A Randomized, Double-blind, Placebo-controlled Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Single Intravenous and Subcutaneous Doses of GZ402668 in Men and Women With Progressive Multiple Sclerosis
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Number of participants with treatment emergent adverse events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Dose 1 IV
GZ402668 dose 1 intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy
Intervention: acyclovir (Drug)
Dose 2 IV
GZ402668 dose 2 intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy
Intervention: GZ402668 (Drug)
Dose 3 SC
GZ402668 dose 3 subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy
Intervention: acyclovir (Drug)
Dose 1 IV
GZ402668 dose 1 intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy
Intervention: GZ402668 (Drug)
Dose 2 IV
GZ402668 dose 2 intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy
Intervention: acyclovir (Drug)
Dose 3 IV
GZ402668 dose 3 intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy
Intervention: GZ402668 (Drug)
Dose 3 IV
GZ402668 dose 3 intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy
Intervention: acyclovir (Drug)
Dose 3 SC
GZ402668 dose 3 subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy
Intervention: GZ402668 (Drug)
Dose 4 SC
GZ402668 dose 4 subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy
Intervention: GZ402668 (Drug)
Dose 4 SC
GZ402668 dose 4 subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy
Intervention: acyclovir (Drug)
Dose 5 SC
GZ402668 dose 5 subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy
Intervention: GZ402668 (Drug)
Dose 5 SC
GZ402668 dose 5 subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy
Intervention: acyclovir (Drug)
Placebo SC
placebo subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy
Intervention: placebo (Drug)
Placebo SC
placebo subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy
Intervention: acyclovir (Drug)
Placebo IV
placebo intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy
Intervention: placebo (Drug)
Placebo IV
placebo intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy
Intervention: acyclovir (Drug)
Outcomes
Primary Outcomes
Number of participants with treatment emergent adverse events
Time Frame: 4 weeks
Secondary Outcomes
- 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)