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OPC-61815 in Healthy Chinese Male Subjects

NCT05439148 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-10-13

No results posted yet for this study

Summary

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

Conditions

  • Healthy Adult Male

Interventions

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.

Sponsors & Collaborators

  • Otsuka Beijing Research Institute

    lead INDUSTRY

Principal Investigators

  • Hongyun Wang · Peking Union Medical College Hospital

  • Hongzhong Liu · Peking Union Medical College Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2022-09-21
Completion
2022-09-21

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05439148 on ClinicalTrials.gov