Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827

Bausch Health

Status and phase: Completed; Phase 1

Conditions: Psoriasis

Treatments: Drug: Placebo; Drug: 350 mg SC; Drug: 140 mg SC; Drug: 700 mg IV

Study type: Interventional

Funder types: Industry

Identifiers

NCT00867100

20060279

Details and patient eligibility

About

This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose.

Full description

This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).

Enrollment: 84 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Part A:

• Able to provide written informed consent
• Healthy male or female between 18 to 45 years of age, inclusive at the time of screening
• Additional inclusion criteria apply

Part B:

• 18 - 55 years old inclusive at Screening
• Active but clinically stable, plaque psoriasis
• Psoriasis involving ≥ 10% of the body surface area
• A minimum PASI score of ≥ 10 obtained during the screening period
• Additional inclusion criteria apply

Exclusion criteria

Part A:

• History or evidence of a clinically significant disorder (including but not limited to cardiopulmonary, oncologic, renal, metabolic, hematologic or psychiatric), condition or disease that, in the opinion of the Investigator and Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
• Underlying condition that predisposes the subject to infections (eg, uncontrolled diabetes - HbA1c > 7%, history of splenectomy)
• Additional exclusion criteria apply

Part B:

• Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit
• Evidence of skin conditions other than psoriasis (eg, eczema) at the time of the screening visit or between the screening visit and study drug initiation that would interfere with evaluations of the effect of investigational product on psoriasis
• Any condition that, in the judgment of the investigator, might cause this study to be detrimental to the subject
• Additional exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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84 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo treatment

Treatment:

Drug: Placebo

140 mg SC

Experimental group

Description:

140 mg SC PsO

Treatment:

Drug: 140 mg SC

350 mg SC

Active Comparator group

Description:

350 mg SC PsO

Treatment:

Drug: 350 mg SC

700 mg IV

Experimental group

Description:

700 mg IV PsO

Treatment:

Drug: 700 mg IV