Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VT7208 in Healthy Participants and MS Patients
Recruiting · NCT07085507 · Interventional (participants receive a specific treatment) · Lead sponsor: Vidya Therapeutics Inc
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboVT7208
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →