A Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis
NCT02977533 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2022-04-25
Summary
Primary Objective:
To assess the safety and tolerability of GZ402668 after a single subcutaneous (SC) dose in men and women with progressive multiple sclerosis.
Secondary Objectives:
To assess in men and women with progressive multiple sclerosis:
* The pharmacokinetic (PK) parameters of GZ402668 after a single SC dose.
* The pharmacodynamic (PD) response to GZ402668 after a single SC dose.
Conditions
Interventions
- DRUG
-
GZ402668
Pharmaceutical form: solution Route of administration: subcutaneous
- DRUG
-
Pharmaceutical form: solution Route of administration: subcutaneous
- DRUG
-
Acyclovir
Pharmaceutical form: tablet Route of administration: oral
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Sciences & Operations · Sanofi
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-12-01
- Primary Completion
- 2018-05-16
- Completion
- 2018-05-16
Countries
- Germany
Study Locations
More Related Trials
-
A First Time in Human Study Exploring Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK2618960 in Healthy Volunteers and Patients With Relapsing Remitting Multiple Sclerosis (RRMS)
NCT01808482 ·Status: TERMINATED ·Phase: PHASE1
-
A Study to Characterize Subcutaneous or Intravenous Alemtuzumab in Patients With Progressive Multiple Sclerosis
NCT02583594 ·Status: COMPLETED ·Phase: PHASE1
-
IDP-023 g-NK Cells Plus Ocrelizumab in Patients With Progressive Multiple Sclerosis
NCT06677710 ·Status: SUSPENDED ·Phase: PHASE1
-
A Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Participants With Multiple Sclerosis
NCT03972306 ·Status: COMPLETED ·Phase: PHASE1
-
Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers
NCT03574428 ·Status: COMPLETED ·Phase: PHASE1
-
GSK2018682 FTIH in Healthy Volunteers
NCT01387217 ·Status: COMPLETED ·Phase: PHASE1
-
Multiple Doses of Anti-NOGO A in Relapsing Forms of Multiple Sclerosis
NCT01435993 ·Status: TERMINATED ·Phase: PHASE1
-
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)
NCT04548999 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-248
NCT04036227 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Participants With Relapsing Multiple Sclerosis (RMS) or Primary Progressive Multiple Sclerosis (PPMS)
NCT02688985 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Assess the Relative Bioavailability of Different Formulations of GSK2018682, a Sphingosine-1-phosphate Receptor Subtype 1 Agonist, in Healthy Volunteers.
NCT01466322 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Safety of Administering Ocrelizumab Per a Shorter Infusion Protocol in Participants With Primary Progressive Multiple Sclerosis (PPMS) and Relapsing Multiple Sclerosis (RMS)
NCT03606460 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)
NCT04544436 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Safety, Tolerability, and Effectiveness of CGP77116 in Patients With Multiple Sclerosis (MS)
NCT00001781 ·Status: COMPLETED ·Phase: PHASE2
-
People With Multiple Sclerosis Treated With Ocrelizumab and GLP-1 Agonists
NCT07207148 ·Status: RECRUITING
-
Efficacy and Safety of 4-aminopyridine on Cognitive Performance and Motor Function of Patients With Multiple Sclerosis
NCT02280096 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis
NCT05232825 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of Safety, Tolerability, and PK of VX15/2503 In Patients With MS
NCT01764737 ·Status: COMPLETED ·Phase: PHASE1
-
First-in-Human Study With GNbAC1 in Healthy Volunteers
NCT01699555 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of GB261 in Systemic Sclerosis
NCT07159009 ·Status: NOT_YET_RECRUITING ·Phase: EARLY_PHASE1
-
Study Of SB-683699 Compared To Placebo In Subjects With Relapsing-Remitting Multiple Sclerosis (MS)
NCT00395317 ·Status: COMPLETED ·Phase: PHASE2
-
Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis
NCT00097331 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years
NCT06735248 ·Status: RECRUITING ·Phase: PHASE2
-
Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Patients With Multiple Sclerosis
NCT01933802 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of MD1003 in Spinal Progressive Multiple Sclerosis
NCT02220933 ·Status: UNKNOWN ·Phase: PHASE3