48
Participants
Start Date
March 14, 2025
Primary Completion Date
September 30, 2025
Study Completion Date
September 30, 2025
CBT101
"Part 1 (SAD): at the morning~* Cohort 1: 1 puff in each nostril (total 2 puffs), total 4.2 mg~* Cohort 2: 2 puffs in each nostril (total 4 puffs), total 8.4 mg~* Cohort 3: 3 puffs in each nostril (total 6 puffs), total 12.6 mg~Part 2 (MAD):~* Cohort 4: 1 puff per nostril/day (total 2 puffs/day), total 4.2 mg/day (morning)~* Cohort 5: 2 puffs per nostril/day (total 4 puffs/day), total 8.4 mg/day (morning and evening)~* Cohort 6: 3 puffs per nostril/day (total 6 puffs/day), total 12.6 mg/day (morning, midday and evening)"
Placebo
"Part 1 (SAD): at the morning~* Cohort 1: 1 puff in each nostril (total 2 puffs), total 4.2 mg~* Cohort 2: 2 puffs in each nostril (total 4 puffs), total 8.4 mg~* Cohort 3: 3 puffs in each nostril (total 6 puffs), total 12.6 mg~Part 2 (MAD):~* Cohort 4: 1 puff per nostril/day (total 2 puffs/day), total 4.2 mg/day (morning)~* Cohort 5: 2 puffs per nostril/day (total 4 puffs/day), total 8.4 mg/day (morning and evening)~* Cohort 6: 3 puffs per nostril/day (total 6 puffs/day), total 12.6 mg/day (morning, midday and evening)"
RECRUITING
Eurofins Optimed, Gières
Lead Sponsor
Eurofins Optimed
INDUSTRY
Ceres Brain Therapeutics
OTHER