Study Complete
Sponsor ID
20080767

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects with Moderate to Severe Psoriasis

Sponsor ID
20080767
Clinicaltrials.gov ID
NCT01094093
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The purpose of this study is to assess the safety and tolerability of AMG 139 following single subcutaneous (SC) or intravenous (IV) dose administration in healthy subjects and subjects with moderate to severe psoriasis (PsO).

Additional Study Details

Phase
Phase 1
Product
AMG 139
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
73
Additional Study Details

Protocol Summary

Primary Outcome Measures

Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 139

Timeframe: 16-24 weeks

Secondary Outcome Measures

Characterization of the pharmacokinetics (PK) of AMG 139

Timeframe: 16-24 weeks

Psoriasis Activity and Severity Index (PASI) scores (Part B only)

Timeframe: 16-24 weeks

Study Documents

Study Synopsis
Available Language(s): English

Locations

No locations found.