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

NCT00867100 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2019-01-16

Study results available
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Summary

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

Conditions

Interventions

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).

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2009-09-30
Completion
2009-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00867100 on ClinicalTrials.gov