Healthy VolunteersPhase 1LEUCETTANCT06206824
Leucettinib-21 First-in-Human Phase 1 in Healthy Volunteers and Subjects With Down Syndrome and Alzheimer's Disease
A Phase 1 study testing Leucettinib-21 in people with Healthy Volunteers and Down Syndrome, run by Perha Pharmaceuticals at 1 site in France.
Trial summary
Leucettinib-21 First-in-Human Phase 1 Study in 6 Parts: Single (Part 1 and 5) and Multiple (Part 3 and 6) Ascending Doses, and Food-Effect (Part 2) in Healthy Subjects, and Single Dose (Part 4) in People with Down Syndrome (DS) and Alzheimer's Disease (AD). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Down Syndrome, Alzheimer's Disease
- What is being tested?
- Leucettinib-21
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jan 2024to 25 Jun 2026
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Part 5: Healthy male and female aged to 18-55 years inclusive / Part 6: Healthy male aged to 18-55 years inclusive
- Part 1, 2, 3, 5 \& 6 for males: 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 4 months after last IMP 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, true abstinence is acceptable when it is in line with the subject's preferred and usual lifestyle) / Part 5 for females of childbearing potential: Must agree to adhere to the contraception requirements: use for the subject of a highly effective method of birth control (defined as methods that can achieve a failure rate less than 1per 100 per year when used consistently and correctly) restricted to non-hormonal intra uterine device or non-hormonal intra uterine system, vasectomized partner and use of a second form of contraception. Hormonal methods of contraception whichever the mode of administration are not permitted. The following acceptable methods can be used as a second form of contraception during the study: partner's use of a condom or the subject's use of an occlusive cap [diaphragm or cervical/vault caps] with spermicidal foam, gel, film, cream, or suppository from the time of informed consent signature and for 4 months after the last study drug administration. True sexual abstinence when this is in line with the preferred and usual lifestyle of the subject is acceptable. Periodic abstinence (e.g., calendar ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of the trial and withdrawal are NOT acceptable methods of contraception / Part 5 for females of non-childbearing potential: female subjects who are postmenopausal (defined as spontaneous amenorrhea for at least 1 year or spontaneous amenorrhea for at least 6 months confirmed by follicle-stimulating hormone [FSH] result of ≥ 40 IU/mL) are eligible for this study and female subjects with surgical sterilization (i.e., bilateral tubal ligation/salpingectomy, hysterectomy) also;
- Non-smoker subject or smoker of not more than 5 cigarettes a day;
- Parts 1, 2, 3 \& 6: Body Mass Index (BMI) between 18.5 and 28,0 (kg/m2) inclusive, with body weight between 60 and 100 kg inclusive, at Screening and Day -1 / Part 5: Body Mass Index (BMI) between 18.5 and 28,0 (kg/m2) inclusive, with body weight between 50 and 100 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), oxygen saturation and Heart Rate (HR) at the screening visit after 10 minutes in supine position:
Show all 57Show fewer
- 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,
- QRS < 120 ms,
- QTcf ≤ 430 ms for male,
- No sign of any trouble of sinusal automatism,
- 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;
- Normal dietary habits;
- 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.
- Non-inclusion criteria for Parts 1, 2, 3, 5 \& 6:
- Any 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;
- Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician;
- 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 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;
- Any drug intake (except paracetamol) during the month prior to the first administration;
- History or presence of drug or alcohol abuse (alcohol consumption > 40 grams / day);
- Blood donation (including as part of a clinical trial) in the 2 months before administration;
- General anesthesia in the 3 months before administration;
- Inability to abstain from intense muscular effort;
- No possibility of contact in case of emergency;
- Excessive consumption of beverages with xanthine bases (>4cups or glasses/day);
- 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;
- Administrative or legal supervision;
- 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.
- Main inclusion criteria for Part 4:
- Down Syndrome and Alzheimer's disease male individuals;
- Must agree to adhere to the contraception requirements;
- Non-smoker subject or smoker of not more than 5 cigarettes a day;
- Patient and/or their legal representatives (if applicable) are able to understand and provide written informed consent before starting any study-related activity according investigator judgment;
- Patient is able to participate fully in the study, be sufficiently proficient in the official language of the country in which they live, and be able to carry out study evaluations reliably;
- Blood Pressure (BP), oxygen saturation and Heart Rate (HR) at the screening visit after 10 minutes in supine position considered normal according the population or judged clinically non-relevant by investigators;
- ECG recording on a 12-lead ECG at the screening visit considered normal according the population or judged clinically non-relevant 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 according the population;
- Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research;
- Presence of an accompanying caregiver at the end of the study.
- Main exclusion criteria for Part 4:
- Any relevant history or presence of significant diseases that would interfere with the assessment according the population except stabilized pathology with associated treatment for more than 3 months and known in the medical history;
- Patients considered unable to complete study assessments, according the investigator judgment;
- History of cancer in the past 5 years;
- History of inflammatory disease with potential for central nervous system involvement;
- Positive urine drug testing 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Evaluate Safety, Tolerability, PK/PD of SAD, MAD and Food Effect of Leucettinib-21 in Healthy Male Subjects, and Single Dose in Subjects With Down Syndrome or Alzheimer's Disease
Leucettinib-21 First-in-Human Phase 1 Study in 6 Parts: Single (Part 1 and 5) and Multiple (Part 3 and 6) Ascending Doses, and Food-Effect (Part 2) in Healthy Subjects, and Single Dose (Part 4) in People with Down Syndrome (DS) and Alzheimer's Disease (AD).
For Parts 1, 3, 4, 5 and 6, safety and tolerability of an oral administration of Leucettinib-21 will be assessed as primary objectives. Pharmacokinetics and pharmacodynamic biomarkers will be investigated as secondary objectives.
For Part 2, the effect of high fat meal will be evaluated on the pharmacokinetics parameters after an oral administration of Leucettinib-21.
- Conditions
- Healthy Volunteers, Down Syndrome, Alzheimer's Disease
- Being tested
- Leucettinib-21
- Medical subject headings
- Down Syndrome, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leucettinib-21Drug
See arm's description.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 : Single Ascending Doses in Healthy Volunteers | Experimental | A total of 48 healthy male volunteers will be randomized into six consecutive single ascending dose cohorts of 8 subjects, 6 receiving one dose of Leucettinib-21 and 2 receiving placebo. Receives: Drug: Leucettinib-21 |
| Part 2 : Food-Effect in Healthy Volunteers | Experimental | A total of 12 healthy male volunteers will be randomly assigned to one of two sequences in this cross over study part. All subjects will receive the same one dose of Leucettinib-21 in each sequence. Receives: Drug: Leucettinib-21 |
| Part 3 : Multiple Ascending Doses over 14 days in Healthy Volunteers | Experimental | A total of 36 healthy male volunteers will be randomized into three consecutive multiple ascending doses cohorts of 12 subjects, 9 receiving one dose of Leucettinib-21 and 3 receiving placebo everyday for 14 days. Receives: Drug: Leucettinib-21 |
| Part 4 : Single Dose in People with Down Syndrome and Alzheimer's Disease | Experimental | A total of 12 people with Down Syndrome and 12 people with Alzheimer's Disease will receive the same one dose of Leucettinib-21. Receives: Drug: Leucettinib-21 |
| Part 5 : Single Ascending Doses in Healthy Volunteers | Experimental | A total of 24 healthy volunteers will be randomized into two consecutive single ascending dose cohorts, of 16 male and female subjects for the first cohort, 12 receiving one dose of Leucettinib-21 and 4 receiving placebo, and 8 male subjects for the following cohorts, 6 receiving one dose of Leucettinib-21 and 2 receiving placebo. Receives: Drug: Leucettinib-21 |
| Part 6 : Single dose over 14 days in Healthy Volunteers | Experimental | A total of 12 healthy male volunteers will be randomized into one cohort of 12 subjects, 9 receiving one dose of Leucettinib-21 and 3 receiving placebo everyday for 14 days. Receives: Drug: Leucettinib-21 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 : Safety and tolerability of Leucettinib-21 after single administration at 6 increasing doses in healthy male subjects.
Assessment of systemic tolerability and safety
Measured: Part 1 : Up to 8 days following administration
Part 2 : Effect of food on the PK parameters after an oral administration of Leucettinib-21 in healthy male subjects in high fat breakfast condition vs. under fasted conditions.
Plasma PK assessments
Measured: Part 2 : Up to 8 days following administration
Part 3 : Safety and tolerability of Leucettinib-21 after multiple administration at 3 increasing doses in healthy male subjects
Assessment of systemic tolerability and safety
Measured: Part 3 : Up to 21 days following administration
Part 4 : Safety and tolerability of Leucettinib-21 after single administration at 1 dose in Down Syndrome individuals and patients with Alzheimer's disease
Assessment of systemic tolerability and safety
Measured: Part 4 : Up to 8 days following administration
Part 5 : Number of participants with treatment-related adverse events after single administration of Leucettinib-21 at 2 increasing doses in healthy male and female subjects.
Assessment of systemic tolerability and safety:
- Adverse Events
- Vital signs
- Physical examination
- ECG
- Biological tests
Measured: Part 5 : Up to 8 days following administration
Part 6 : Number of participants with treatment-related adverse events after repeated administration of Leucettinib-21 at 1 dose for 14 days in healthy male subjects
Assessment of systemic tolerability and safety:
- Adverse Events
- Vital signs
- Physical examination
- ECG
- Biological tests
- Psychometric tests (REST-SPER / FOCU SHIF)
- Insulin, glucagon and somatostatin dosage
- NT-pro BNP and troponin
Measured: Part 6 : Up to 21 days following administration
Secondary outcomes (3)
PK of Leucettinib-21
Assessment of the plasmatic PK of Leucettinib-21
Measured: Up to 24 hours following Leucettinib-21 administration
PD of Leucettinib-21
Change in the proteome following Leucettinib-21 administration assessed by phosphoproteomics
Measured: Up to 24 hours following Leucettinib-21 administration
Activity of DYRK1A
Change in DYRK1A activity following Leucettinib-21 administration assessed in Peripheral Blood Mononuclear Cells
Measured: Up to 8 hours following Leucettinib-21 administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start18 Jan 2024
- Primary completion25 Jun 2026
- Study completion25 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perha Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- France 2030 program, European Innovation Council, Fondation Jérôme Lejeune
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206824
- Sponsor's protocol ID
- OP112522
- Other IDs
- 2023-507075-22, 2023
- Acronym
- LEUCETTA
- Status last verified
- Jun 2026
- First submitted
- 20 Dec 2023
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Evaluate Safety, Tolerability, PK/PD of SAD, MAD and Food Effect of Leucettinib-21 in Healthy Male Subjects, and Single Dose in Subjects With Down Syndrome or Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06206824
- Acronym / sponsor ID
- LEUCETTA / OP112522
- Conditions
- Healthy Volunteers, Down Syndrome, Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Perha PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- France 2030 program, European Innovation Council, Fondation Jérôme Lejeune
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 25 Jun 2026 (actual)
- Study completion
- 25 Jun 2026 (actual)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Leucettinib-21 First-in-Human Phase 1 Study in 6 Parts: Single (Part 1 and 5) and Multiple (Part 3 and 6) Ascending Doses, and Food-Effect (Part 2) in Healthy Subjects, and Single Dose (Part 4) in People with Down Syndrome (DS) and Alzheimer's Disease (AD).
For Parts 1, 3, 4, 5 and 6, safety and tolerability of an oral administration of Leucettinib-21 will be assessed as primary objectives. Pharmacokinetics and pharmacodynamic biomarkers will be investigated as secondary objectives.
For Part 2, the effect of high fat meal will be evaluated on the pharmacokinetics parameters after an oral administration of Leucettinib-21.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1 : Single Ascending Doses in Healthy Volunteers | Experimental | Drug: Leucettinib-21A total of 48 healthy male volunteers will be randomized into six consecutive single ascending dose cohorts of 8 subjects, 6 receiving one dose of Leucettinib-21 and 2 receiving placebo. |
| Part 2 : Food-Effect in Healthy Volunteers | Experimental | Drug: Leucettinib-21A total of 12 healthy male volunteers will be randomly assigned to one of two sequences in this cross over study part. All subjects will receive the same one dose of Leucettinib-21 in each sequence. |
| Part 3 : Multiple Ascending Doses over 14 days in Healthy Volunteers | Experimental | Drug: Leucettinib-21A total of 36 healthy male volunteers will be randomized into three consecutive multiple ascending doses cohorts of 12 subjects, 9 receiving one dose of Leucettinib-21 and 3 receiving placebo everyday for 14 days. |
| Part 4 : Single Dose in People with Down Syndrome and Alzheimer's Disease | Experimental | Drug: Leucettinib-21A total of 12 people with Down Syndrome and 12 people with Alzheimer's Disease will receive the same one dose of Leucettinib-21. |
| Part 5 : Single Ascending Doses in Healthy Volunteers | Experimental | Drug: Leucettinib-21A total of 24 healthy volunteers will be randomized into two consecutive single ascending dose cohorts, of 16 male and female subjects for the first cohort, 12 receiving one dose of Leucettinib-21 and 4 receiving placebo, and 8 male subjects for the following cohorts, 6 receiving one dose of Leucettinib-21 and 2 receiving placebo. |
| Part 6 : Single dose over 14 days in Healthy Volunteers | Experimental | Drug: Leucettinib-21A total of 12 healthy male volunteers will be randomized into one cohort of 12 subjects, 9 receiving one dose of Leucettinib-21 and 3 receiving placebo everyday for 14 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (57 listed)
- Part 5: Healthy male and female aged to 18-55 years inclusive / Part 6: Healthy male aged to 18-55 years inclusive
- Part 1, 2, 3, 5 \& 6 for males: 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 4 months after last IMP 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, true abstinence is acceptable when it is in line with the subject's preferred and usual lifestyle) / Part 5 for females of childbearing potential: Must agree to adhere to the contraception requirements: use for the subject of a highly effective method of birth control (defined as methods that can achieve a failure rate less than 1per 100 per year when used consistently and correctly) restricted to non-hormonal intra uterine device or non-hormonal intra uterine system, vasectomized partner and use of a second form of contraception. Hormonal methods of contraception whichever the mode of administration are not permitted. The following acceptable methods can be used as a second form of contraception during the study: partner's use of a condom or the subject's use of an occlusive cap [diaphragm or cervical/vault caps] with spermicidal foam, gel, film, cream, or suppository from the time of informed consent signature and for 4 months after the last study drug administration. True sexual abstinence when this is in line with the preferred and usual lifestyle of the subject is acceptable. Periodic abstinence (e.g., calendar ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of the trial and withdrawal are NOT acceptable methods of contraception / Part 5 for females of non-childbearing potential: female subjects who are postmenopausal (defined as spontaneous amenorrhea for at least 1 year or spontaneous amenorrhea for at least 6 months confirmed by follicle-stimulating hormone [FSH] result of ≥ 40 IU/mL) are eligible for this study and female subjects with surgical sterilization (i.e., bilateral tubal ligation/salpingectomy, hysterectomy) also;
- Non-smoker subject or smoker of not more than 5 cigarettes a day;
- Parts 1, 2, 3 \& 6: Body Mass Index (BMI) between 18.5 and 28,0 (kg/m2) inclusive, with body weight between 60 and 100 kg inclusive, at Screening and Day -1 / Part 5: Body Mass Index (BMI) between 18.5 and 28,0 (kg/m2) inclusive, with body weight between 50 and 100 kg inclusive, at Screening and Day -1;
- Considered as healthy after a comprehensive clinical assessment (detailed medical history and complete physical examination);
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leucettinib-21See arm's description. | Drug | Part 1 : Single Ascending Doses in Healthy Volunteers, Part 2 : Food-Effect in Healthy Volunteers, Part 3 : Multiple Ascending Doses over 14 days in Healthy Volunteers, Part 4 : Single Dose in People with Down Syndrome and Alzheimer's Disease, Part 5 : Single Ascending Doses in Healthy Volunteers, Part 6 : Single dose over 14 days in Healthy Volunteers |
Primary outcome
Part 1 : Safety and tolerability of Leucettinib-21 after single administration at 6 increasing doses in healthy male subjects.
Time frame: Part 1 : Up to 8 days following administration
Assessment of systemic tolerability and safety
Part 2 : Effect of food on the PK parameters after an oral administration of Leucettinib-21 in healthy male subjects in high fat breakfast condition vs. under fasted conditions.
Time frame: Part 2 : Up to 8 days following administration
Plasma PK assessments
Part 3 : Safety and tolerability of Leucettinib-21 after multiple administration at 3 increasing doses in healthy male subjects
Time frame: Part 3 : Up to 21 days following administration
Assessment of systemic tolerability and safety
Part 4 : Safety and tolerability of Leucettinib-21 after single administration at 1 dose in Down Syndrome individuals and patients with Alzheimer's disease
Time frame: Part 4 : Up to 8 days following administration
Assessment of systemic tolerability and safety
Part 5 : Number of participants with treatment-related adverse events after single administration of Leucettinib-21 at 2 increasing doses in healthy male and female subjects.
Time frame: Part 5 : Up to 8 days following administration
Assessment of systemic tolerability and safety: * Adverse Events * Vital signs * Physical examination * ECG * Biological tests
Part 6 : Number of participants with treatment-related adverse events after repeated administration of Leucettinib-21 at 1 dose for 14 days in healthy male subjects
Time frame: Part 6 : Up to 21 days following administration
Assessment of systemic tolerability and safety: * Adverse Events * Vital signs * Physical examination * ECG * Biological tests * Psychometric tests (REST-SPER / FOCU SHIF) * Insulin, glucagon and somatostatin dosage * NT-pro BNP and troponin
3 secondary outcomes
PK of Leucettinib-21
Time frame: Up to 24 hours following Leucettinib-21 administration
PD of Leucettinib-21
Time frame: Up to 24 hours following Leucettinib-21 administration
Activity of DYRK1A
Time frame: Up to 8 hours following Leucettinib-21 administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Leucettinib-21 in people with Healthy Volunteers and Down Syndrome, run by Perha Pharmaceuticals 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 57 inclusion and 0 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 30 Jun 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. 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 of Leucettinib-21 after single administration at 6 increasing doses in healthy male subjects. (time frame: Part 1 : Up to 8 days following administration). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2026.