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

Psoriasis Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827 in Healthy Subjects and Subjects With Moderate to Severe Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00867100
• Other study ID #: 20060279
• Status: Completed
• Phase: Phase 1
• Start date: December 2007
• Est. completion date: September 2009

Study information

• Verified date: July 2018
• Source: Valeant Pharmaceuticals International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• 700 mg IV
single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
• 350 mg SC
single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
• Placebo
single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
• 140 mg SC
single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Valeant Pharmaceuticals International, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part B: PASI (Psoriasis Area and Severity Index) Score Mean Percentage of Change Through Day 43	Summary of percent change in PASI (Psoriasis Area Severity Index) Scores over time by treatment groups between baseline and day 43, PASI score ranging from (0) no disease to (72) maximal disease.	Through day 43
Primary	Part B: All Treatment Adverse Events Reported for Safety Evaluation	This primary outcome assesses number of participants iwth any reported adverse events emerging during treatment period.	85 days
Primary	Part A: All Treatment Adverse Events Reported for Safety Evaluation	This primary outcome assesses the number of participants with any reported adverse events emerging during treatment period.	Cohort 1-4 43 days, Cohort 5-8 64 days

External Links

•   AmgenTrials clinical trials website