Clinical Trial Execution (Phases I-IV)

Usahihi Therapeutics is dedicated to executing each phase of clinical trials with precision and care. Phase I trials focus on safety, dosage, and pharmacokinetics, testing on a small group of healthy volunteers or patients. In Phase II, we assess the efficacy and side effects in a larger group, dividing the trial into dose-finding and efficacy evaluation. Phase III includes pivotal trials with large-scale studies comparing the investigational drug to existing treatments, and Phase IV post-marketing surveillance monitors long-term safety and effectiveness in real-world settings.

Clinical Trial Phases:

• Phase I – First-in-Human Trials
  • Conducted on a small number (20–100) of healthy volunteers or patients.
  • Evaluate safety, dosage, and pharmacokinetics.
• Phase II – Proof-of-Concept Trials
  • Conducted on 100–500 patients to assess efficacy and side effects.
  • Often divided into Phase IIa (dose-finding) and Phase IIb (efficacy evaluation).
• Phase III – Pivotal Trials
  • Large-scale studies (500–3000 patients) across multiple locations.
  • Compares the investigational drug to existing treatments or placebo.
  • Collects extensive safety and efficacy data for regulatory approval.
• Phase IV – Post-Marketing Surveillance
  • Conducted after FDA or EMA approval.
  • Monitors long-term effectiveness, safety, and adverse effects in real-world settings.