Clinical trial NCT03846466: Study of KHK 4323 in Healthy Volunteers and Subjects With Atopic Dermatitis
Official title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single Dose or Multiple Dose Study of KHK4323 in Healthy Volunteers, and Subjects With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Atopic Dermatitis
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-02-19
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: Part 1: from Day 1 through at most Day 169, Part 2: from Day 1 through at most Day 225
Secondary outcomes:
measure: Profile of pharmacokinetics of serum KHK4323 concentration in Part 1
timeFrame: 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
measure: Profile of pharmacokinetics of serum KHK4323 concentration in Part 2
timeFrame: 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
Other outcomes:
measure: Change from baseline in Eczema Area and Severity Index (EASI)
timeFrame: Part2: Day1(Pre-dose), Day 15, Day 29,Day 43, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225
measure: Percent change in Eczema Area and Severity Index (EASI)
timeFrame: Part2: Day1(Pre-dose), Day 15, Day 29,Day 43, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225
measure: Change from baseline in Body surface area (BSA) of involvement of Atopic dermatitis
timeFrame: Part2 Day1(Pre-dose), Day 15, Day 29, Day 43, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225
measure: Percent change in Body surface area (BSA) of involvement of Atopic dermatitis
timeFrame: Part2 Day1(Pre-dose), Day 15, Day 29, Day 43, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225
measure: The number of subjects with IGA of 0 or 1 and improvement of 2 points or more over baseline score (IGA responders)
timeFrame: Part2 Day1(Pre-dose), Day 15, Day 29, Day 43, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225
measure: The percentage of subjects with IGA of 0 or 1 and improvement of 2 points or more over baseline score (IGA responders)
timeFrame: Part2 Day1(Pre-dose), Day 15, Day 29, Day 43, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225
Locations:
city: Osaka
country: Japan
facility: Osaka Pharmacology Clinical research Hospital
Study officials:
References: