Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LYT-300 · 1 trial · 1 indication
Evaluate the safety and tolerability in healthy volunteers following single or multiple oral doses of LYT-300 as measured by TEAEs.
Measure concentration of allopregnanolone in blood plasma in fed or fasted subjects administered a single dose of LYT-300
Change in salivary cortisol
| Arm | Type | Description |
|---|---|---|
| LYT-300 in healthy volunteers LYT-300, Doses TBD | EXPERIMENTAL | Subjects will crossover across 3 dosing periods in which they will receive placebo and two experimental dose levels |
| LYT-300 in healthy volunteers LYT-300 | EXPERIMENTAL | LYT-300, Dose TBD with and without food, separated by 7-day washout |
| LYT-300, Dose TBD QAM every 24 h for 7 days | EXPERIMENTAL | - |
| Placebo QAM every 24 h for 7 days | PLACEBO_COMPARATOR | - |
| Placebo QHS every 24 h for 7 days | PLACEBO_COMPARATOR | - |
| LYT-300 in healthy volunteers LYT-300, Dose TBD QHS every 24 h for 7 days | EXPERIMENTAL | - |
| LYT-300 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| LYT-300 | DRUG | A prodrug of allopregnanolone, a small molecule drug |
| Placebo | OTHER | Placebo for LYT-300 |
Main Inclusion Criteria: Parts 1, 2, 3 and 4: Healthy Volunteers 1. Male or female between 18 and 55 years old (inclusive) at the time of screening. 2. In good general health at screening, free from clinically significant unstable medical, surgical or psychiatric illness, at the discretion of the ...
LYT-300 is an investigational small-molecule drug developed by PureTech Health plc. It is designed to deliver allopregnanolone, a hormone, and has been studied in a Phase 1/Phase 2 trial in healthy volunteers. It remains in clinical development and is not approved for any use.
LYT-300 targets allopregnanolone, a hormone. The drug is a small molecule intended to deliver allopregnanolone, and its clinical program has focused on measuring how the body handles this hormone in healthy volunteers rather than in a patient population.
LYT-300 is being developed by PureTech Health plc, which trades under the ticker PRTCY. PureTech Health is the company behind the LYT-300 program, which has advanced through a completed Phase 1/Phase 2 study in healthy volunteers.
LYT-300 is in Phase 1/Phase 2 development. Its single registered trial, NCT05129865, has completed, and no trials are currently listed as active. LYT-300 is investigational and has not been approved by the FDA for any indication.
LYT-300 has been studied in one clinical trial, NCT05129865, titled LYT-300 in Healthy Volunteers. It was a Phase 1/Phase 2 randomized, double-blind, placebo-controlled study that enrolled 186 healthy volunteers aged 18 and older in Australia and has completed.