Clinical trial NCT01094093: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Moderate to Severe Psoriasis
Official title: A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Moderate to Severe Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Keywords: Amgen
AMG 139
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-03-26
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 139
timeFrame: 16-24 weeks
Secondary outcomes:
measure: Characterization of the pharmacokinetics (PK) of AMG 139
timeFrame: 16-24 weeks
measure: Psoriasis Activity and Severity Index (PASI) scores (Part B only)
timeFrame: 16-24 weeks
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network Limited
state: Victoria
city: Adelaide
country: Australia
facility: Clinical Medical and Analytical eXcellence (CMAX)
city: Herston
country: Australia
facility: QPharm Pty Limited
city: Grafton
country: New Zealand
facility: Auckland Clinical Studies Ltd
Study officials:
References: