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

NCT07050316 | Completed Phase 1

• 2 other identifiers: CBT101 / OP112923.CER2024-515549-40-00
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 1, Randomized, Double-Blinded, Placebo-Controlled study to Evaluate the Safety, Tolerability,and Pharmacokinetics of Single and Multiple Ascending Doses of CBT101 given intranasally in Healthy Male Subjects.

Conditions

Neurologic Diseases, General

Outcome Measures

Primary Outcomes (12)

• Part 1 : Safety and tolerability assessment:

  \- Adverse events /treatment-emergent adverse events (TEAEs)

  From screening to the last visit (4weeks)

• Part 2 : Safety and tolerability assessment

  \- Adverse events /treatment-emergent adverse events (TEAEs);

  From screening to the last visit (6 weeks)

• Part 1 : Safety and tolerability assessment:

  Change in nasal examination, including anterior rhinoscopy over the study

  From screening to the last visit (4weeks)

• Part 1 : Safety and tolerability assessment:

  \- Change in physical examination and body weight over the study course as compared to baseline;weight and height will be combined to report BMI in kg/m\^2

  From screening to the last visit (4weeks)

• Part 1 : Safety and tolerability assessment:

  \- Change in clinical laboratory evaluations (including hematology, biochemistry, , urinalysis) over the study course as compared to baseline;

  From screening to the last visit (4weeks)

• Part 1 : Safety and tolerability assessment:

  \- Change in vital signs assessment over the study course as compared to baseline;

  From screening to the last visit (4weeks)

• Part 1 : Safety and tolerability assessment:

  \- Change in 12-lead ECG, over the study course as compared to baseline : QRS, PR and QTcf.

  From screening to the last visit (4weeks)

• Part 2 : Safety and tolerability assessment

  \- Change in nasal examination, including rhinoscopy over the study course as compared to baseline;

  From screening to the last visit (6 weeks)

• Part 2 : Safety and tolerability assessment

  \- Change in physical examination and body weight over the study course as compared to baseline;weight and height will be combined to report BMI in kg/m\^2

  From screening to the last visit (6 weeks)

• Part 2 : Safety and tolerability assessment

  \- Change in clinical laboratory evaluations (including hematology, biochemistry, , urinalysis) over the study course as compared to baseline;

  From screening to the last visit (6 weeks)

• Part 2 : Safety and tolerability assessment

  \- Change in vital signs assessment over the study course as compared to baseline;

  From screening to the last visit (6 weeks)

• Part 2 : Safety and tolerability assessment

  \- Change in 12-lead ECG, over the study course as compared to baseline : PR, QRS and QTcf

  From screening to the last visit (6 weeks)

Secondary Outcomes (24)

• Part 1 : Plasma pharmacokinetics assessment of CBT101

  From screening to the day 2 (3 weeks)

• Part 1 : The metabolites 1-dodecanol will be determined and several PK parameters will be calculated.

  From screening to the day 2 (3 weeks)

• Part 1 : Plasma pharmacokinetics assessment of CBT101

  From screening to the day 2 (3 weeks)

• Part 1 : Plasma pharmacokinetics assessment of CBT101

  From screening to the day 2 (3 weeks)

• Part 1 : Plasma pharmacokinetics assessment of CBT101

  From screening to the day 2 (3 weeks)

Other Outcomes (12)

• Part 1 : To evaluate the CNS effect on qEEG of CBT101

  One day

• Part 1: To assess the neuro-cognitive performance of CBT101

  2 days

• Part 2 : To evaluate the CNS effect on ERP P300 of CBT101

  13 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects will receive placebo : For Part 1 (SAD): Single administration on D1 for cohorts 1, 2 and 3. For Part 2 (MAD): Repeated administration from D1 to D14.

Drug: Placebo

CBT101

EXPERIMENTAL

Subjects will receive the CBT101: For Part 1 (SAD): Single administration on D1 for cohorts 1, 2 and 3. For Part 2 (MAD): Repeated administration from D1 to D14.

Drug: CBT101

Interventions

CBT101 DRUG

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)

CBT101

Placebo DRUG

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male aged to 18-55 years inclusive;
• Must agree to adhere to the contraception requirements: use of condom by the male subject plus an effective method of contraception for the subject partner of childbearing potential from the time of informed consent signature up to 3 months after last administration. Highly effective method of birth control such as combined hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intra uterine devices (IUDs), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion) In accordance with CTFG guidelines;
• Non-smoker subject or smoker of not more than 5 cigarettes a day who stops smoking at least 1 week before the Screening;
• Body Mass Index (BMI) between 18,0 and 30,0 (kg/m2) inclusive, with body weight between 50 and 95 kg inclusive, at Screening and Day -1;
• Considered as healthy after a comprehensive clinical assessment (detailed medical history and complete physical examination);
• Normal Blood Pressure (BP), and Heart Rate (HR) at the screening visit after 10 minutes in supine position:
• mmHg ≤ Systolic Blood Pressure (SBP) ≤ 140 mmHg,
• mmHg ≤ Diastolic Blood Pressure (DBP) ≤ 90 mmHg,
• bpm ≤ HR ≤ 90 bpm,
• Or considered NCS by investigators;
• Normal ECG recording on a 12-lead ECG at the screening visit:
• e. 120 ≤ PR \< 210 ms, f. QRS \< 120 ms, g. QTcf ≤ 450 ms, h. No sign of any trouble of sinusal automatism, i. Or considered NCS by investigators;
• Laboratory parameters within the normal range of the laboratory (hematology, hemostasis and blood biochemistry tests, urinalysis). Individual values out of the normal range can be accepted if judged clinically non-relevant by the Investigator, however serum creatinine, alkaline phosphatase, hepatic enzymes (aspartate aminotransferase, alanine aminotransferase), and total bilirubin (unless the subject has documented Gilbert syndrome) should not exceed the upper laboratory norm (isolated bilirubin up to 1.5 is accepted );
• Normal dietary habits;
• Normal nasal examination (including rhinoscopy) at Screening and Day-1;

You may not qualify if:

• Any relevant history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, infectious disease, endocrine, immunologic, dermatologic or/and any relevant disease;
• Any current or recent (\< 2 month) active nasal disease e.g., acute, and chronic rhinosinusitis, allergic rhinitis, Epistaxis, intra nasal polyp(s), nasal septum with strong deviation, otolaryngology inflammation;
• Any treatment or other nasal administration \< 2 months;
• Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician;
• Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month);
• Symptomatic hypotension whatever the decrease of the blood pressure or asymptomatic postural hypotension defined by a decrease in SBP equal to or greater than 20 mmHg or DBP equal to or greater than 10 mmHg within two minutes of changing from supine to standing position;
• Positive urine drug testing (amphetamines, methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates) or alcohol testing at Screening or Day -1;
• Positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests;
• Clinical symptoms suspected of acute infectious disease within 2 weeks before the first study drug administration;
• History or presence of drug in particular per inhalation, or alcohol abuse (alcohol consumption \> 40 grams / day);
• Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day);
• Blood donation (including as part of a clinical trial) in the 2 months before the administration;
• General anesthesia in the 3 months before administration;
• Inability to abstain from intense muscular effort;
• No possibility of contact in case of emergency;

Sponsors & Collaborators

• Ceres Brain Therapeutics: lead
• Eurofins Optimed: collaborator

Study Sites (1)

Eurofins Optimed

Gières, 38610, France

Location

MeSH Terms

Conditions

Nervous System Diseases

Study Officials

• Thomas JOUDINAUD

  Ceres Brain Therapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: July 3, 2025
• Study Start: March 14, 2025
• Primary Completion: September 26, 2025
• Study Completion: September 26, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)