Safety Study of AMG 157 in Healthy Subjects and Subjects With Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00757042
First received: September 18, 2008
Last updated: May 19, 2011
Last verified: May 2011
  Purpose

This study is a phase 1 single dose escalation study of AMG 157 in healthy subjects and subjects with moderate to severe atopic dermatitis. The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of AMG 157.


Condition Intervention Phase
Atopic Dermatitis
Healthy Volunteers
Drug: AMG 157
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 157 in Healthy Subjects and Subjects With Moderate to Severe Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Safety evaluations: Subject incidence of treatment-emergent adverse events, clinically significant changes in vital signs, physical examinations, laboratory safety tests, ECGs, and the development of anti-AMG 157 antibodies [ Time Frame: Part A - 85 days; Part B - 113 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Eczema Area & Severity Index (EASI) score and Investigator's Global Assessment (IGA) score [ Time Frame: Part B only - 113 days ] [ Designated as safety issue: No ]
  • Serum PK parameters [ Time Frame: Part A - 85 days; Part B - 113 days ] [ Designated as safety issue: No ]

Enrollment: 78
Study Start Date: October 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AMG 157
Six subjects in each cohort (cohort 1 to 8) will receive AMG 157 in Part A 18 subjects in cohorts 9 and 10 (Part B) will receive AMG 157
Drug: AMG 157
Part A (healthy subjects): 6 subcutaneous (SC) cohorts and 2 intravenous (IV) cohorts receiving a single dose of either AMG 157 (dose escalating by cohort) or placebo. Part B (subjects with moderate to severe atopic dermatitis):two cohorts receiving a single dose (SC or IV; dose to be determined) of AMG 157 or placebo.
Placebo Comparator: placebo
2 subjects of each cohort (cohort 1 to 8) will receive placebo in Part A 6 subjects in cohorts 9 and 10 (Part B) will receive placebo
Drug: AMG 157
Part A (healthy subjects): 6 subcutaneous (SC) cohorts and 2 intravenous (IV) cohorts receiving a single dose of either AMG 157 (dose escalating by cohort) or placebo. Part B (subjects with moderate to severe atopic dermatitis):two cohorts receiving a single dose (SC or IV; dose to be determined) of AMG 157 or placebo.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject must sign an Institutional Review Board (IRB) approved informed consent form before any study specific procedures
  • Subjects must be aged between 18 and 45 years, inclusive (Part A only)
  • Female subjects must be of non-reproductive potential
  • Male subjects with partners of childbearing potential should inform their partner of their participation in this clinical study and use highly effective methods of birth control during the study
  • Healthy subjects must have a body mass index (BMI) between 18 to 32 kg/m2, inclusive
  • Subject must have normal or clinically acceptable physical examination, clinical laboratory tests and electrocardiogram (ECG) results
  • For Part B, Subject must have active AD affecting ≥10% body surface area; EASI score ≥15, aged between 18 and 60 years, inclusive and BMI between 18 and 35 kg/m2, inclusive

Exclusion Criteria:

  • Subject who has history or evidence of a clinically significant disorder, condition or disease that, in the opinion of the Investigator in consultation with the Amgen physician, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
  • Subject who has evidence of any active or suspected bacterial, viral, fungal or parasitic infections within the past 30 days prior to randomization
  • Subject who has known positive tuberculin skin test or recent (within 6 months from randomization) exposure to an individual with active tuberculosis
  • Subject who has history of malignancy within 5 years before randomization
  • Subject who has history of significant dermatological conditions (except for atopic dermatitis in Part B)
  • Subject who has previously received any investigational drug (or is currently using an investigational device) within 30 days prior to randomization
  • Subject who has tested positive for drugs and/or alcohol use at screening or before randomization
  • Female subjects who are pregnant or lactating
  • Subject who has used nicotine or tobacco containing products during 6 months before randomization and during the study (except for Part B below)
  • For atopic dermatitis subjects in Part B (Cohorts 9 and 10) only, additional exclusion criteria are as follows:

Subject who has concurrent skin disease (eg, acne) of such severity in the study area that it could interfere with study evaluation; Subject who has active or recent skin infections (within 7 days of randomization); Subject who has received phototherapy (eg, UVA, UVB) known or suspected to have an effect on AD within 6 weeks prior to randomization; Subject who has received corticosteroids by other than topical, inhaled or intranasal delivery within 4 weeks prior to randomization; Subject who has been treated with topical calcineurin inhibitors within 14 days prior to randomization; Subject who uses any medications that interfere with blood coagulation (eg NSAIDs) or wound healing within 7 days or 5 half-lives (whichever is longer) prior to enrolling into the study and for the duration of the study.

Subject who smokes more than 10 cigarettes per day within the 6 months prior to randomization and during the study.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757042

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00757042     History of Changes
Other Study ID Numbers: 20070620
Study First Received: September 18, 2008
Last Updated: May 19, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
atopic dermatitis
skin diseases
healthy volunteer

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 18, 2014