Clinical trial NCT04079062: Single Ascending Dose Study to Assess the Safety, Tolerability, PK and PD of ONO-4685 in Japanese and Caucasian Healthy Adult Male Subjects
Official title: Single Ascending Dose Study to Assess the Safety, Tolerability, PK and PD of ONO-4685 in Japanese and Caucasian Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2019-09-06
Enrollment: 78
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adverse events [Safety and Tolerability]
timeFrame: Up to 84 days
measure: Vital sign [Safety and Tolerability]
timeFrame: Up to 84 days
measure: Body temperature [Safety and Tolerability]
timeFrame: Up to 84 days
measure: Body weight [Safety and Tolerability]
timeFrame: Up to 84 days
measure: ECG parameter test [Safety and Tolerability]
timeFrame: Up to 84 days
measure: Laboratory test [Safety and Tolerability]
timeFrame: Up to 84 days
Secondary outcomes:
measure: Cmax [Pharmacokinetic] (PartA, C, and D)
timeFrame: Up to 84 days
measure: Tmax [Pharmacokinetic] (PartA, C, and D)
timeFrame: Up to 84 days
measure: AUC [Pharmacokinetic] (PartA, C, and D)
timeFrame: Up to 84 days
measure: T1/2 [Pharmacokinetic] (PartA, C, and D)
timeFrame: Up to 84 days
measure: CL [Pharmacokinetic] (PartA, C, and D)
timeFrame: Up to 84 days
measure: Vss [Pharmacokinetic] (PartA, C, and D)
timeFrame: Up to 84 days
measure: Serum cytokine concentration [Pharmacodynamics] (PartA, C, and D)
timeFrame: Up to 84 days
measure: Hemocyte test [Pharmacodynamics] (PartA, C, and D)
timeFrame: Up to 84 days
measure: Pharmacodynamics (Part B and C)
timeFrame: Up to 84 days
measure: Immunogenicity (PartA, C, and D)
timeFrame: Up to 84 days
Other outcomes:
Locations:
city: Hakata
country: Japan
facility: Fukuoka Clinical Site
state: Fukuoka
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Junichiro Manako
role: STUDY_DIRECTOR
References: