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A Study of Single and Multiple Doses of KW-6356 in Healthy Subjects

NCT03830528 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2019-11-29

No results posted yet for this study

Summary

Phase I study to assess the safety, tolerability and pharmacokinetics of single and multiple doses of KW-6356 in healthy volunteers

Conditions

Interventions

DRUG

KW-6356 Low Dose

KW-6356 will be administered as single doses.

DRUG

KW-6356 Middle Dose

KW-6356 will be administered as single doses.

DRUG

KW-6356 High Dose

KW-6356 will be administered as single doses.

DRUG

KW-6356 X Dose

KW-6356 will be administered as multiple doses.

DRUG

KW-6356 Y Dose

KW-6356 will be administered for Japanese healthy men as multiple doses.

DRUG

Placebo

All study cohorts (except Part C) are placebo controlled.

Sponsors & Collaborators

  • Kyowa Kirin Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
44 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-26
Primary Completion
2019-10-10
Completion
2019-10-10

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03830528 on ClinicalTrials.gov