Safety Study of Tezepelumab (AMG 157) in Healthy Adults and Adults With Atopic Dermatitis

Amgen

Status and phase

Completed

Phase 1

Conditions

Atopic Dermatitis

Healthy Volunteers

Treatments

Drug: Placebo

Drug: Tezepelumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00757042

20070620

Details and patient eligibility

About

This study is a single dose escalation study of tezepelumab (AMG 157) in healthy adults (Part A) and adults with moderate to severe atopic dermatitis (Part B). The purpose of the study is to evaluate the safety, tolerability, immunogenicity and pharmacokinetics of tezepelumab.

Enrollment

78 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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/m^2, inclusive
Subject must have normal or clinically acceptable physical examination, clinical laboratory tests and electrocardiogram (ECG) results
For Part B, subject must have active atopic dermatitis (AD) affecting ≥ 10% body surface area; Eczema Area and Severity Index (EASI) score ≥ 15, aged between 18 and 60 years, inclusive and BMI between 18 and 35 kg/m^2, 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)
Subject has known type I/II diabetes
Subject used nonprescription drugs within 14 days prior to randomization and during the study
Subject used any cytotoxic or immunosuppressive drugs with 30 days or 5 half-lives prior to randomization and during the study
Subject previously received a monoclonal antibody
Subject donated blood or had loss of blood of equal to or greater than 500 mL with 2 months of screening
Subject positive for human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C antibodies
Subject has any condition that might compromise informed consent or compliance to the protocol
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, ultraviolet [UV] A, 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 nonsteroidal anti-inflammatory drugs [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.