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A Phase 1 (First in Human) Randomized, Double-blind, Placebo-controlled SAD, MAD Study With Oral REM0046127
A Phase 1 (First in Human) Randomized, Double-blind, Placebo-controlled SAD, MAD Study With an Adaptive Dose Design to Evaluate the Safety, Tolerability, and Pharmacokinetics of REM0046127 in Healthy Subjects
Lead sponsor
Asset
REM0046127
Listed sites
1
Recruiting sites
-
Enrollment
77
actual
Study population
Alzheimer’s disease
Key I/E criterion
•Age 18-80
Primary endpoints
•Adverse Events•SAD•MAD
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. SAD/MAD: Young male subjects aged 18 to 45 years (limits included) willing and able to give their written consent to participate in the trial after having received information about the study design, the objectives of the project, the possible derivative risks, and their right to withdraw from the study at any time and for any reason
2. Elderly Cohorts: Elderly male and female (not of childbearing potential) subjects aged 55 to 80 (limits included) willing and able to give their written consent to participate in the trial after having received information about the study design, the objectives of the project, the possible derivative risks, and their right to withdraw from the study at any time and for any reason.
3. Women not of childbearing potential: Clinically significant abnormalities in screening laboratory tests, including:
4. Electrocardiogram without clinically significant pathologic abnormalities and with corrected QT interval (cQT) values lesser than 450 ms
5. Normotensive as defined by Systolic Blood Pressure ≤ 150 mm Hg. Diastolic Blood Pressure ≤ 90 mm Hg without antihypertensive medication
6. Body Mass Index (BMI) between 18 and 30 kg/m2.
7. Body weight between 60 and 80 kg, inclusive
Only for the elderly cohort of the MAD:
8. Participants may be taking medication for non-serious chronic diseases, provided that the dose of these concomitant medications has been stable within the previous 2 months
9. No suicidal ideation, as demonstrated by a score of "0" on the Columbia Suicide Severity Rating Scale (C-SSRS)
Exclusion criteria
1. Women of childbearing potential (WOCBP)
2. Failure to perform screening or baseline examinations
3. Any chronic medical condition (such as type 1 diabetes) requiring chronic treatment that might increase the risk to the subject or confound the interpretation of safety observations according to the clinical assessment of the investigator (physician)
4. Evidence of active infection requiring antibiotic therapy within 14 days prior to screening
5. Medical history of vasculitis or any autoimmune disease excluding seasonal allergic rhinitis and childhood history of atopic dermatitis
6. History of any treatment for cancer within the past 2 years, other than basal cell or squamous cell carcinoma of the skin
7. Seropositive for human immunodeficiency virus (HIV)
8. History of acute/chronic hepatitis B or C and/or carriers of hepatitis B (seropositive for Hepatitis B surface antigen [HbsAg] or anti-Hepatitis C [Hepatitis C Virus (HCV)] antibody)
9. Clinically significant abnormalities in screening laboratory tests, including:
10. Use of an investigational drug within 2 months prior to dosing in this study
11. Any disorder that could interfere with the absorption, distribution, metabolism or excretion of drugs (e.g. small bowel disease, Crohn's disease, celiac disease, or liver disease)
12. Chronic kidney disease (defined as the presence of any degree of proteinuria on urine analysis and/or an eGFR of <60 ml/min using the (Modification of Diet in Renal Disease (MDRD) formula)
13. Psychiatric history of current or past psychosis, bi-polar disorder, major depression, or anxiety disorder requiring chronic medication within the past 5 years
14. History of substance abuse, including alcohol and nicotine or positive urine drug screen at screening visit
15. Any reason or opinion of the investigator that would prevent the subject from participation in the study
16. Inability to follow the instructions or an unwillingness to collaborate during the study
17. Male subjects with female partner of child-bearing potential who are unwilling or unable to adhere to contraception requirements
Only for the elderly cohort of the MAD:
18. Chronic daily drug intake during the study period:
19. History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years
20. Clinically significant, advanced or unstable disease that may interfere with primary or secondary variable evaluations, and which may bias the assessment of the clinical or mental status of the volunteer or put the volunteer at special risk, such as:
Endpoints (8)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Fluid / digital biomarkers
1 endpointCerebrospinal Fluid (CSF) PK (MAD)
Time frame:CSF samples will be collected on the last day of dosing (Day 7) at approximately Tmax determined during SAD
descriptive
Safety / tolerability / PK
7 endpointsAdverse Events
Time frame:SAD: from dosing to 72 hours after dosing. MAD: from the first dosing until 48 hours after the last dosing on day 7.
event count, event
SAD: Plasma Concentration including Peak Plasma Concentration (Cmax)
Time frame:Plasma samples will be taken during SAD at baseline and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose.
concentration, descriptive
SAD: Plasma Concentration including Half-Life(t1/2)
Time frame:Plasma samples will be taken during SAD at baseline and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose.
concentration, descriptive
SAD: Area under the Curve (AUC)
Time frame:Plasma samples will be taken during SAD at baseline and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose.
concentration, descriptive
MAD: Half-Life(t1/2) between Baseline and 48 hours after the last dosing.
Time frame:Plasma samples will be taken pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours post-dose, pre-dose on Day 5 and on Day 7: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours (Day 8) and 48 hours (Day 9).
concentration, descriptive
MAD: Plasma Concentration
Time frame:Plasma samples will be taken pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours post-dose, pre-dose on Day 5 and on Day 7: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours (Day 8) and 48 hours (Day 9).
concentration, descriptive
MAD: Area under the Curve (AUC)
Time frame:Plasma samples will be taken pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours post-dose, pre-dose on Day 5 and on Day 7: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours (Day 8) and 48 hours (Day 9).
concentration, descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.