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Pharmacokinetic Study of KHK7580 in Healthy Adult Volunteers

NCT04206657 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-09-08

No results posted yet for this study

Summary

The primary objective is to evaluate the pharmacokinetic profile of KHK7580 in Chinese healthy adult volunteers. The secondary objective is to evaluate its safety and pharmacodynamics.

Conditions

  • Healthy Volunteer

Interventions

DRUG

1mg KHK7580

Single oral dose administration of 1mg KHK7580

DRUG

3mg KHK7580

Single oral dose administration of 3mg KHK7580

DRUG

6mg KHK7580

Single oral dose administration of 6mg KHK7580

DRUG

12mg KHK7580

Single oral dose administration of 12mg KHK7580

DRUG

6mg KHK7580 for 8days

multiple oral dose administration of 6mg KHK7580 for 8days

Sponsors & Collaborators

  • Kyowa Kirin China Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Kyowa Kirin Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-20
Primary Completion
2021-06-17
Completion
2021-06-17

Countries

  • China

Study Locations

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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 NCT04206657 on ClinicalTrials.gov