Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Dose CFZ533 in Rheumatoid Arthritis Patients

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Biological: CFZ533; Drug: Placebo

• Registration Number: NCT02089087
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This is a first-in-human study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single intravenous and subcutaneous doses of CFZ533 in healthy subjects and intravenous doses in rheumatoid arthritis patients.

Detailed Description

This was a Healthy Volunteer only study originally, but after an amendment to protocol, rheumatoid arthritis patients will be starting 7-Mar-2014 and thus, the protocol is now registered.

Study Timeline

• Study Start: 2013-01-07
• Study First Submitted: 2014-03-13
• Study First Submitted QC: 2014-03-13
• Study First Posted: 2014-03-17
• Primary Completion: 2017-02-03
• Study Completion: 2017-02-03
• Status Verified: 2019-03
• Last Update Submitted: 2020-12-09
• Last Update Posted: 2020-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CFZ533 in healthy volunteers	CFZ533	CFZ533 single dose in healthy volunteers
CFZ533 in rheumatoid arthritis patients	CFZ533	CFZ533 single dose in rheumatoid arthritis patients
Placebo	Placebo	Placebo single dose

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse events as a measure of safety and tolerability	7 months

Secondary Outcome Measures

Name	Time	Method
Plasma Pharmacokinetics (PK) of CFZ533: Area Under the Plasma Concentration-time Curve (AUC)	6 months	The following PK parameters were determined from the plasma concentration time profile of CFZ533 using a non-compartmental method: AUCtau: Area under the plasma concentration-time curve from time zero to the end of the dosing interval; AUClast: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration; AUCinf: Area under the plasma concentration-time curve from time zero to infinity
Plasma Pharmacokinetics (PK) of CFZ533: Systemic Clearance from Plasma (CL)	6 months
CFZ533 immunogenicity	6 months	Determining the presence and measuring amount of anti-CFZ533 antibodies in the blood
Plasma Pharmacokinetics (PK) of CFZ533: Observed Maximum Plasma Concentration Following Drug Administration (Cmax)	6 months
Plasma Pharmacokinetics (PK) of CFZ533: Apparent Volume of Distribution (Vss)	6 months

Trial Locations

Locations (1)

Novartis Investigative Site; 🇨🇳 Taipei, Taiwan