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Neurologic Diseases, GeneralPhase 1CBT101NCT07050316

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

A Phase 1 study testing CBT101 in people with Neurologic Diseases, General, run by Ceres Brain Therapeutics at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Neurologic Diseases, General
What is being tested?
CBT101
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteFrance
Study dates
14 Mar 2025to 26 Sep 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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:
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  • 95 mmHg ≤ Systolic Blood Pressure (SBP) ≤ 140 mmHg,
  • 50 mmHg ≤ Diastolic Blood Pressure (DBP) ≤ 90 mmHg,
  • 45 bpm ≤ HR ≤ 90 bpm,
  • Or considered NCS by investigators;
  • Normal ECG recording on a 12-lead ECG at the screening visit:
  • 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;
  • Signing a written informed consent prior to selection;
  • Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.

Who cannot join

  • 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);
  • Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life of the medication; any vaccination within the last 28 days;
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  • Any food supplement containing creatine within the last 14 days before inclusion;
  • 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;
  • Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development;
  • Persons deprived of their liberty by judicial or administrative decision; persons under coercive psychiatric care; adults under legal protection (guardianship/trusteeship); persons under court protection;
  • Subject in the exclusion period of a previous study and within less than 4 weeks or 5 half-lives of the last administration of an experimental drug;
  • Subject who would receive more than 6000 euros as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Eurofins Optimed

    Gières, 38610

Other trials in France

About this study

Official title: 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

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.

Read the detailed description

The product developed by Ceres-Brain Therapeutics is a creatine-based drug called CBT101.

CBT101 is a product designed to deliver creatine to brain cells. CBT101 will be administered into the nasal cavity via a nasal spray, enabling the product to reach the brain, and neurons in particular, rapidly. In the neurons, CBT101 will be converted into creatine.

This product is indicated for adults and children suffering from creatine deficiency syndrome, or for neurological diseases where a supply of energy, in the form of creatine, would be useful. These include Creatine Transporter Deficiency (a rare genetic disease that affects children and manifests itself in autistic disorders, intellectual deficits, major communication and developmental disorders, particularly psychomotor disorders, and epileptic seizures) and Charcot's disease (a degenerative disease of neurons that unfortunately currently has no curative treatment).This study is divided into 2 parts and will include a total of 48 healthy male volunteers aged between 18 and 55.

The primary objective is to evaluate the safety and tolerability of CBT101 after 14 days of repeated intranasal dosing at 3 ascending doses.

The secondary objective is to determine the pharmacokinetic parameters (study of the fate of the drug in the body) of CBT101 or its metabolites. The first part is a Single Ascending Doses (SAD) composed of 3 cohorts at the following doses: 4.2 mg, 8.4 mg and 12.6 mg. The second part is a Multiple Ascending Doses (MAD), comprising 3 cohorts at the following doses: 4.2 mg, 8.4 mg and 12.6 mg. There will be 8 participants per cohort, of whom 6 will receive CBT101 and 2 will receive placebo.

Being tested
CBT101, Placebo
Medical subject headings
Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBT101Drug

    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)

  • PlaceboDrug

    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)
Study groups in NCT07050316
Study groupRoleWhat they receive
PlaceboPlacebo comparatorSubjects 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.
Receives: Drug: Placebo
CBT101ExperimentalSubjects 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.
Receives: Drug: CBT101

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1 : Safety and tolerability assessment:

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

    Measured: From screening to the last visit (4weeks)

  2. Part 2 : Safety and tolerability assessment

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

    Measured: From screening to the last visit (6 weeks)

  3. Part 1 : Safety and tolerability assessment:

    Change in nasal examination, including anterior rhinoscopy over the study

    Measured: From screening to the last visit (4weeks)

  4. 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

    Measured: From screening to the last visit (4weeks)

  5. Part 1 : Safety and tolerability assessment:

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

    Measured: From screening to the last visit (4weeks)

  6. Part 1 : Safety and tolerability assessment:

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

    Measured: From screening to the last visit (4weeks)

  7. Part 1 : Safety and tolerability assessment:

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

    Measured: From screening to the last visit (4weeks)

  8. Part 2 : Safety and tolerability assessment

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

    Measured: From screening to the last visit (6 weeks)

  9. 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

    Measured: From screening to the last visit (6 weeks)

  10. Part 2 : Safety and tolerability assessment

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

    Measured: From screening to the last visit (6 weeks)

  11. Part 2 : Safety and tolerability assessment

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

    Measured: From screening to the last visit (6 weeks)

  12. Part 2 : Safety and tolerability assessment

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

    Measured: From screening to the last visit (6 weeks)

Secondary outcomes (24)

  1. Part 1 : Plasma pharmacokinetics assessment of CBT101

    • Cmax: Maximum observed plasma concentration

    Measured: From screening to the day 2 (3 weeks)

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

    • Cmax: Maximum observed plasma concentration;

    Measured: From screening to the day 2 (3 weeks)

  3. Part 1 : Plasma pharmacokinetics assessment of CBT101

    • Tmax: Time to maximum observed plasma concentration;

    Measured: From screening to the day 2 (3 weeks)

  4. Part 1 : Plasma pharmacokinetics assessment of CBT101

    • AUC0-t: Area under the concentration-time curve from baseline to last measurable concentration;

    Measured: From screening to the day 2 (3 weeks)

  5. Part 1 : Plasma pharmacokinetics assessment of CBT101

    • t1/2: Terminal elimination half-life;

    Measured: From screening to the day 2 (3 weeks)

  6. Part 1 : Plasma pharmacokinetics assessment of CBT101

    • CL: Clearance;

    Measured: From screening to the day 2 (3 weeks)

  7. Part 1 : Plasma pharmacokinetics assessment of CBT101

    • Vd: Apparent volume of distribution in the terminal phase;

    Measured: From screening to the day 2 (3 weeks)

  8. Part 1 : Plasma pharmacokinetics assessment of CBT101

    • AUC0-∞: Area under the plasma concentration-time Curve with extrapolation to infinity

    Measured: From screening to the day 2 (3 weeks)

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

    • Tmax: Time to maximum observed plasma concentration;

    Measured: From screening to the day 2 (3 weeks)

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

    • AUC0-t: Area under the concentration-time curve from baseline to last

    Measured: From screening to the day 2 (3 weeks)

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

    • t1/2: Terminal elimination half-life;

    Measured: From screening to the day 2 (3 weeks)

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

    • AUC0-∞: Area under the plasma concentration-time Curve with extrapolation to infinity.

    Measured: From screening to the day 2 (3 weeks)

  13. Part 2 : Plasma pharmacokinetics assessment of CBT101

    • Cmax: Maximum observed plasma concentration;

    Measured: From screening to the day 15 (5 weeks)

  14. Part 2 : Plasma pharmacokinetics assessment of CBT101

    • Tmax: Time to maximum observed plasma concentration;

    Measured: From screening to the day 15 (5 weeks)

  15. Part 2 : Plasma pharmacokinetics assessment of CBT101

    • AUC0-t: Area under the concentration-time curve from baseline to last

    Measured: From screening to the day 15 (5 weeks)

  16. Part 2 : Plasma pharmacokinetics assessment of CBT101

    • t1/2: Terminal elimination half-life;

    Measured: From screening to the day 15 (5 weeks)

  17. Part 2 : Plasma pharmacokinetics assessment of CBT101

    • CL: Clearance;

    Measured: From screening to the day 15 (5 weeks)

  18. Part 2 : Plasma pharmacokinetics assessment of CBT101

    • Vd: Apparent volume of distribution in the terminal phase;

    Measured: From screening to the day 15 (5 weeks)

  19. Part 2 : Plasma pharmacokinetics assessment of CBT101

    • AUC0-∞: Area under the plasma concentration-time Curve with extrapolation to infinity.

    Measured: From screening to the day 15 (5 weeks)

  20. Part 2 : The metabolites 1-dodecanol will be determined and several PK parameters will be calculated.

    • Cmax: Maximum observed plasma concentration;

    Measured: From screening to the day 15 (5 weeks)

  21. Part 2 : The metabolites 1-dodecanol will be determined and several PK parameters will be calculated.

    • Tmax: Time to maximum observed plasma concentration;

    Measured: From screening to the day 15 (5 weeks)

  22. Part 2 : The metabolites 1-dodecanol will be determined and several PK parameters will be calculated.

    • AUC0-t: Area under the concentration-time curve from baseline to last measurable concentration;

    Measured: From screening to the day 15 (5 weeks)

  23. Part 2 : The metabolites 1-dodecanol will be determined and several PK parameters will be calculated.

    • t1/2: Terminal elimination half-life;

    Measured: From screening to the day 15 (5 weeks)

  24. Part 2 : The metabolites 1-dodecanol will be determined and several PK parameters will be calculated.

    • AUC0-∞: Area under the plasma concentration-time Curve with extrapolation to infinity.

    Measured: From screening to the day 15 (5 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2025
  2. Study start14 Mar 2025
  3. Primary completion26 Sep 2025
  4. Study completion26 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07050316
Sponsor's protocol ID
CBT101 / OP112923.CER
Other IDs
2024-515549-40-00
Acronym
CBT101
Status last verified
Mar 2026
First submitted
30 Apr 2025
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CBT101 in people with Neurologic Diseases, General, run by Ceres Brain Therapeutics at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1 : Safety and tolerability assessment: (time frame: From screening to the last visit (4weeks)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07050316.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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