Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MTX325 · 1 trial · 3 indications
To assess the safety and tolerability of single ascending doses of MTX325, when administered to participants. Adverse Events will be collected. The following vital signs will be measured to form the safety and tolerability outcome- blood pressure, heart rate, oral body temperature, respiratory rate. Laboratory Safety analyses will include biochemistry, haematology, and urinalysis. 12-lead ECG will be performed to collect heart rate, RR interval, PR interval, QRS width, QT interval, and QTcF interval. All participants who receive at least 1 dose of IMP will be included in the safety analysis.
To investigate the brain biodistribution in MTX325. This part of the protocol is intended to ascertain the biodistribution of MTX325 in the brain. Radiolabelled MTX325 will be injected and PET images taken to determine the whole brain and regions of interest distribution volume. MRI images will be performed to be able to co-register regions of interest.
| Arm | Type | Description |
|---|---|---|
| Parts 1 - 4 | ACTIVE_COMPARATOR | MTX325 Active Oral Capsules - 1.5mg - 100mg These 4 parts are SAD, MAD, Elderly and PET biodistribution. |
| Parts 1 - 3, and 5 | PLACEBO_COMPARATOR | MTX325 Placebo Capsules - 50mg. Parts 1-3 are SAD, MAD and Elderly cohorts. Matched strength placebo capsules in Part 5 (PD participants) |
| Part 4 | ACTIVE_COMPARATOR | MTX325 Capsules - 20mg. Radiolabelled MTX325 solution for injection. This is a healthy volunteer PET study. Not placebo controlled. |
| Part 5 | ACTIVE_COMPARATOR | MTX325 - 20 mg Capsules |
| Name | Type | Description |
|---|---|---|
| MTX325 | DRUG | MTX325 |
| Placebo | OTHER | Placebo |
PART 5 - Currently recruiting in Parkinson's Disease Patients Inclusion Criteria 1. Male and female participants aged ≥ 40 to ≤ 75 years. 2. Male or female participants. Female participants of childbearing potential must be willing to use highly effective forms of contraception (refer to Section 9...