drugset / Trial / NCT04887038

First-in-Human Study of SRT-015 in Healthy Subjects.

NCT04887038 ↗

Phase 1 Completed 81 enrolled Syneos Health
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is phase 1 first-in-human trial evaluating SRT-015 to assess safety, tolerability and pharmacokinetics. This study will be conducted in 3 parts - SAD, MAD and Food Effect with target of 96 healthy volunteers. This will be a single center, Phase 1, randomized, double-blind, placebo controlled, SAD and MAD study of dose escalation cohorts evaluating administration of SRT-015 or placebo. Additionally, PK will be assessed in fed and fasting states.

Timeline

Start
2021-05-03
Primary completion
2022-02-28
Completion
2022-02-28

Drugs

EvaluationDrugModalityDoseRoute
Comparator SRT-015 Unknown — Oral