Actively Recruiting
Leucettinib-21 First-in-Human Phase 1 in Healthy Volunteers and Subjects With Down Syndrome and Alzheimer's Disease
Led by Perha Pharmaceuticals · Updated on 2025-12-10
164
Participants Needed
1
Research Sites
123 weeks
Total Duration
On this page
Sponsors
P
Perha Pharmaceuticals
Lead Sponsor
F
France 2030 program
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Leucettinib-21 First-in-Human Phase 1 in Healthy Volunteers and Subjects With Down Syndrome and Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy males aged 18 to 55 years for Parts 1, 2, 3, 5 and 6
- Healthy females aged 18 to 55 years for Part 5
- Males must agree to use effective contraception from consent until 4 months after last drug dose for Parts 1, 2, 3, 5 and 6
- Females of childbearing potential in Part 5 must use non-hormonal intrauterine devices and a second form of contraception
- Females who are postmenopausal or surgically sterilized are eligible for Part 5
- Non-smokers or smokers of no more than 5 cigarettes per day
- BMI between 18.5 and 28.0 kg/m2 and weight 60-100 kg for Parts 1, 2, 3 and 6; 50-100 kg for Part 5
- Considered healthy after clinical assessment
- Normal blood pressure, oxygen saturation, and heart rate at screening
- Normal ECG at screening or deemed normal by investigators
- Laboratory values within normal range or clinically non-relevant
- Normal dietary habits
- Signed informed consent
- Covered by health insurance and compliant with national biomedical research laws
- For Part 4: males with Down Syndrome or Alzheimer's disease
- Able to provide informed consent or legal representative consent for Part 4
- Able to participate fully and communicate reliably in official language
- Normal or clinically non-relevant blood pressure, oxygen saturation, heart rate and ECG at screening for Part 4
- Laboratory values within normal range or clinically non-relevant for Part 4
- Covered by health insurance
- Presence of caregiver at study end for Part 4
You will not qualify if you...
- History or presence of cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, psychiatric, systemic, infectious, endocrine, immunologic, or dermatologic disease
- Drug hypersensitivity or allergic diseases requiring treatment
- Symptomatic or significant postural hypotension
- Positive urine drug or alcohol test at screening
- Positive tests for Hepatitis B, Hepatitis C, or HIV
- Symptoms of acute infection within 2 weeks before dosing
- Use of any drugs except paracetamol within 1 month before dosing
- History of drug or alcohol abuse (alcohol >40 grams/day)
- Blood donation within 2 months before dosing
- General anesthesia within 3 months before dosing
- Inability to abstain from intense muscular effort
- No emergency contact possibility
- Excessive caffeine or xanthine consumption (>4 cups/day)
- Likely to be non-compliant or uncooperative
- Legal or administrative restrictions (e.g., judicial decision, guardianship)
- Participation in another study within 4 weeks or 5 half-lives of last experimental drug
- Receiving over 6000 euros in biomedical research indemnities in past 12 months
- For Part 4: any significant disease interfering with assessment unless stabilized >3 months
- Inability to complete study assessments for Part 4
- Cancer history in past 5 years for Part 4
- Inflammatory diseases with CNS involvement for Part 4
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Eurofins Optimed
Gières, France, 38610
Actively Recruiting
Research Team
L
Laurent MEIJER, Dr
CONTACT
E
Emilie CHRETIEN, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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