Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VT7208 · 1 trial · 1 indication
To assess the incidence, nature, and relationship of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) in healthy adults following a single dose.
To assess the incidence, nature, and relationship of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) in healthy adults following multiple daily doses.
To assess the incidence, nature, and relationship of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) in patients with Multiple Sclerosis (MS).
| Arm | Type | Description |
|---|---|---|
| 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 | EXPERIMENTAL | Open label cohort to be administered to patients with MS. Dose for this part will be determined from parts 1 and 2. |
| Name | Type | Description |
|---|---|---|
| VT7208 | DRUG | a small synthetic molecule capsule, oral |
| Placebo | DRUG | capsule, oral |
Inclusion Criteria: 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 ...
VT7208 is an investigational small molecule being developed for the treatment of Multiple Sclerosis (MS). It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities. The drug is being studied to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy participants and MS patients.
VT7208 is being developed by Processa Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol PCSA. The company is conducting clinical trials to evaluate the drug's potential as a treatment for Multiple Sclerosis.
VT7208 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is recruiting participants to assess the drug's safety, tolerability, and how it is processed by the body.
VT7208 is being studied in a Phase 1 clinical trial registered as NCT07085507. This trial is titled 'Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VT7208 in Healthy Participants and MS Patients' and is currently recruiting participants in Australia. The study plans to enroll approximately 100 participants.
No, VT7208 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials. The drug is being studied for the treatment of Multiple Sclerosis, but it has not yet completed the clinical development process required for regulatory approval.
Yes, VT7208 is being tested in healthy volunteers as part of its Phase 1 clinical trial. The study, NCT07085507, is designed to include both healthy participants and patients with Multiple Sclerosis. This approach is common in early-phase trials to establish safety and dosing before testing in larger patient populations.