This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
84
single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
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.
Time frame: Through day 43
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.
Time frame: 85 days
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.
Time frame: Cohort 1-4 43 days, Cohort 5-8 64 days
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single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).