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Study of KHK 4323 in Healthy Volunteers and Subjects With Atopic Dermatitis

NCT03846466 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2020-01-28

No results posted yet for this study

Summary

Part 1: To investigate the safety and tolerability of intravenous (IV) or subcutaneous (SC) administration of a single dose of KHK4323 to Japanese or Caucasian healthy adult males in a double-blind, placebo-controlled study.

Part 2: To investigate the safety and tolerability of intravenous (IV) administration of repeated doses of KHK4323 to atopic dermatitis patients in a double-blind, placebo-controlled study.

Conditions

Interventions

DRUG

KHK4323 IV/S

IV / Single administration

DRUG

KHK4323 SC/S

SC / Single administration

DRUG

KHK4323 IV/M

IV / Multiple administration

DRUG

Placebo IV/S

IV / Single administration

DRUG

Placebo IV/M

IV / Multiple administration

DRUG

Placebo SC/S

SC / Single administration

Sponsors & Collaborators

  • Kyowa Kirin Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-22
Primary Completion
2019-12-11
Completion
2019-12-11

Countries

  • Japan

Study Locations

More Related Trials

Entities

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 NCT03846466 on ClinicalTrials.gov