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

NCT ID: NCT03846466

Last Updated: 2020-01-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-22
• Study Completion Date: 2019-12-11

Brief 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

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Part1 Dose 1A

Single administration

Group Type: EXPERIMENTAL

KHK4323 IV/S

Intervention Type: DRUG

IV / Single administration

Part1 Dose 1P

Single administration

Group Type: PLACEBO_COMPARATOR

Placebo IV/S

Intervention Type: DRUG

IV / Single administration

Part1 Dose 2A

Single administration

Group Type: EXPERIMENTAL

KHK4323 IV/S

Intervention Type: DRUG

IV / Single administration

Part1 Dose 2P

Single administration

Group Type: PLACEBO_COMPARATOR

Placebo IV/S

Intervention Type: DRUG

IV / Single administration

Part1 Dose 3A

Single administration

Group Type: EXPERIMENTAL

KHK4323 IV/S

Intervention Type: DRUG

IV / Single administration

Part1 Dose 3P

Single administration

Group Type: PLACEBO_COMPARATOR

Placebo IV/S

Intervention Type: DRUG

IV / Single administration

Part1 Dose 4A

Single administration

Group Type: EXPERIMENTAL

KHK4323 IV/S

Intervention Type: DRUG

IV / Single administration

Part1 Dose 4P

Single administration

Group Type: PLACEBO_COMPARATOR

Placebo IV/S

Intervention Type: DRUG

IV / Single administration

Part1 Dose 5A

Single administration

Group Type: EXPERIMENTAL

KHK4323 SC/S

Intervention Type: DRUG

SC / Single administration

Part1 Dose 5P

Single administration

Group Type: PLACEBO_COMPARATOR

Placebo SC/S

Intervention Type: DRUG

SC / Single administration

Part1 Dose 6A

Single administration

Group Type: EXPERIMENTAL

KHK4323 IV/S

Intervention Type: DRUG

IV / Single administration

Part1 Dose 6P

Single administration

Group Type: PLACEBO_COMPARATOR

Placebo IV/S

Intervention Type: DRUG

IV / Single administration

Part1 Dose 7A

Single administration

Group Type: EXPERIMENTAL

KHK4323 IV/S

Intervention Type: DRUG

IV / Single administration

Part1 Dose 7P

Single administration

Group Type: PLACEBO_COMPARATOR

Placebo IV/S

Intervention Type: DRUG

IV / Single administration

Part2 Dose 1A

Multiple administration

Group Type: EXPERIMENTAL

KHK4323 IV/M

Intervention Type: DRUG

IV / Multiple administration

Part2 Dose 1P

Multiple administration

Group Type: PLACEBO_COMPARATOR

Placebo IV/M

Intervention Type: DRUG

IV / Multiple administration

Part2 Dose 2A

Multiple administration

Group Type: EXPERIMENTAL

KHK4323 IV/M

Intervention Type: DRUG

IV / Multiple administration

Part2 Dose 2P

Multiple administration

Group Type: PLACEBO_COMPARATOR

Placebo IV/M

Intervention Type: DRUG

IV / Multiple administration

Interventions

KHK4323 IV/S

IV / Single administration

Intervention Type: DRUG

KHK4323 SC/S

SC / Single administration

Intervention Type: DRUG

KHK4323 IV/M

IV / Multiple administration

Intervention Type: DRUG

Placebo IV/S

IV / Single administration

Intervention Type: DRUG

Placebo IV/M

IV / Multiple administration

Intervention Type: DRUG

Placebo SC/S

SC / Single administration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Part 1:

• Japanese or Caucasian male aged 20 to under 45 years old at the time consent was obtained
• BMI ≥ 18.5 to < 30.0 at time of screening tests

Part 2:

• Men and women aged 18 years or older at the time of consent
• Patients with EASI ≥ 16 in pre-administration testing
• Patients with IGA of "3: Moderate" or higher in pre-administration testing
• Patients with BSA ≥ 10% at screening in pre-administration testing

Exclusion Criteria

Part 1:

• Persons with existing respiratory disease, heart disease, gastrointestinal disease, kidney disease, or liver disease
• Persons confirmed to have a bacterial, viral, fungal, or parasitic infection within 28 days prior to obtainment of consent
• Persons who have contracted an infectious disease requiring hospitalization or IV administration of an antibiotic within 6 months prior to obtainment of consent
• Persons who have been treated with a biological preparation (antibody, etc.) or have been administered an investigational drug within 6 months prior to the obtainment of consent
• Persons who have used a medication (including over-the-counter drugs, topical agents, vitamins, and herbal medicines) within 2 weeks prior to obtainment of consent (for an immunosuppressant drug, within 60 days)
• Persons who routinely smoke an average of more than 10 cigarettes a day (to be confirmed in interview at time of screening tests) or cannot follow the rules regarding smoking during the clinical trial period

Part 2:

• Patients with severe complications judged to affect the implementation and evaluation of the study in the opinion of the investigator or sub-investigator. Includes but is not limited to the following. Severe cardiovascular disease (e.g., class III or IV according to New York Heart Association functional classification), poorly controlled diabetes mellitus (HbA1c > 8.5%), poorly controlled hypertension, liver disease with severity of moderate or higher (e.g., class B or C according to Child-Pugh classification), kidney disease, respiratory disease, gastrointestinal disease, blood dyscrasia, central nervous system disease, psychiatric disease, autoimmune disease, etc.
• Patients observed to have one of the following laboratory test abnormalities in screening tests

• Neutrophil count: < 1500/μL
• Serum creatinine: > 1.5 mg/dL
• AST or ALT: > 2.5-fold the upper limit of the reference range
• Other laboratory test abnormalities that the investigator or sub-investigator thinks could affect the completion or evaluation of the clinical trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Osaka Pharmacology Clinical research Hospital

Osaka, , Japan

Countries

Japan

Other Identifiers

4323-001

Identifier Type: -

Identifier Source: org_study_id