drugset / Trial / NCT04578028

A First in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of ONO-2808-01 in Healthy Participants

NCT04578028 ↗

Phase 1 Completed 94 enrolled Ono Pharmaceutical Co., Ltd. Parexel · collab
RandomizedSequentialDouble-blindTreatment

Summary

This is a first in human study to determine the safety, tolerability and pharmacokinetics of ONO-2808 in healthy adult participants. The study will be conducted in 3 parts: Part A, a single-ascending dose part with an assessment of the potential food effects in non-Japanese adult participants; Part B, a single dose part to assess the effect of age in non-Japanese elderly participants; and Part C, a multiple-ascending dose part with ONO-2808 administered to healthy subjects.

Timeline

Start
2020-08-19
Primary completion
2021-08-26
Completion
2021-10-07

Drugs

EvaluationDrugModalityDoseRoute
Subject ONO-2808 Unknown — Oral