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
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Psoriasis
- Sponsor
- Bausch Health Americas, Inc.
- Enrollment
- 84
- Primary Endpoint
- Part B: PASI (Psoriasis Area and Severity Index) Score Mean Percentage of Change Through Day 43
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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 (Part B).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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
- •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
- •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
Arms & Interventions
Placebo
Placebo treatment
Intervention: Placebo
140 mg SC
140 mg SC PsO
Intervention: 140 mg SC
350 mg SC
350 mg SC PsO
Intervention: 350 mg SC
700 mg IV
700 mg IV PsO
Intervention: 700 mg IV
Outcomes
Primary Outcomes
Part B: PASI (Psoriasis Area and Severity Index) Score Mean Percentage of Change Through Day 43
Time Frame: 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.
Part B: All Treatment Adverse Events Reported for Safety Evaluation
Time Frame: 85 days
This primary outcome assesses number of participants iwth any reported adverse events emerging during treatment period.
Part A: All Treatment Adverse Events Reported for Safety Evaluation
Time Frame: Cohort 1-4 43 days, Cohort 5-8 64 days
This primary outcome assesses the number of participants with any reported adverse events emerging during treatment period.