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

NCT01094093 | Completed Phase 1

• 1 other identifier: 20080767
• Study Type: interventional
• Target: 73
• Locations: 2 countries
• Sites: 4

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).

Conditions

Psoriasis

Keywords

Amgen; AMG 139

Outcome Measures

Primary Outcomes (1)

• Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 139

  16-24 weeks

Secondary Outcomes (2)

• Characterization of the pharmacokinetics (PK) of AMG 139

  16-24 weeks

• Psoriasis Activity and Severity Index (PASI) scores (Part B only)

  16-24 weeks

Study Arms (2)

Part B

EXPERIMENTAL

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

Part A

EXPERIMENTAL

Six dose levels of AMG 139 administered as a single dose SC or IV in healthy volunteers.

Drug: AMG 139

Interventions

AMG 139 DRUG

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).

Part A; Part B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (4)

Nucleus Network Limited

Melbourne, Victoria, 3004, Australia

Location

Clinical Medical and Analytical eXcellence (CMAX)

Adelaide, SA500, Australia

Location

QPharm Pty Limited

Herston, 4006, Australia

Location

Auckland Clinical Studies Ltd

Grafton, 1010, New Zealand

Location

MeSH Terms

Conditions

Psoriasis

Interventions

AMG 139

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2010
• First Posted: March 26, 2010
• Study Start: April 11, 2010
• Primary Completion: July 26, 2011
• Study Completion: July 26, 2011
• Last Updated: May 10, 2021

Record last verified: 2021-05

Locations

NZ (1); AU (3)