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

NCT04578028 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2021-12-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ONO-2808

Investigational drug

DRUG

Placebo

Placebo drug

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Ono Pharmaceutical Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Pablo F Soto, MD,MSc, PhD · Parexel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04578028 on ClinicalTrials.gov