Phase I of VLT-015 in Patients With Schizophrenia

• Status: Recruiting
• Trial end date: 2022-10-30
• Target enrollment: 0
• Participant gender: Male

Summary

15 stable patients diagnosed with schizophrenia take 100 mg of VLT-015 once a day, 200 mg of VLT-015 once a day and 200 mg of VLT-015 on two consecutive days with an interval of 24 hours between doses. PK parameters are measured, tolerability and safety of the product are evaluated.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Valentech LLC

Criteria

Inclusion Criteria:

• Male patients aged 18 to 50

• Availability of a voluntarily signed Information Consent (Patient Information Sheet) for participation in this clinical research and further hospitalization;

• The diagnosis of schizophrenia established in the anamnesis

• The patient's stay in remission** based on the decision of the investigator before and after the withdrawal of maintenance therapy.

Criteria determining the state of remission:

• the sum of points of the Positive and Negative Symptom Scale (PANSS) according to positive Marder factor is less than 22 points,

• each item score of the positive Marder factor (delusions, hallucinatory behavior, grandiosity, suspicion, stereotyped thinking, somatic anxiety, unusual thought content, decreased criticism) less than 4 points

• Absence of taking antipsychotic drugs for 5 periods half-life of the drug taken;

• The patient's ability to adequately cooperate (the ability to understand provided information about the clinical trial, readiness for compliance with the requirements of the study protocol);

• Agree to use barrier methods of contraception during the study and within 2 months after completion of the study.

Exclusion Criteria:

1. The presence of contraindications to the use of VLT-015:

• dysfunction of the bone marrow;

• hypersensitivity to VLT-015 and other components of the drug;

• toxic or idiosyncratic granulocytopenia/agranulocytosis in history;

• epilepsy;

• alcohol, drug intoxication and coma;

• collapse, depression of the central nervous system of any etiology;

• severe kidney or heart disease;

• paralytic intestinal obstruction;

• glucose-galactose malabsorption;

• renal or hepatic insufficiency;

2. Patients requiring medication or other concomitant therapies listed in the unacceptable concomitant therapy section;

3. The presence of prostatic hyperplasia or glaucoma in patients;

4. Diseases of the bone marrow in history;

5. Active tuberculosis, cystic fibrosis, systemic connective tissue diseases, oncological processes of any localization;

6. Severe, decompensated or unstable somatic diseases (any diseases or conditions that threaten the patient's life or worsen the prognosis patient, and also make it impossible to conduct a clinical trial);

7. Alcoholism and drug addiction at the present time, or in history;

8. Lack of patient willingness to cooperate, non-compliance of the patient;

9. Participation of the patient in any other clinical study in the last 30 days;

10. Patients planning to stay in the hospital during the study period for reasons other than the purposes of this clinical trial.