LYT-300 in Healthy Volunteers
Summary
Part 1 is a single ascending dose (SAD) trial in healthy volunteers (HV) to assess the safety, tolerability, and pharmacokinetic (PK) profile of orally administered LYT-300. Part 2 is a crossover assessment in HV of the effects of food on the safety, tolerability, and PK profile of orally administered LYT-300. Part 3 is a multiple ascending dose (MAD) trial in HV to assess the safety, tolerability, and PK profile of multiple doses (up to 7 days) of orally administered LYT-300. Part 4 is an assessment of the effects of LYT-300 vs. placebo on pharmacodynamic and patient reported outcome response to a validated clinical model of anxiety.
Timeline
- Start
- 2021-12-07
- Primary completion
- 2023-10-18
- Completion
- 2023-10-23
Outcome
Met primary endpoint
release “The trial met its primary endpoint, demonstrating that evening dosing of GlyphAllo at 375 mg did not impair” puretechhealth.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LYT-300 | Unknown | — | Oral |
Indications
No indication recorded.