CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 84 enrolled
Drug / intervention
700 mg IV +3 moredrug
Likely dose
700 mg IVfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00867100
NCT00867100Phase 1Completed

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

Bausch Health Americas, Inc.·interventional·Posted Mar 23, 2009·Updated Jan 16, 2019

In Brief

A Phase 1 clinical trial evaluating 700 mg IV, 350 mg SC, and 2 other interventions for Psoriasis. Completed, enrolled 84 participants.

Detailed Summary

This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 23, 2009
Enrollment StartDec 1, 2007
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.3 years ago

Interventions

700 mg IVdrug

single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).

350 mg SCdrug

single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).

Placebodrug

single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).

140 mg SCdrug

single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).