Evaluation of safety and tolerability of JM-20 in healthy volunteers. Clinical trial Phase I.

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

JM-20

Scientific title:

Phase I, dose-escalation, monocentric, adaptive, double-blind, placebo-controlled, randomized clinical trial to evaluate the safety and tolerability of JM-20 at single and repeated doses in healthy volunteers.

Acronym of Scientific Title:

JM-20

Secondary indentifying numbers:

EC00124

Issuing authority of the secondary identifying numbers:

Center for Pharmaceutical Research and Development (CIDEM)

Source(s) of monetary or material support:

Center for Pharmaceutical Research and Development (CIDEM)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Carlos

Midle name:

Alberto

Last name:

Gonzalez Delgado

Medical Specialty :

Second Degree Specialist in Pharmacology

Affiliation:

National Toxicology Center (Cenatox)

Postal address:

Ave. 31 y Calle 114. Marianao

City:

Havana

País:

Cuba

Zip Code:

11500

Telephone:

+53-59113299

+53-72743282

Email address:

eclinicos@infomed.sld.cu

carglez@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

30/09/2025

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Parkinson's disease and mild and moderate cognitive impairment

Intervention(s):

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 dose of placebo will be administered orally to 2 volunteers. Group 2 Group JM-20, 80 mg (Experimental): A single dose of 80 mg of JM-20 will be administered orally to 6 volunteers, Placebo Group (Control): A single dose of placebo will be administered orally to 2 volunteers Group 3 Group JM-20, 140 mg (Experimental): A single dose of 140 mg of JM-20 will be administered orally to 6 volunteers, Placebo Group (Control): A single dose of placebo will be administered orally to 2 volunteers Group 4 Group JM-20, 200 mg (Experimental): A single dose of 200 mg of JM-20 will be administered orally to 6 volunteers, Placebo Group (Control): A single dose of placebo will be administered orally to 2 volunteers If no adverse events occur in Group 4, two additional Groups (Group A and Group B) will be included at two higher dose levels, each with eight subjects, and equal distribution for the experimental (n=6) and control (n=2) groups. The doses will be 280 and 380 mg, respectively, after exhaustive evaluation by the Independent Data Monitoring Committee (IDMC). Stage II dose escalation design repeated every 12 hours for 21 days. Group 5 Group JM-20 40 mg (Experimental): A dose of 40 mg of JM-20 will be administered orally every 12 hours for 21 days to 6 volunteers, Placebo Group (Control): A placebo dose will be administered orally every 12 hours for 21 days to 2 volunteers. Group 6 Group JM-20 100 mg (Experimental): A dose of 100 mg of JM-20 will be administered orally every 12 hours for 21 days to 6 volunteers, Placebo Group (Control): A placebo dose will be administered orally every 12 hours for 21 days to 2 volunteers Group 7 Group JM-20 200 mg (Experimental): A dose of 200 mg of JM-20 will be administered orally every 12 hours for 21 days to 6 volunteers, Placebo Group (Control): A placebo dose will be administered orally every 12 hours for 21 days to 2 volunteers.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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 volunteers with abnormalities will be measured). Measurement time: Stage I: At baseline and at 2, 4, 8, and 12 hours post-administration, on days 1, 2, 3, 4, 6, 7, and 14 in the morning. Stage II: At baseline and at 2, 4, and 8 hours after the first dose of the day and 2 hours after the second dose; on days 1, 2, 3, 4, 5, 6, 7, 14, and 21 in the morning before the first dose of the day and at 2 hours after each administration and on day 35. 6. Abdominal ultrasound (The percentage of volunteers with liver abnormalities will be measured). Measurement time: Stage I: At baseline and on days 7 and 14. Stage II: At baseline and on days 7, 14, 21, and 35. 7. Cognitive Impairment (The percentage of volunteers with cognitive deficits will be measured using the Mini-Mental State Examination (MMSE) questionnaire). Measurement time: Stage I: At baseline (within 60 minutes before administration), 4 and 24 hours after administration. Stage II: At baseline (within 60 minutes before administration) and 4 hours after administration of the first dose of the day. On days 1, 3, 5, 7, 14, and 21, 4 hours after the first dose of the day, and on day 35. 8. Glasgow Coma Scale (Assessment of the level of consciousness by assessing eye opening, verbal response, and motor response. The percentage of volunteers with altered levels of consciousness will be measured.) Measurement time: Stage I: Daily during hospitalization and on day 14. Stage II: Daily during hospitalization and on days 21 and 35. 9. Concomitant treatment (The name of the concomitant medication and the treatment regimen will be recorded.) Measurement time: Stage I: Daily during hospitalization and on day 14. Stage II: Daily during hospitalization and on days 21 and 35.

Key secondary outcomes:

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)

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

59 years

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:

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. Subjects with difficulties attending scheduled follow-up visits. 23. Subjects with positive results for HIV, hepatitis C antibodies, hepatitis B surface antigen, and VDRL serology

Type of population:

Adults

Type of participant:

Healthy volunteers

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

1

Target sample size:

68

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Zenia

Middle Name:

Maria

Last Name:

Lazo Gonzalez

Specialty:

First degree Specialist in Comprehensive General Medicine and, Hygiene and Epidemiology

Affiliation:

Center for Pharmaceutical Research and Development (CIDEM)

Postal Address:

Ave 26 No. 1605 e/ Boyeros y Ave.51 Plaza de la Revolucion

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-72152192

Email :

zenia.lazo@cidem.cu

zeniala@infomed.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Carlos

Middle Name:

Alberto

Last Name:

Delgado Gonzalez

Specialty:

Second Degree Specialist in Pharmacology

Affiliation:

National Toxicology Center (Cenatox)

Postal Address:

Ave. 31 y Calle 114. Marianao

City:

Havana

País:

Cuba

Zip Code:

11500

Telephone:

+53-72743282

Email :

carglez@infomed.sld.cu

eclinicos@infomed.sld.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

National Toxicology Center (Cenatox)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

10/03/2025

Postal address of Ethic Committee :

Ave. 31 y Calle 114. Marianao. La Habana. CP 11500. Cuba.

Telephone:

+53-72073605

Correo electrónico:

fleites@gmail.com

About study completion

Section to complete the data related to the study completion.

Study completion date:

04/02/2027

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000460

Date of Registration in Primary Registry:

16/07/2025

Record Verification Date:

2025/07/17

Next update date:

2026/07/17

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Evaluation of safety and tolerability of JM-20 in healthy volunteers. Clinical trial Phase I.

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