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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04079062
• Other study ID #: ONO-4685-01
• Status: Completed
• Phase: Phase 1
• Start date: September 12, 2019
• Est. completion date: May 25, 2021

Study information

• Verified date: May 2024
• Source: Ono Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: May 25, 2021
• Est. primary completion date: May 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Biological:
• ONO-4685
Single ascending dose of ONO-4685 will be administered by intravenous continuous infusion at the designated speed.
• Placebo
Placebo will be administered by intravenous continuous infusion at the designated speed.
• KLH
KLH 1 mg per dose will be subcutaneously administered. In addition, all subjects will be administered placebo after KLH administration.
• 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.
• 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.

Locations

Country	Name	City	State
Japan	Fukuoka Clinical Site	Hakata	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events [Safety and Tolerability]	Number of participants with adverse events as assessed by CTCAE v5.0	Up to 84 days
Primary	Vital sign [Safety and Tolerability]	Summary statistics of blood pressure/pulse rate, respiratory rate, SpO2	Up to 84 days
Primary	Body temperature [Safety and Tolerability]	Summary statistics of body temperature	Up to 84 days
Primary	Body weight [Safety and Tolerability]	Summary statistics of body weight	Up to 84 days
Primary	ECG parameter test [Safety and Tolerability]	Summary statistics of ECG parameter test (Heart Rate, RR, PR, QRS, QT, and QTcF)	Up to 84 days
Primary	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	Cmax [Pharmacokinetic] (PartA, C, and D)	Assessment of the Cmax of ONO-4685	Up to 84 days
Secondary	Tmax [Pharmacokinetic] (PartA, C, and D)	Assessment of the Tmax of ONO-4685	Up to 84 days
Secondary	AUC [Pharmacokinetic] (PartA, C, and D)	Assessment of the AUC168h, AUClast, and AUCinf of ONO-4685	Up to 84 days
Secondary	T1/2 [Pharmacokinetic] (PartA, C, and D)	Assessment of the T1/2 of ONO-4685	Up to 84 days
Secondary	CL [Pharmacokinetic] (PartA, C, and D)	Assessment of the CL of ONO-4685	Up to 84 days
Secondary	Vss [Pharmacokinetic] (PartA, C, and D)	Assessment of the Vss of ONO-4685	Up to 84 days
Secondary	Serum cytokine concentration [Pharmacodynamics] (PartA, C, and D)	Serum cytokine concentration	Up to 84 days
Secondary	Hemocyte test [Pharmacodynamics] (PartA, C, and D)	Hemocyte test	Up to 84 days
Secondary	Pharmacodynamics (Part B and C)	Anti-KLH antibody	Up to 84 days
Secondary	Immunogenicity (PartA, C, and D)	Anti-ONO-4685 antibody	Up to 84 days