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

Study identifier:20080767

ClinicalTrials.gov identifier:NCT01094093

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Psoriasis

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AMG 139

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 years - 55 years

Date

Study Start Date: 11 Apr 2010

Primary Completion Date: 26 Jul 2011

Study Completion Date: 26 Jul 2011

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 May 2021 by AstraZeneca

Collaborators

Inclusion and exclusion 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

No locations available

Arms	Assigned Interventions
Experimental: Part B Four dose levels of AMG 139 administered as a single dose SC or IV in subjects with moderate-severe psoriasis (Part B).	Drug: AMG 139 Six dose levels of AMG 139 administered as a single dose SC or IV in healthy volunteers (Part A) and subjects with moderate-severe psoriasis (Part B).
Experimental: Part A Six dose levels of AMG 139 administered as a single dose SC or IV in healthy volunteers.	Drug: AMG 139 Six dose levels of AMG 139 administered as a single dose SC or IV in healthy volunteers (Part A) and subjects with moderate-severe psoriasis (Part B).

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]