CLYM116 in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

CLYM116 is a humanized monoclonal antibody that selectively binds APRIL, a protein involved in B-cell activity. This is a first-in-human, randomized, double-blind, placebo-controlled, single-center Phase 1 study enrolling up to 48 healthy volunteers across up to five dosing cohorts. The study will collect safety, tolerability, pharmacokinetic, pharmacodynamic, and immunogenicity data following administration of CLYM116 or placebo. Participants will undergo screening, planned dosing and detailed clinical and laboratory monitoring with scheduled follow-up visits.

Why it matters

Who can join: the full rules

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)

Where it's running

• Nucleus Network Brisbane
  Brisbane, Australia Recruiting

Study contacts

• Study coordinator: Climb Bio Study Director
• Email: clinicaltrials@climbbio.com
• Phone: +1 866 857 2596

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.