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Phase 1CompletedGeroscience intervention

A Single and Multiple Dose Study of AMAZ-02 to Evaluate Safety and Pharmacokinetics in Elderly Subjects

A Single (Part A) and Multiple (Part B) Dose Study of AMAZ-02, a Food Derived Ingredient to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Profile in Healthy Elderly Subjects

Sponsor
Amazentis SA (Industry)
Enrolment
60 enrolled
Conditions
Aging; Mitochondrial Dysfunction; Muscle Function
Interventions
Mitopure
Ages
adults, older adults
Registry
NCT02655393

Full record on ClinicalTrials.gov

From the registry

Part A: The study is a double-blind, randomized, single ascending doses, study in 24 healthy elderly male and female volunteers. Each subject will be randomized for two subsequent doses in three cohorts. Part B: The study is a double-blind, randomized, multiple ascending doses study in 36 healthy elderly male and female volunteers. Subjects will be randomized to receive study product or placebo for 28 days.

Primary outcomes

  • Number of subjects with adverse events

History

  1. Last registry update

  2. Study completion

  3. Primary completion

  4. Started

  5. Registered