A First-in-human, Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis
- Conditions
- Progressive Multiple Sclerosis
- Interventions
- Registration Number
- NCT02282826
- Lead Sponsor
- Genzyme, a Sanofi Company
- Brief Summary
Primary Objective:
To assess the safety and tolerability of GZ402668 after ascending single intravenous (IV) and subcutaneous (SC) doses in men and women with progressive multiple sclerosis.
Secondary Objectives:
To assess the following in men and women with progressive multiple sclerosis:
* The pharmacokinetic (PK) parameters of GZ402668 after ascending single IV doses.
* The pharmacodynamics (PD) of GZ402668 after ascending single IV doses.
* The PK parameters of GZ402668 after ascending single SC doses.
* The PD of GZ402668 after ascending single SC doses.
- Detailed Description
The total study duration from screening for a patient can be approximately up to 8 weeks.
Upon completion of this trial, patients treated with GZ402668 will be required to enroll in a 4 year safety follow-up study for continued safety observation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dose 1 IV GZ402668 GZ402668 dose 1 intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy Dose 2 IV GZ402668 GZ402668 dose 2 intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy Dose 3 IV GZ402668 GZ402668 dose 3 intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy Dose 3 SC GZ402668 GZ402668 dose 3 subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy Dose 4 SC GZ402668 GZ402668 dose 4 subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy Dose 5 SC GZ402668 GZ402668 dose 5 subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy Placebo SC placebo placebo subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy Placebo IV placebo placebo intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy Dose 1 IV acyclovir GZ402668 dose 1 intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy Dose 2 IV acyclovir GZ402668 dose 2 intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy Dose 3 IV acyclovir GZ402668 dose 3 intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy Dose 3 SC acyclovir GZ402668 dose 3 subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy Dose 4 SC acyclovir GZ402668 dose 4 subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy Dose 5 SC acyclovir GZ402668 dose 5 subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy Placebo SC acyclovir placebo subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy Placebo IV acyclovir placebo intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy
- Primary Outcome Measures
Name Time Method Number of participants with treatment emergent adverse events 4 weeks
- Secondary Outcome Measures
Name Time Method Number of participants with lymphocyte depletion 4 weeks Number of participants with injection site reactions 2 weeks maximum concentration (Cmax) 4 weeks area under curve (AUC) 4 weeks Number of participants with anti-drug antibodies 4 weeks Number of participants with corrected QT interval (QTcF) prolongation 4 weeks
Trial Locations
- Locations (1)
Investigational Site Number 276001
🇩🇪Berlin, Germany