Intranasal Administration of Dodecyl Creatine Ester (CBT101) in Healthy Male Subjects

PHASE1RecruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

March 14, 2025

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2025

Conditions
Neurologic Diseases, General
Interventions
DRUG

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)"

DRUG

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)"

Trial Locations (1)

38610

RECRUITING

Eurofins Optimed, Gières

Sponsors
All Listed Sponsors
collaborator

Eurofins Optimed

INDUSTRY

lead

Ceres Brain Therapeutics

OTHER