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

NCT ID: NCT07085507

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2027-12-31

Brief Summary

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.

Detailed 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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Part 1 SAD Cohorts: Active drug

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

Group Type: EXPERIMENTAL

VT7208

Intervention Type: DRUG

a small synthetic molecule capsule, oral

Part 1 SAD Cohorts: Placebo

Healthy volunteers will receive a single dose of placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

capsule, oral

Part 1 MAD Cohort: Active drug

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

Group Type: EXPERIMENTAL

VT7208

Intervention Type: DRUG

a small synthetic molecule capsule, oral

Part 1 MAD Cohort: Placebo

Healthy volunteers will receive repeated doses of placebo comparator.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

capsule, oral

Part 2: Food Effect

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.

Group Type: EXPERIMENTAL

VT7208

Intervention Type: DRUG

a small synthetic molecule capsule, oral

Part 3: Patients with Multiple Sclerosis

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

Group Type: EXPERIMENTAL

VT7208

Intervention Type: DRUG

a small synthetic molecule capsule, oral

Interventions

VT7208

a small synthetic molecule capsule, oral

Intervention Type: DRUG

Placebo

capsule, oral

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vidya Therapeutics Australia Pty Ltd

UNKNOWN

Sponsor Role: collaborator

Vidya Therapeutics Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CMAX

Adelaide, South Australia, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

MIchele DeSciscio, MBSS

Role: CONTACT

Michele.DeSciscio@cmax.com.au

+61 (0) 422 447 902

Facility Contacts

Katherine Mudge

Role: primary

katherine.mudge@cmax.com.au

+61 (0)8 7088 7900

Other Identifiers

VT7208-101

Identifier Type: -

Identifier Source: org_study_id