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

Phase 1

Terminated

• Conditions: Atopic Dermatitis
• Interventions: Drug: Placebo IV/S; Drug: Placebo IV/M; Drug: KHK4323 IV/S; Drug: Placebo SC/S; Drug: KHK4323 IV/M; Drug: KHK4323 SC/S

• Registration Number: NCT03846466
• Lead Sponsor: Kyowa Kirin Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-17
• Study First Submitted QC: 2019-02-17
• Study First Posted: 2019-02-19
• Study Start: 2019-02-22
• Primary Completion: 2019-12-11
• Study Completion: 2019-12-11
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-26
• Last Update Posted: 2020-01-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

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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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part1 Dose 6P	Placebo IV/S	Single administration
Part2 Dose 2P	Placebo IV/M	Multiple administration
Part1 Dose 1P	Placebo IV/S	Single administration
Part1 Dose 2A	KHK4323 IV/S	Single administration
Part1 Dose 4P	Placebo IV/S	Single administration
Part1 Dose 2P	Placebo IV/S	Single administration
Part1 Dose 5P	Placebo SC/S	Single administration
Part1 Dose 7A	KHK4323 IV/S	Single administration
Part2 Dose 1A	KHK4323 IV/M	Multiple administration
Part1 Dose 3A	KHK4323 IV/S	Single administration
Part2 Dose 2A	KHK4323 IV/M	Multiple administration
Part1 Dose 4A	KHK4323 IV/S	Single administration
Part1 Dose 5A	KHK4323 SC/S	Single administration
Part1 Dose 1A	KHK4323 IV/S	Single administration
Part1 Dose 3P	Placebo IV/S	Single administration
Part1 Dose 6A	KHK4323 IV/S	Single administration
Part1 Dose 7P	Placebo IV/S	Single administration
Part2 Dose 1P	Placebo IV/M	Multiple administration

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	Part 1: from Day 1 through at most Day 169, Part 2: from Day 1 through at most Day 225	For adverse events that occurred after administration of the investigational drug, number of subjects with AEs and occurrence frequency are classified by MedDRA PT and SOC and shown according to dose group.

Secondary Outcome Measures

Name	Time	Method
Profile of pharmacokinetics of serum KHK4323 concentration in Part 1	Day 1 (pre-dose, 1, 6 hours after the start of administration) Day 2, Day 3, Day 4, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141, Day 169	Anti-KHK4323 antibodies
Profile of pharmacokinetics of serum KHK4323 concentration in Part 2	Day 1( pre-dose, 1 hours after the start of administration), Day 8, Day 15, Day 29,Day 43, Day 57, Day 85, Day 113, Day 169, Day 225	Anti-KHK4323 antibodies

Trial Locations

Locations (1)

Osaka Pharmacology Clinical research Hospital; 🇯🇵 Osaka, Japan