NCT00867100

Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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).

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	700 mg IV	single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
DRUG	350 mg SC	single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
DRUG	Placebo	single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
DRUG	140 mg SC	single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2009-03-23
• Last updated: 2019-01-16
• Results posted: 2019-01-16