A Study to Investigate Safety, Tolerability and Pharmacokinetics of REM0045392 Compared With Placebo in Healthy Participants.

NCT07016464 | Terminated Phase 1

• 1 other identifier: REMAD-04
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This study is testing if the medicine REM0045392 is safe and well-tolerated. It also looks at whether food affects how the medicine works. The medicine will be tested in Healthy men (Part 1 and 2) and Healthy Older men and women (Part 3). Participants will take the medicine once (in Part 1) or during 14 days (in Part 2 and 3), with increasing doses. REM0045392 is being developed as a treatment for Alzheimer's disease.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment Related Adverse Events

  To assess the safety and tolerability of REM0045392

  Throughout the study, until 7-10 days post last dose

Secondary Outcomes (10)

• Assessment of pharmacokinetics (PK) in blood following single and multiple ascending oral dose administration

  Up to 48 hours after last intervention

• Assessment of pharmacokinetics (PK) in blood following single and multiple ascending oral dose administration

  Up to 48 hours after last intervention

• Assessment of pharmacokinetics (PK) in blood following single and multiple ascending oral dose administration

  Up to 48 hours after last intervention

• Assessment of pharmacokinetics (PK) in blood following single and multiple ascending oral dose administration

  Up to 48 hours after last intervention

• Assessment of pharmacokinetics (PK) in blood following single and multiple ascending oral dose administration

  Up to 48 hours after last intervention

Study Arms (14)

Part 1 SAD - Panel A Treatment Period 1

EXPERIMENTAL

Drug: REM0045392; Drug: Placebo

Part 1 SAD - Panel B Treatment Period 1

EXPERIMENTAL

Drug: REM0045392; Drug: Placebo

Part 1 SAD - Panel A Treatment Period 2

EXPERIMENTAL

Drug: REM0045392; Drug: Placebo

Part 1 SAD - Panel B Treatment Period 2

EXPERIMENTAL

Drug: REM0045392; Drug: Placebo

Part 1 SAD - Panel A Treatment Period 3

EXPERIMENTAL

Drug: REM0045392; Drug: Placebo

Part 1 SAD - Panel B Treatment Period 3

EXPERIMENTAL

Drug: REM0045392; Drug: Placebo

Part 1 SAD - Panel A Treatment Period 4

EXPERIMENTAL

Drug: REM0045392; Drug: Placebo

Part 1 SAD - Panel B Treatment Period 4

EXPERIMENTAL

Drug: REM0045392; Drug: Placebo

Part 2 MAD - Panel C

EXPERIMENTAL

Drug: REM0045392; Drug: Placebo

Part 2 MAD - Panel D

EXPERIMENTAL

Drug: REM0045392; Drug: Placebo

Part 2 MAD - Panel E

EXPERIMENTAL

Drug: REM0045392; Drug: Placebo

Part 3 Elderly - Panel G

EXPERIMENTAL

Drug: REM0045392; Drug: Placebo

Part 2 MAD - Panel F (optional)

EXPERIMENTAL

Drug: REM0045392; Drug: Placebo

Part 3 Elderly - Panel H (optional)

EXPERIMENTAL

Drug: REM0045392; Drug: Placebo

Interventions

REM0045392 DRUG

Liquid formulation

Part 1 SAD - Panel A Treatment Period 1; Part 1 SAD - Panel A Treatment Period 2; Part 1 SAD - Panel A Treatment Period 3; Part 1 SAD - Panel A Treatment Period 4; Part 1 SAD - Panel B Treatment Period 1; Part 1 SAD - Panel B Treatment Period 2; Part 1 SAD - Panel B Treatment Period 3; Part 1 SAD - Panel B Treatment Period 4; Part 2 MAD - Panel C; Part 2 MAD - Panel D; Part 2 MAD - Panel E; Part 2 MAD - Panel F (optional); Part 3 Elderly - Panel G; Part 3 Elderly - Panel H (optional)

Placebo DRUG

Liquid formulation

Part 1 SAD - Panel A Treatment Period 1; Part 1 SAD - Panel A Treatment Period 2; Part 1 SAD - Panel A Treatment Period 3; Part 1 SAD - Panel A Treatment Period 4; Part 1 SAD - Panel B Treatment Period 1; Part 1 SAD - Panel B Treatment Period 2; Part 1 SAD - Panel B Treatment Period 3; Part 1 SAD - Panel B Treatment Period 4; Part 2 MAD - Panel C; Part 2 MAD - Panel D; Part 2 MAD - Panel E; Part 2 MAD - Panel F (optional); Part 3 Elderly - Panel G; Part 3 Elderly - Panel H (optional)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male participants between 18 and 55 years of age, inclusive, at screening. For Part 3: male and females participants, aged between 65 and 85 years of age, inclusive, at screening
• Otherwise healthy with no clinically significant abnormalities as determined by medical history, coagulation, blood chemistry assessments, hematologic assessments, and urinalysis at screening; and physical examination, measurement of vital signs and ECG at screening and Day 1 predose (of the first treatment period, if applicable).
• Note: Isolated out-of-range values judged by the investigator (or designated physician) to be of no clinical significance can be allowed. This determination must be recorded in the electronic source (eSource) system.
• For Part 3: elderly participants should be healthy for age. Mild and controlled comorbidities can be allowed at the discretion of the Investigator - as long as they do not interfere with the objectives of the study
• Have a body weight in the range of 50 to 100 kg, inclusive, at screening. Have a body mass index (BMI) of 19.0 to 30.0 kg/m2, inclusive, at screening.
• For Part 3: have a BMI of 19.0 to 32.0 kg/m2, inclusive, at screening
• Agree to abstain from alcohol intake 24 hours before administration of investigational product, during the in-patient period of the study, and 24 hours prior to all other out patient clinic visits.
• Agree not to use prescription medications within 14 days prior to first investigational product administration and through the end of the study, unless approved by the investigator.
• For Part 3: elderly participants can be allowed to take their chronic medication (\> 3 months stable dose) if this medication does not interfere with the absorption, distribution and elimination of the study drug.
• Agree not to use over-the-counter medications (including corticosteroids, Aspirin, decongestants, antihistamines, and other non-steroidal anti-inflammatory drugs \[NSAIDs\]), and herbal medication (including herbal tea, St. John's Wort), within 14 days prior to the first investigational product administration through the end of the study, unless approved by the investigator.
• Have signed the Informed Consent Form (ICF) voluntarily before any study related procedure is performed, indicating that the participant understands the purpose of, and procedures required for the study and is willing to participate in the study.
• Male participants who are sexually active with a female partner must agree to the use of an effective method of birth control throughout the study and until 90 days after the last administration of investigational product. Sperm donation is also not allowed from the first administration until 90 days after the last administration of investigational product.
• Note: Medically acceptable method of contraception that may be used by the participant includes vasectomy for male participants and for non-vasectomized male participants having a female partner of childbearing potential acceptable options includes using a condom in combination with one of the following: combined oral contraceptive, contraceptive injection, intrauterine device, levonorgestrel implant, or being surgically sterile. For male participants having a female pregnant partner, a condom must be used.
• For Part 3: female participants should be postmenopausal as defined as spontaneous amenorrhea for more then 12 consecutive months; or spontaneous amenorrhea for less then 6 months with biochemical criteria of menopause (follicle-stimulating hormone \>40 IU/L) or surgically sterile.

You may not qualify if:

• Currently have or have a history of any clinically significant medical illness or medical disorders the investigator considers should exclude the participant, including (but not limited to) cardiovascular disease, neuromuscular disease, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, diseases affecting bone mineral density, endocrine disease, or dermatological disease.
• Have a clinically significant or chronic infection or diagnosed latent infection.
• Significant acute illness within 7 days prior to the first investigational product administration or have had a major illness or hospitalization within 1 month prior to the first investigational product administration.
• For CSF collection:
• Lower back surgery in the past interfering with lumbar puncture
• History of severe Post Dural Puncture Headache requiring blood patch (PDPH)
• History or indications of elevated intracranial pressure as observed (fundoscopy)
• Any of the following findings on resting ECG:
• QT interval corrected for heart rate (HR) using Fridericia's formula (QTcF) \> 450 ms (males) or \< 300 ms at screening or baseline visit (Day 1 pre dose).
• Notable resting bradycardia (HR \< 40 bpm) or tachycardia (HR \> 100 bpm) at screening or baseline visit (Day 1 pre-dose).
• Family history of congenital long QT syndrome or sudden death.
• Screening or baseline (Day 1 pre-dose) ECG with QRS and/or T wave judged to be unfavorable for a consistently accurate QT measurement (e.g., neuromuscular artifact that cannot be readily eliminated, arrhythmia, indistinct QRS onset, low amplitude T wave, merged T and U waves, prominent U waves).
• Evidence of atrial fibrillation, atrial flutter, complete left or right bundle branch block (LBBB/RBBB), incomplete LBBB, incomplete RBBB, Wolf Parkinson White syndrome, or cardiac pacemaker at screening or baseline visit (Day 1 pre-dose) (note: a first-degree heart block with PR not exceeding 250 ms can be allowed).
• For Part 3: in elderly participants:
• QTcF \> 450 ms (males); \> 470 ms (females) or \< 300 ms at screening or baseline visit (Day 1 pre dose).

Sponsors & Collaborators

• reMYND: lead

Study Sites (1)

SGS Belgium NV - Clinical Pharmacology Unit

Edegem, 2650, Belgium

Location

Study Design

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

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 11, 2025
• Study Start: March 20, 2025
• Primary Completion: June 23, 2025
• Study Completion: June 23, 2025
• Last Updated: February 4, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)