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Study to Evaluate Safety and Efficacy of CCX 354-C in Subjects With Rheumatoid Arthritis

NCT01027728 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-03-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and tolerability of multiple oral doses of CCX354-C at a number of dose levels in subjects with stable rheumatoid arthritis (RA).

Conditions

Interventions

DRUG

CCX 354-C

* Cohort 1: Eight subjects will be randomized to receive 100 mg CCX354-C or placebo in a ratio of 3:1 (CCX354-C:placebo) once daily for 14 days; * Cohort 2: Eight subjects will be randomized to receive 100 mg CCX354-C or placebo in a ratio of 3:1 (CCX354-C:placebo) twice daily for 14 days; and * Cohort 3: Eight subjects will be randomized to receive 200 mg CCX354-C or placebo in a ratio of 3:1 (CCX354-C:placebo) once daily for 14 days.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • Belgium
  • Romania

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT01027728 on ClinicalTrials.gov