Clin2
NCT05318534Possibly a fitRecruiting

Testing a new medicine for Cold Agglutinin Disease

First in Man Study to Evaluate Initial Safety

Part of Blood & lymphatic clinical trials.

This Phase 1 study checks whether an investigational medicine is safe and tolerable, and how the body processes it. For people with Cold Agglutinin Disease, it also looks at early blood markers of whether the disease responds.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 1
Enrollment
70 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You must be age 18–65 if you’re in the healthy-subject groups (otherwise at least 18).
  • You must be non-pregnant and not breastfeeding; you must agree to use contraception if you could become pregnant.
  • You must meet the study body size limits (BMI 18–32 and weight >50 kg for the healthy groups).
  • You must have had a meningococcal ACWY vaccine within the past 5 years (or at least 14 days before starting).
  • If you have Cold Agglutinin Disease (CAD), you must have a confirmed diagnosis, and certain blood tests must fit the study ranges.
  • You must be able to understand the study and sign informed consent.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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