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

Ono Pharmaceutical Co. Ltd78 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Healthy Volunteers

Interventions

ONO-4685BIOLOGICAL

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

PlaceboBIOLOGICAL

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

KLHBIOLOGICAL

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

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Fukuoka Clinical Site

Hakata, Fukuoka, Japan

Outcomes

Primary Outcomes

Adverse events [Safety and Tolerability]

Number of participants with adverse events as assessed by CTCAE v5.0

Time frame: Up to 84 days

Vital sign [Safety and Tolerability]

Summary statistics of blood pressure/pulse rate, respiratory rate, SpO2

Time frame: Up to 84 days

Body temperature [Safety and Tolerability]

Summary statistics of body temperature

Time frame: Up to 84 days

Body weight [Safety and Tolerability]

Summary statistics of body weight

Time frame: Up to 84 days

ECG parameter test [Safety and Tolerability]

Summary statistics of ECG parameter test (Heart Rate, RR, PR, QRS, QT, and QTcF)

Time frame: Up to 84 days

Laboratory test [Safety and Tolerability]

Summary statistics of laboratory test (hematologic test, blood biochemistry test, blood coagulation test, immunoserologic test urinalysis)

Time frame: Up to 84 days

Secondary Outcomes

Cmax [Pharmacokinetic] (PartA, C, and D)

Assessment of the Cmax of ONO-4685

Time frame: Up to 84 days

Tmax [Pharmacokinetic] (PartA, C, and D)

Assessment of the Tmax of ONO-4685

Time frame: Up to 84 days

Data from ClinicalTrials.gov

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