Parkinson's disease and mild and moderate cognitive impairment
Conditions
Interventions
Stage I single ascending dose escalation design
Group 1
Group JM-20, 40 mg (Experimental) A single dose of 40 mg of JM-20 will be administered orally to 6 volunteers,
Placebo Group (Control) A single
Sponsors
Center for Pharmaceutical Research and Development (CIDEM)
Eligibility
Sex/Gender
All
Age
19 Years to 59 Years
Inclusion criteria
Inclusion criteria: 1. Voluntariness by expressing in writing your informed consent to participate in the clinical trial 2. Healthy subjects between 19 and 59 years of age. 3. Either sex. 4. Female subjects who: - Are of childbearing potential and use a contraceptive method at least 14 days before the first dose of the investigational product and continue throughout the study, as well as for 28 days after the last dose. Hormonal contraceptive methods are excluded. The decision to use the safest possible contraceptive method will be made by the PI or the clinical investigator responsible for their medical care (the sponsor will offer volunteers condoms and the possibility of access to an intrauterine device (IUD). Clinical investigators will verify and monitor this aspect during the selection or screening process (consent, questioning, and physical examination) and subsequently at each evaluation point during the clinical phase of the study). - Be of childbearing potential and have been surgically sterile (bilateral tubal ligation, hysterectomy, oophorectomy) at least 6 months prior to screening. - Have a history of being postmenopausal with spontaneous amenorrhea for at least 1 year. - Male partners must have a vasectomy history greater than 6 months prior to screening or use a local method of contraception (condom) during sexual activity. 5. Body mass index between 18.5 and 29.9 kg/m2 6. Remain at the clinic for the entire stay and attend all scheduled outpatient visits. 7. Successfully complete the physical examination and laboratory tests
Exclusion criteria
Exclusion criteria: 1. Subject with evidence or history of a chronic non-communicable disease such as bronchial asthma, arterial hypertension, peptic or duodenal ulcer, intestinal malabsorption syndrome, liver failure, kidney failure, cardiovascular disorders, diabetes mellitus, psychotic psychiatric illness, or any other condition that, in the investigator's judgment, would jeopardize the subject's safety or the validity of the study results. 2. Subject with a clinically significant abnormal finding on physical examination, personal medical history, ECG, abdominal US, or clinical laboratory results at the screening stage. Note: Subjects with abnormal clinical laboratory results, not specifically excluded by this protocol, may be included if the investigator considers that the values outside the CIMEQ laboratory's reference range are not clinically significant (See section 8.1.1.1 Clinical significance of complementary diagnostic test results). 3. History of allergy or known hypersensitivity to the study drugs, or to any of the components of the formulations studied. 4. Subjects with a history of lactose intolerance (an excipient present in the formulation components). 5. Female subjects with a positive pregnancy test result or regular unprotected sex. 6. Presence of mental and/or psychiatric disorders that make it impossible to sign the IC or monitor the volunteer. 7. Subjects with a febrile or acute infectious illness within 7 days prior to administration of the product. 8. Subjects with a congenital or acquired immune system disease. 9. Subjects with a history of neoplastic disease. 10. Subjects with a history of sleep apnea. 11. Subjects with a history of drug dependence or substance abuse within the past 30 days, or a substance-related addiction, except smoking. 12. Subjects with a history of severe allergic disease (anaphylactic shock, angioedema, glottic edema, severe urticaria). 13. Participation in another clinical trial for preventive or therapeutic intervention within the past 3 months. 14. Taking any medication 15 days (or for 5 half-lives) before the first dose of the investigational products, or non-prescription or over-the-counter medications (OTC drugs), or herbal medications/dietary supplements within a period of seven days before the first dose of the investigational products and through the end of the study. 15. Treatment with immunomodulators within the past 30 days, e.g. steroids (except for occasional topical or inhaled steroids), cytostatics, interferon, immunoferon, transfer factor, monoclonal antibodies, biomodulin T, any gamma globulin, levamisole, heberferon, thymosin) or those who are expected to require immunomodulatory treatment due to their underlying disease, which may coincide with the study. 16. History of bleeding disorders or coagulopathies such as epistaxis, rectal bleeding, and gingival bleeding within the 3 months prior to the start of the study. 17. History of alcoholism in the last 6 months (consumption of at least ¼ bottle of rum or one (1) bottle of wine or three (3) beers, more frequently than twice a week). 18. History of receiving a blood transfusion or blood products in the last 3 months. 19. Having donated blood or plasma within 30 days prior to the first dose of the investigational product. 20. Having undergone major surgery in the 6 months prior to the start of the study. 21. Having participated in a clinical trial in the last 6 months. 22. Subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of Adverse Events-AE (Occurrence of AE (yes, no); Name of AE (adverse event description); Duration of AE (start time, end time); Intensity of AE (mild, moderate, severe, life-threatening, death); Severity of AE (serious, non-serious); Causal relationship (definitive, probable, possible, unrelated/doubtful, conditional/unclassified, non-evaluable/unclassifiable); Conduct to AE (none, temporary interruption, permanent interruption, pharmacological treatment, non-pharmacological treatment); Outcome (recovered, improved, persists, sequelae)). Measurement time: During the period after administration and up to 14 days after the last dose. 2. Tolerability assessment (Evaluation will include: Death (yes, no); AEs leading to discontinuation or interruption of treatment (yes, no); AEs requiring concomitant treatment (yes, no); AEs requiring hospitalization of the subject (yes, no)). Measurement time: During treatment and up to 14 days after the last dose. 3. Clinical laboratory tests (The percentage of volunteers with variations outside the reference range for hematological and biochemical parameters will be measured). Measurement time: Stage I: At baseline and at 14 days. Stage II: At baseline and at days 21 and 35. 4. Vital signs (The percentage of volunteers with variations outside the reference range for systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and temperature will be measured). Measurement time: In Stage I: At baseline (within 60 minutes before administration) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours after administration; every 8 hours on days 1 through 6; on day 7 before hospital discharge; and on day 14 at the final visit. Stage II: At baseline (within 60 minutes before administration) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours after administration; every 8 hours on days 1 through 21; on day 22 before hospital discharge, and on day 35 at the final visit. 5. Electrocardiogram (The percentage of v | — |
Secondary
| Measure | Time frame |
|---|---|
| Inhibition of acetylcholinesterase enzyme activity (The percentage of volunteers with variations outside the reference range for plasma and erythrocyte AChE will be measured). Measurement time: Screening phase for both stages. Stage I: At baseline, days 1, 3, 7, and 14 days after end of treatment. Stage II: At baseline, days 1, 3, 7, 14, 21, and 14 days after end of treatment (day 35) | — |
Countries
Cuba
Contacts
Public ContactZenia Lazo Gonzalez
Center for Pharmaceutical Research and Development (CIDEM)
Outcome results
None listed