A Phase 1, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of REM0045392 to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Food Effect in Healthy Male Participants and in a Panel of Healthy Elderly Participants (Both Sexes)
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.
• 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.