๐ฌIn plain words
What the trial is, and whether it could suit you
This Phase 1, first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CLYM116 in healthy volunteers.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Healthy adult males and females aged 18-60 years, inclusive
* Body mass index (BMI) between 18 and 32 kg/mยฒ 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)
Nucleus Network Brisbane
Brisbane, Australia
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.