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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Biological: ONO-4685; Biological: Placebo; Biological: KLH; Biological: KLH, ONO-4685; Biological: KLH, placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka
    • Hakata, Fukuoka, Japan
      • Fukuoka Clinical site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ONO-4685 (PartA, D)	Biological: ONO-4685; Single ascending dose of ONO-4685 will be administered by intravenous continuous infusion at the designated speed.
Placebo Comparator: Placebo (PartA, D)	Biological: Placebo; Placebo will be administered by intravenous continuous infusion at the designated speed.
Experimental: KLH+placebo (Part B)	Biological: KLH; KLH 1 mg per dose will be subcutaneously administered. In addition, all subjects will be administered placebo after KLH administration.
Experimental: KLH+ONO-4685 (PartC)	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.
Experimental: KLH+placebo (PartC)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events [Safety and Tolerability]	Number of participants with adverse events as assessed by CTCAE v5.0	Up to 84 days
Vital sign [Safety and Tolerability]	Summary statistics of blood pressure/pulse rate, respiratory rate, SpO2	Up to 84 days
Body temperature [Safety and Tolerability]	Summary statistics of body temperature	Up to 84 days
Body weight [Safety and Tolerability]	Summary statistics of body weight	Up to 84 days
ECG parameter test [Safety and Tolerability]	Summary statistics of ECG parameter test (Heart Rate, RR, PR, QRS, QT, and QTcF)	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)	Up to 84 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax [Pharmacokinetic] (PartA, C, and D)	Assessment of the Cmax of ONO-4685	Up to 84 days
Tmax [Pharmacokinetic] (PartA, C, and D)	Assessment of the Tmax of ONO-4685	Up to 84 days
AUC [Pharmacokinetic] (PartA, C, and D)	Assessment of the AUC168h, AUClast, and AUCinf of ONO-4685	Up to 84 days
T1/2 [Pharmacokinetic] (PartA, C, and D)	Assessment of the T1/2 of ONO-4685	Up to 84 days
CL [Pharmacokinetic] (PartA, C, and D)	Assessment of the CL of ONO-4685	Up to 84 days
Vss [Pharmacokinetic] (PartA, C, and D)	Assessment of the Vss of ONO-4685	Up to 84 days
Serum cytokine concentration [Pharmacodynamics] (PartA, C, and D)	Serum cytokine concentration	Up to 84 days
Hemocyte test [Pharmacodynamics] (PartA, C, and D)	Hemocyte test	Up to 84 days
Pharmacodynamics (Part B and C)	Anti-KLH antibody	Up to 84 days
Immunogenicity (PartA, C, and D)	Anti-ONO-4685 antibody	Up to 84 days

Collaborators and Investigators

• Sponsor: Ono Pharmaceutical Co. Ltd
• Investigators: Study Director: Junichiro Manako, Ono Pharmaceutical Co. Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2019
• Primary Completion (Actual): May 25, 2021
• Study Completion (Actual): May 25, 2021

Study Registration Dates

• First Submitted: August 25, 2019
• First Submitted That Met QC Criteria: September 2, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 9, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: ONO-4685-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: https://www.ono.co.jp/eng/rd/policy.html

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No