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

Vidya Therapeutics Inc

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Multiple Sclerosis

Treatments: Drug: VT7208; Drug: Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07085507

VT7208-101

Details and patient eligibility

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 6 patient groups, including a placebo group

Part 1 SAD Cohorts: Active drug

Experimental group

Description:

Participants will receive a single dose of VT7208 in a dose escalation format.

Treatment:

Drug: VT7208

Part 1 SAD Cohorts: Placebo

Placebo Comparator group

Description:

Healthy volunteers will receive a single dose of placebo

Treatment:

Drug: Placebo

Part 1 MAD Cohort: Active drug

Experimental group

Description:

Healthy volunteers will receive repeated doses of VT7208. Dose to be determined based on escalation data from SAD Cohorts

Treatment:

Drug: VT7208

Part 1 MAD Cohort: Placebo

Placebo Comparator group

Description:

Healthy volunteers will receive repeated doses of placebo comparator.

Treatment:

Drug: Placebo

Part 2: Food Effect

Experimental group

Description:

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.

Treatment:

Drug: VT7208

Part 3: Patients with Multiple Sclerosis

Experimental group

Description:

Open label cohort to be administered to patients with MS. Dose for this part will be determined from parts 1 and 2.

Treatment:

Drug: VT7208