Status:
COMPLETED
Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Psoriasis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose.
Detailed 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 (Par...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00867100
Start Date
December 1 2007
End Date
September 1 2009
Last Update
January 16 2019
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