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| Name | Class |
|---|---|
| Vidya Therapeutics Australia Pty Ltd | UNKNOWN |
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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.
This study is a Phase 1/2 randomized, double-blind, placebo-controlled, single- and multiple-dose study with staggered dose escalations in healthy participants.
Following completion of SAD and MAD cohorts, healthy volunteers will participate in administration of VT7208 with and without food to determine the effect of a fasted or fed state on pharmacokinetics.
Participants with MS will be recruited for part 3 of this study.
This study consists of 3 parts, as follows:
Part 1: SAD in healthy volunteers with a single dose administration of VT7208 or placebo and collection of study data.
MAD in healthy volunteers with multiple dose administration of VT7208 or placebo and collection of study data.
Part 2:
Food effect cohort in healthy volunteers. Participants will be randomized to receive open label VT7208 in either a fasted state or a fed state, and will receive the opposite at the next admission to the study site.
Part 3:
Participants MS will receive VT7208 with dose determined from Parts 1 and 2. Participation in this section will entail weekly study visits for administration of study medication collection of study data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 SAD Cohorts: Active drug | Experimental | Participants will receive a single dose of VT7208 in a dose escalation format. |
|
| Part 1 SAD Cohorts: Placebo | Placebo Comparator | Healthy volunteers will receive a single dose of placebo |
|
| Part 1 MAD Cohort: Active drug | Experimental | Healthy volunteers will receive repeated doses of VT7208. Dose to be determined based on escalation data from SAD Cohorts |
|
| Part 1 MAD Cohort: Placebo | Placebo Comparator | Healthy volunteers will receive repeated doses of placebo comparator. |
|
| Part 2: Food Effect | Experimental | 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. |
|
| Part 3: Patients with Multiple Sclerosis |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VT7208 | Drug | a small synthetic molecule capsule, oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of VT7208 in healthy volunteers and patients with MS | Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) | Up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Pharmacokinetics of a single dose of VT7208 in healthy adults | Pharmacokinetic parameter of CMAX of VT7208 in the blood of healthy adults | up to 2 weeks |
| Part 1: Pharmacodynamics (PD) of a single dose of VT7208 in healthy adults |
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Inclusion Criteria:
Parts 1 and 2
Part 3
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MIchele DeSciscio, MBSS | Contact | +61 (0) 422 447 902 | Michele.DeSciscio@cmax.com.au |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX | Recruiting | Adelaide | South Australia | 5000 | Australia |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Experimental |
Open label cohort to be administered to patients with MS. Dose for this part will be determined from parts 1 and 2. |
|
| Placebo | Drug | capsule, oral |
|
BTK inhibition as measured by free, total and phosphorylated BTK level in blood
| up to 2 weeks |
| Part 1: Pharmacokinetics of multiple doses of VT7208 in healthy adults and in patients with MS | Pharmacokinetic parameter of CMAX of VT7208 in the blood of healthy adults | up to 2 weeks |
| Part 1: Pharmacodynamics (PD) of multiple doses of VT7208 in healthy adults and in patients with MS | BTK inhibition as measured by free, total and phosphorylated BTK level in blood | up to 2 weeks |
| Part 2: Pharmacokinetics of VT7208 in healthy adults fed and fasted | Pharmacokinetic parameter of CMAX of VT7208 in the blood | up to 2 weeks |
| Part 2: Pharmacodynamics (PD) of VT7208 in healthy adults fed and fasted | BTK inhibition as measured by free, total and phosphorylated BTK level in blood of healthy adults fed and fasted | up to 2 weeks |
| Characterize the ability of VT7208 to cross the blood brain barrier in healthy adults and in patients with MS | Ability of VT7208 to cross the blood brain barrier will be measured in cerebrospinal fluid (CSF). This will be collected during admitted study visits for healthy volunteers | Up to 16 weeks |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |