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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VT7208 in Healthy Participants and MS Patients

RecruitingPhase 1, Phase 2

Sponsor: Vidya Therapeutics Inc

Conditions: Multiple Sclerosis

Interventions: VT7208, Placebo

Countries: Australia

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 overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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

* 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

Exclusion Criteria:

* Evidence of clinically significant condition or disease
* Any physical or psychological condition that prohibits study completion
* Known history of illicit drug use or drug abuse, harmful alcohol use (at the -Investigator's discretion), alcoholism, and/or smoking or nicotine-containing product use within 7 days prior to the first dose of study agent
* History of severe allergic reactions or hypersensitivity
* Donation or loss of ≥ 1 unit of whole blood or plasma within 4 weeks prior to dosing

Locations (1)

Adelaide, South Australia, Australia