Normal Healthy Volunteer (NHV) refers to a participant without the target disease who enrolls in a clinical study, most commonly in Phase 1 research.
NHVs are used to characterize safety, tolerability, pharmacokinetics, and sometimes pharmacodynamics without confounding disease effects. Because NHVs do not expect therapeutic benefit, risk minimization, consent clarity, and safety monitoring are especially important. Eligibility criteria and screening assessments are designed to protect volunteers and reduce unpredictable risk. NHV studies generate foundational exposure and safety data that inform dose selection and development strategy.