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

Location

Nucleus Network Limited

Melbourne, Victoria, Australia, 3004

Location

Clinical Medical and Analytical eXcellence (CMAX)

Adelaide, Australia, SA500

Location

QPharm Pty Limited

Herston, Australia, 4006

Location

Auckland Clinical Studies Ltd

Grafton, New Zealand, 1010

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).

"There is no result for the study"

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Nucleus Network Limited

Clinical Medical and Analytical eXcellence (CMAX)

QPharm Pty Limited

Auckland Clinical Studies Ltd

Trial Results Summaries