Study Complete
Sponsor ID
20060279

Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827 in Healthy Subjects and Subjects with Moderate to Severe Psoriasis

Sponsor ID
20060279
Clinicaltrials.gov ID
NCT00867100
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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).

Additional Study Details

Phase
Phase 1
Product
AMG 827
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
84
Additional Study Details

Protocol Summary

Primary Outcome Measures

Safety & tolerability: AE’s, clinically significant changes in safety labs, PE, vital signs, and development of anti-AMG 827 antibodies

Timeframe: 9-12 Weeks

Secondary Outcome Measures

Characterize the pharmacokinetics (PK) of AMG 827 following single dose SC or IV administration in healthy subjects and subjects with moderate to severe PsO.

Timeframe: 9-12 Weeks

Study Documents

Study Synopsis
Available Language(s): English

Locations

No locations found.