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

NCT04079062 | Completed Phase 1

• 1 other identifier: ONO-4685-01
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (10)

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

  Up to 84 days

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

  Up to 84 days

• AUC [Pharmacokinetic] (PartA, C, and D)

  Up to 84 days

• T1/2 [Pharmacokinetic] (PartA, C, and D)

  Up to 84 days

• CL [Pharmacokinetic] (PartA, C, and D)

  Up to 84 days

Study Arms (5)

ONO-4685 (PartA, D)

EXPERIMENTAL

Biological: ONO-4685

Placebo (PartA, D)

PLACEBO COMPARATOR

Biological: Placebo

KLH+placebo (Part B)

EXPERIMENTAL

Biological: KLH

KLH+ONO-4685 (PartC)

EXPERIMENTAL

Biological: KLH, ONO-4685

KLH+placebo (PartC)

EXPERIMENTAL

Biological: KLH, placebo

Interventions

ONO-4685 BIOLOGICAL

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

ONO-4685 (PartA, D)

Placebo BIOLOGICAL

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

Placebo (PartA, D)

KLH BIOLOGICAL

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

KLH+placebo (Part B)

KLH, ONO-4685 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+ONO-4685 (PartC)

KLH, placebo 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.

KLH+placebo (PartC)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ono Pharmaceutical Co. Ltd: lead

Study Sites (1)

Fukuoka Clinical Site

Hakata, Fukuoka, Japan

Location

MeSH Terms

Interventions

keyhole-limpet hemocyanin

Study Officials

• Junichiro Manako

  Ono Pharmaceutical Co. Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2019
• First Posted: September 6, 2019
• Study Start: September 12, 2019
• Primary Completion: May 25, 2021
• Study Completion: May 25, 2021
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)