LYT-300 in Healthy Volunteers

Part 1: This is a randomized, double-blind, placebo-controlled, SAD design to assess the safety, tolerability, and PK profile of orally administered LYT-300 in HV, in a 3-period, 3-sequence, crossover, dose escalation design.

Part 2: This is a randomized, open label, 3-period, 3-sequence, crossover assessment of the effects of food on the PK, safety, and tolerability of orally administered LYT-300 in HV. A single dose of LYT-300 will be administered on 3 occasions, separated by a minimum 7-day washout period. Part 2 is planned as a single dosing cohort.

Part 3: This is a randomized, double-blind, placebo-controlled, sequential, MAD trial in HV to assess the safety, tolerability, and PK profile of multiple doses (up to 7 days) of orally administered LYT-300. This part will include ascending doses given either once daily in the morning (QAM), once daily in the evening (QHS), or twice daily (BID).

Part 4: This is a double-blind, randomized assessment of the effects in HV of a single dose of LYT-300 vs. placebo on pharmacodynamic and patient reported outcome response to a validated clinical model of anxiety.

Main Inclusion Criteria:

Parts 1, 2, 3 and 4: Healthy Volunteers

• Male or female between 18 and 55 years old (inclusive) at the time of screening.
• In good general health at screening, free from clinically significant unstable medical, surgical or psychiatric illness, at the discretion of the Investigator.

Main Exclusion Criteria:

Parts 1, 2, 3 and 4: Healthy Volunteers

• Evidence or history of any condition or situation that adversely impacts a normal sleep-wake cycle.
• Confirmed COVID-19 infection within 2 months of screening, known exposure to another person with COVID-19 within 14 days of screening
• History of illness with fever within 28 days prior to the first dose.
• A history of, or current evidence for, serious mental illness