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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-12

Study Completion Date

2021-05-25

Brief Summary

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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.

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Detailed Description

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To investigate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity when ONO-4685 is administered by single-dose intravenous continuous infusion in Japanese and Caucasian healthy adult male subjects. In addition, in Japanese healthy adult male subjects, to investigate dosing condition of Keyhole limpet hemocyanin (KLH) and to investigate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity when ONO-4685 is administered by single-dose intravenous continuous infusion after treating with KLH.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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ONO-4685 (PartA, D)

Group Type EXPERIMENTAL

ONO-4685

Intervention Type BIOLOGICAL

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

Placebo (PartA, D)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

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

KLH+placebo (Part B)

Group Type EXPERIMENTAL

KLH

Intervention Type BIOLOGICAL

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

KLH+ONO-4685 (PartC)

Group Type EXPERIMENTAL

KLH, ONO-4685

Intervention Type BIOLOGICAL

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.

KLH+placebo (PartC)

Group Type EXPERIMENTAL

KLH, placebo

Intervention Type BIOLOGICAL

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.

Interventions

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ONO-4685

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

Intervention Type BIOLOGICAL

Placebo

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

Intervention Type BIOLOGICAL

KLH

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

Intervention Type 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.

Intervention Type 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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Japanese healthy adult male subjects (PartA, B, and C)
* Caucasian healthy adult male subjects (Part D)
* Age (at the time of informed consent): ≥20 yeas, ≤ 45 yeas
* Body weight (at the time of screening test): ≥50 kg

Exclusion Criteria

* Subjects who are on a treatment for or with a history of respiratory, cardiovascular, psychiatric, neurologic, gastrointestinal, immunologic, hepatic, renal, hematopoietic or endocrine and/or other disease.
* Subjects with current or with a history of severe allergy to drugs or foods
* Subjects with current or with a history of drug or alcohol abuse

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes