NCT05439148

OPC-61815 in Healthy Chinese Male Subjects

A Phase I, Open-label, Single- and Multi-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacological Effect of OPC-61815 in Healthy Chinese Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Otsuka Beijing Research Institute · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To evaluate the pharmacokinetic (PK) characteristics and pharmacological effect of OPC-61815 in healthy Chinese Male subjects

Detailed description

To evaluate the pharmacokinetic (PK) characteristics of single and multiple intravenous administration of OPC-61815 in healthy Chinese subjects. To evaluate the safety of single and multiple intravenous administration of OPC-61815 in healthy Chinese subjects. To evaluate the pharmacological effect of single and multiple intravenous administration of OPC-61815 in healthy Chinese subjects.

Conditions

• Healthy Adult Male

Interventions

Type	Name	Description
DRUG	OPC-61815 injection	Intravenous administration of OPC-61815 at 8 mg or 16 mg. 8mg group will be intravenously administered only on D1, once a day. 16mg group will be intravenously administered on D1，D3-D9, once a day.

Timeline

• Start date: 2022-06-30
• Primary completion: 2022-09-21
• Completion: 2022-09-21
• First posted: 2022-06-30
• Last updated: 2023-10-13

Locations

1 site across 1 country: China