Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Moderate to Severe Psoriasis

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Psoriasis

Treatments

Drug: AMG 139

Study type

Interventional

Funder types

Industry

Identifiers

NCT01094093

20080767

Details and patient eligibility

About

The purpose of this study is to assess the safety and tolerability of AMG 139 following single subcutaneous (SC) or intravenous (IV) dose administration in healthy subjects and subjects with moderate to severe psoriasis (PsO).

Enrollment

73 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Part A - Healthy Volunteers:

Healthy male or female of non-reproductive potential subjects between 18 to 45 years-of-age
Body mass index (BMI) between 18 and 32 kg/m2
Normal or clinically acceptable physical examination, clinical laboratory values, and ECG
Additional inclusion criteria apply

Part B - Psoriasis Subjects:

Male or female of non-reproductive potential subjects with PsO between 18 to 55 years-of-age
Body mass index (BMI) between 18 and 32 kg/m2
Normal or clinically acceptable physical examination (PE), clinical laboratory values, and ECG; clinically acceptable PE includes evidence of moderate to severe plaque PsO
Diagnosis of plaque PsO for at least 6 months
Moderate to severe plaque PsO defined by:
A minimum PASI score of ≥ 10
Psoriasis involving ≥ 10% of the Body Surface Area (BSA)
Additional inclusion criteria apply

Exclusion criteria

Parts A - Healthy Volunteers:

History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;
Recent or on-going infection(s)
Underlying condition(s) that predisposes the subject to infections
History of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers in past 5 years
Additional exclusion criteria apply

Part B - Psoriasis Subjects:

History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;
Recent or on-going infection(s)
Underlying condition(s) that predisposes the subject to infections
Guttate, pustular, or other non-plaque forms of PsO
Evidence of skin conditions other than PsO (eg, eczema) that would interfere with evaluations of the effect of investigational product on psoriasis
History of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers in past 5 years
Additional exclusion criteria apply