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

Ono Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Biological: ONO-4685; Biological: KLH, ONO-4685; Biological: KLH, placebo; Biological: Placebo; Biological: KLH

Study type: Interventional

Funder types: Industry

Identifiers

NCT04079062

ONO-4685-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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78 participants in 5 patient groups, including a placebo group

ONO-4685 (PartA, D)

Experimental group

Treatment:

Biological: ONO-4685

Placebo (PartA, D)

Placebo Comparator group

Treatment:

Biological: Placebo

KLH+placebo (Part B)

Experimental group

Treatment:

Biological: KLH

KLH+ONO-4685 (PartC)

Experimental group

Treatment:

Biological: KLH, ONO-4685

KLH+placebo (PartC)

Experimental group

Treatment:

Biological: KLH, placebo