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Single Ascending Dose Study to Assess the Safety, Tolerability, PK and PD of ONO-4685 in Japanese and Caucasian Healthy Adult Male Subjects

NCT04079062 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2024-05-03

No results posted yet for this study

Summary

To investigate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity in Japanese and Caucasian healthy adult male subjects when ONO-4685 is administered as a single-dose by intravenous infusion.

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

ONO-4685

Single ascending dose of ONO-4685 will be administered by intravenous continuous infusion at the designated speed.

BIOLOGICAL

Placebo

Placebo will be administered by intravenous continuous infusion at the designated speed.

BIOLOGICAL

KLH

KLH 1 mg per dose will be subcutaneously administered. In addition, all subjects will be administered placebo after KLH administration.

BIOLOGICAL

KLH, ONO-4685

Part C will be conducted in a study design that ONO-4685 will be administered within the dose range, for which the safety has been confirmed in Part A, after administering KLH in the dose regimens selected according to the investigation result in Part B.

BIOLOGICAL

KLH, placebo

Part C will be conducted in a study design that placebo will be administered within the dose range, for which the safety has been confirmed in Part A, after administering KLH in the dose resimens selected according to the investigation result in Part B.

Sponsors & Collaborators

  • Ono Pharmaceutical Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Junichiro Manako · Ono Pharmaceutical Co. Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-12
Primary Completion
2021-05-25
Completion
2021-05-25

Countries

  • Japan

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Entities

Drugs

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 NCT04079062 on ClinicalTrials.gov