A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose Escalation Study in Healthy Participants and an Expansion Cohort in Adult Patients With Multiple Sclerosis to Characterize the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VT7208
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
Part 1 of this study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VT7208 in healthy volunteers. Part 2 of this study will be an open-label, randomized study to characterize the effect of food on the pharmacokinetics of VT7208 in healthy volunteers. Part 3 of this study will evaluate the safety of VT7208 as monotherapy in patients with MS.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:
⁃ Parts 1 and 2
• Age 18-65
• Must be in good health with no significant medical history
• Willing and able to attend all study visits and comply with study requirements, including lumbar puncture for CSF collection
• Able and willing to provide written informed consent
⁃ Part 3
• Age 18-60
• Must be in good health with no significant medical history
• MS diagnosis prior to Day 1 in accordance with 2017 McDonald criteria.
• Willing and able to attend all study visits and comply with study requirements, including lumbar puncture for CSF collection
• Able and willing to provide written informed consent
Locations
Other Locations
Australia
CMAX
RECRUITING
Adelaide
Contact Information
Primary
MIchele DeSciscio, MBSS
Michele.DeSciscio@cmax.com.au
+61 (0) 422 447 902
Time Frame
Start Date:2025-08-01
Estimated Completion Date:2027-12-31
Participants
Target number of participants:100
Treatments
Experimental: Part 1 SAD Cohorts: Active drug
Participants will receive a single dose of VT7208 in a dose escalation format.
Placebo_comparator: Part 1 SAD Cohorts: Placebo
Healthy volunteers will receive a single dose of placebo
Experimental: Part 1 MAD Cohort: Active drug
Healthy volunteers will receive repeated doses of VT7208. Dose to be determined based on escalation data from SAD Cohorts
Placebo_comparator: Part 1 MAD Cohort: Placebo
Healthy volunteers will receive repeated doses of placebo comparator.
Experimental: Part 2: Food Effect
Open label randomized cohort to be administered to healthy volunteers. Participants will be randomized to receive dose in either fasted or fed state. Dose to be determined from data of SAD and MAD cohorts.
Experimental: Part 3: Patients with Multiple Sclerosis
Open label cohort to be administered to patients with MS. Dose for this part will be determined from parts 1 and 2.