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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01094093

Enrollment

Registered

2010-03-26

Start date

2010-04-11

Completion date

2011-07-26

Last updated

2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

Amgen, AMG 139

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).

Interventions

DRUGAMG 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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

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

Countries

Australia, New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026