Number of Subjects in Phase 1 Clinical Trial

Question

In Phase 1 clinical trials, how many healthy volunteers are typically enrolled?

Select an answer

In Phase 1 clinical trials, how many healthy volunteers are typically enrolled?

  1. 25–50 — Correct Answer
  2. 100–200
  3. 500–1000
  4. >1000
Explanation:
Correct Answer: 25–50

Phase 1 clinical trials involve a small number — 25–50 healthy volunteers — to establish dosage effects and probable limits of safe clinical dosage range.

Phases of Clinical Trials
  • Phase 1: 25–50 healthy volunteers; open (non-blind); determines safe dose range; pharmacokinetics measured.
  • Phase 2: 100–200 patients with target disease; single-blind; evaluates efficacy.
  • Phase 3: Thousands of patients; double-blind, crossover; confirms safety and efficacy.
  • Phase 4: Post-marketing surveillance; no fixed duration; monitors for rare adverse effects in real-world conditions.

📚 About this Topic — Veterinary Pharmacology and Toxicology

This multiple choice question is from Veterinary Pharmacology and Toxicology, Veterinary Science. It has 4 options with a detailed explanation of the correct answer. Practice more MCQs from Veterinary Pharmacology and Toxicology to strengthen your preparation.

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