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

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

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).

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: AMG 139

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia, SA500
    • Clinical Medical and Analytical Excellence (CMAX)
  • Herston, Australia, 4006
    • QPharm Pty Limited
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Nucleus Network Limited
• New Zealand
  • Grafton, New Zealand, 1010
    • Auckland Clinical Studies Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Characterization of the pharmacokinetics (PK) of AMG 139	16-24 weeks
Psoriasis Activity and Severity Index (PASI) scores (Part B only)	16-24 weeks

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2010
• Primary Completion (Actual): July 26, 2011
• Study Completion (Actual): July 26, 2011

Study Registration Dates

• First Submitted: March 25, 2010
• First Submitted That Met QC Criteria: March 25, 2010
• First Posted (Estimate): March 26, 2010

Study Record Updates

• Last Update Posted (Actual): May 10, 2021
• Last Update Submitted That Met QC Criteria: May 6, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Amgen; AMG 139
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 20080767