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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07085507




Registration number
NCT07085507
Ethics application status
Date submitted
7/07/2025
Date registered
25/07/2025
Date last updated
3/09/2025

Titles & IDs
Public title
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VT7208 in Healthy Participants and MS Patients
Scientific title
A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose Escalation Study in Healthy Participants and an Expansion Cohort in Adult Patients With Multiple Sclerosis to Characterize the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VT7208
Secondary ID [1] 0 0
VT7208-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - VT7208
Treatment: Drugs - Placebo

Experimental: Part 1 SAD Cohorts: Active drug - Participants will receive a single dose of VT7208 in a dose escalation format.

Placebo comparator: Part 1 SAD Cohorts: Placebo - Healthy volunteers will receive a single dose of placebo

Experimental: 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

Placebo comparator: Part 1 MAD Cohort: Placebo - Healthy volunteers will receive repeated doses of placebo comparator.

Experimental: 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.

Experimental: 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.


Treatment: Drugs: VT7208
a small synthetic molecule capsule, oral

Treatment: Drugs: Placebo
capsule, oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of VT7208 in healthy volunteers and patients with MS
Timepoint [1] 0 0
Up to 16 weeks
Secondary outcome [1] 0 0
Part 1: Pharmacokinetics of a single dose of VT7208 in healthy adults
Timepoint [1] 0 0
up to 2 weeks
Secondary outcome [2] 0 0
Part 1: Pharmacodynamics (PD) of a single dose of VT7208 in healthy adults
Timepoint [2] 0 0
up to 2 weeks
Secondary outcome [3] 0 0
Part 1: Pharmacokinetics of multiple doses of VT7208 in healthy adults and in patients with MS
Timepoint [3] 0 0
up to 2 weeks
Secondary outcome [4] 0 0
Part 1: Pharmacodynamics (PD) of multiple doses of VT7208 in healthy adults and in patients with MS
Timepoint [4] 0 0
up to 2 weeks
Secondary outcome [5] 0 0
Part 2: Pharmacokinetics of VT7208 in healthy adults fed and fasted
Timepoint [5] 0 0
up to 2 weeks
Secondary outcome [6] 0 0
Part 2: Pharmacodynamics (PD) of VT7208 in healthy adults fed and fasted
Timepoint [6] 0 0
up to 2 weeks
Secondary outcome [7] 0 0
Characterize the ability of VT7208 to cross the blood brain barrier in healthy adults and in patients with MS
Timepoint [7] 0 0
Up to 16 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Vidya Therapeutics Inc
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Vidya Therapeutics Australia Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
MIchele DeSciscio, MBSS
Address 0 0
Country 0 0
Phone 0 0
+61 (0) 422 447 902
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07085507