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

NCT03846466 | Terminated Phase 1

• 1 other identifier: 4323-001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  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.

  Part 1: from Day 1 through at most Day 169, Part 2: from Day 1 through at most Day 225

Secondary Outcomes (2)

• 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

• 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

Other Outcomes (6)

• Change from baseline in Eczema Area and Severity Index (EASI)

  Part2: Day1(Pre-dose), Day 15, Day 29,Day 43, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225

• Percent change in Eczema Area and Severity Index (EASI)

  Part2: Day1(Pre-dose), Day 15, Day 29,Day 43, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225

• Change from baseline in Body surface area (BSA) of involvement of Atopic dermatitis

  Part2 Day1(Pre-dose), Day 15, Day 29, Day 43, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225

Study Arms (18)

Part1 Dose 1A

EXPERIMENTAL

Single administration

Drug: KHK4323 IV/S

Part1 Dose 1P

PLACEBO COMPARATOR

Single administration

Drug: Placebo IV/S

Part1 Dose 2A

EXPERIMENTAL

Single administration

Drug: KHK4323 IV/S

Part1 Dose 2P

PLACEBO COMPARATOR

Single administration

Drug: Placebo IV/S

Part1 Dose 3A

EXPERIMENTAL

Single administration

Drug: KHK4323 IV/S

Part1 Dose 3P

PLACEBO COMPARATOR

Single administration

Drug: Placebo IV/S

Part1 Dose 4A

EXPERIMENTAL

Single administration

Drug: KHK4323 IV/S

Part1 Dose 4P

PLACEBO COMPARATOR

Single administration

Drug: Placebo IV/S

Part1 Dose 5A

EXPERIMENTAL

Single administration

Drug: KHK4323 SC/S

Part1 Dose 5P

PLACEBO COMPARATOR

Single administration

Drug: Placebo SC/S

Part1 Dose 6A

EXPERIMENTAL

Single administration

Drug: KHK4323 IV/S

Part1 Dose 6P

PLACEBO COMPARATOR

Single administration

Drug: Placebo IV/S

Part1 Dose 7A

EXPERIMENTAL

Single administration

Drug: KHK4323 IV/S

Part1 Dose 7P

PLACEBO COMPARATOR

Single administration

Drug: Placebo IV/S

Part2 Dose 1A

EXPERIMENTAL

Multiple administration

Drug: KHK4323 IV/M

Part2 Dose 1P

PLACEBO COMPARATOR

Multiple administration

Drug: Placebo IV/M

Part2 Dose 2A

EXPERIMENTAL

Multiple administration

Drug: KHK4323 IV/M

Part2 Dose 2P

PLACEBO COMPARATOR

Multiple administration

Drug: Placebo IV/M

Interventions

KHK4323 IV/S DRUG

IV / Single administration

Part1 Dose 1A; Part1 Dose 2A; Part1 Dose 3A; Part1 Dose 4A; Part1 Dose 6A; Part1 Dose 7A

KHK4323 SC/S DRUG

SC / Single administration

Part1 Dose 5A

KHK4323 IV/M DRUG

IV / Multiple administration

Part2 Dose 1A; Part2 Dose 2A

Placebo IV/S DRUG

IV / Single administration

Part1 Dose 1P; Part1 Dose 2P; Part1 Dose 3P; Part1 Dose 4P; Part1 Dose 6P; Part1 Dose 7P

Placebo IV/M DRUG

IV / Multiple administration

Part2 Dose 1P; Part2 Dose 2P

Placebo SC/S DRUG

SC / Single administration

Part1 Dose 5P

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (1)

Osaka Pharmacology Clinical research Hospital

Osaka, Japan

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2019
• First Posted: February 19, 2019
• Study Start: February 22, 2019
• Primary Completion: December 11, 2019
• Study Completion: December 11, 2019
• Last Updated: January 28, 2020

Record last verified: 2020-01

Locations

JP (1)