testing
What is CLYM116?
CLYM116 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for healthy volunteers.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This Phase 1, first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CLYM116 in healthy volunteers.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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)
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Brisbane, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brisbane, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.