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Study to Evaluate Safety, Tolerability and Pharmacokinetics of VM-1500A-LAI Single and Multiple Ascending Doses in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03706911
Recruitment Status : Completed
First Posted : October 16, 2018
Last Update Posted : December 15, 2021
Sponsor:
Information provided by (Responsible Party):
Viriom

Study Description
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Brief Summary:
To evaluate safety and tolerability of VM-1500A-LAI after its single and multiple intramuscular ascending dose to healthy volunteers

Condition or disease Intervention/treatment Phase
HIV-1-infection Drug: VM-1500A-LAI Phase 1

Detailed Description:

Primary Objective:

To evaluate safety and tolerability of VM-1500A-LAI after its single and multiple intramuscular ascending dose to healthy volunteers.

Secondary Objectives:

To evaluate pharmacokinetic parameters of VM-1500A after its single and multiple intramuscular ascending dose administration to healthy volunteers.

To evaluate safety and tolerability of ELPIDA®, administered in the run-in period

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study to Evaluate Safety, Tolerability and Pharmacokinetics of VM-1500A-LAI After Single and Multiple Ascending Dose Administration to Healthy Volunteers
Actual Study Start Date : January 21, 2019
Actual Primary Completion Date : March 27, 2020
Actual Study Completion Date : May 18, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV

Arms and Interventions
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Arm Intervention/treatment
Experimental: VM-1500A-LAI 150mg
VM-1500A-LAI 150mg IM single dose
 Drug: VM-1500A-LAI
VM-1500A (parent drug of elsulfavirine) IM injection dosage form
Other Names:
  • VM-1500
  • VM-1500A
Experimental: VM-1500A-LAI 300mg
VM-1500A-LAI 300mg IM single dose
 Drug: VM-1500A-LAI
VM-1500A (parent drug of elsulfavirine) IM injection dosage form
Other Names:
  • VM-1500
  • VM-1500A
Experimental: VM-1500A-LAI 600mg
VM-1500A-LAI 600mg IM single dose
 Drug: VM-1500A-LAI
VM-1500A (parent drug of elsulfavirine) IM injection dosage form
Other Names:
  • VM-1500
  • VM-1500A
Experimental: VM-1500A-LAI 1200mg
VM-1500A-LAI 1200mg IM single dose
 Drug: VM-1500A-LAI
VM-1500A (parent drug of elsulfavirine) IM injection dosage form
Other Names:
  • VM-1500
  • VM-1500A
Experimental: VM-1500A-LAI 600 mg Multiple
VM-1500A-LAI Multiple dose (2 injections every 4 weeks)
 Drug: VM-1500A-LAI
VM-1500A (parent drug of elsulfavirine) IM injection dosage form
Other Names:
  • VM-1500
  • VM-1500A


Outcome Measures
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Primary Outcome Measures :
  1. The incidence of AEs and SAEs. Concentration of VM1500A in plasma and RBCs [ Time Frame: 4 weeks for SAD, 8 weeks for MAD ]
    The incidence of adverse events (AEs) and serious adverse events (SAEs). This is an open-label study aimed to evaluate safety, tolerability, and pharmacokinetics of VM-1500A-LAI administered as single or multiple ascending doses to healthy volunteers.


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Healthy male volunteers will be included in this study
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Non-smoking healthy male subjects aged 18 - 45 years (inclusive);
  2. Verified "healthy" status, based on standard clinical, laboratory, and instrumental examination methods;
  3. Body weight ≥ 50 kg and Body Mass Index in the range from 18.5 to 30.0 kg/m2;
  4. Signed the Participant Explanation Sheet and the Informed Consent Form;
  5. Consent to use an adequate method of contraception throughout the study and 3 months after its completion: a condom with spermicide substance (cream, foam or suppository).

Exclusion Criteria:

  1. Chronic cardiovascular, bronchopulmonary, neuroendocrine, musculoskeletal or gastrointestinal diseases, as well as immunologic, hepatic, renal, or blood diseases;
  2. Laboratory abnormalities, or ECG abnormalities at Screening;
  3. Systolic arterial pressure less than 90 mm Hg or above 130 mm Hg, diastolic arterial pressure less than 60 mm Hg or above 85 mm Hg, heart rate less than 60 BPM or more than 90 BPM at Screening;
  4. Regular intake of drugs within 2 weeks before Screening (including herbal preparations and dietary supplements); intake of drugs that have a pronounced effect on hemodynamics, liver, kidney, or CNS function, etc. (for example, barbiturates, omeprazole, cimetidine, etc.) within 4 weeks before Screening;
  5. Presence of antibodies to HIV or hepatitis C virus, presence of hepatitis В surface antigen, positive syphilis test;
  6. Unstable sleeping (for example, night work, sleep disturbances, insomnia, recent return from another time zone, etc.);
  7. Signs of alcohol (taking more than 10 units of alcohol per week) or drug addiction; alcohol or drugs consumption within 7 days prior to Screening; smoking within 3 months before Screening; positive drug or alcohol test at Screening;
  8. Depression episodes or other mental disorders/conditions in medical history that required therapy
  9. Allergy in medical history (including drug intolerance and food allergy);
  10. Hypersensitivity to the active substance or to any other ingredient of the study drug. Sucrose intolerance, sucrase-isomaltase deficiency, sucrose isomaltose malabsorption, lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
  11. Blood/plasma donation (450 ml or more of blood/plasma) or surgical intervention within 12 months before Screening;
  12. Diseases and conditions (current or in medical history), including surgical intervention, which, according to the opinion of Investigator, may affect the absorption, distribution, metabolism, or excretion of the study drug (excluding appendectomy);
  13. Participation in other clinical studies or therapy with other study drugs within 3 months before Screening;
  14. Acute infectious diseases within 4 weeks before Screening;
  15. Subjects unable to read or write; unwillingness to understand and follow to the procedures, defined in the Study Protocol; non-compliance with the dosing regimen or procedures, which according to the opinion of Investigator, may affect the study results or safety of study subject and prevent the subject from further participation in the study; any other associated medical or serious mental conditions making the subject not eligible to participate in the clinical study, restricting validity of obtaining the informed consent or affecting the subject's ability to participate in the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706911


Locations
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Russian Federation
Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)
Moscow, Russian Federation, 119991
Sponsors and Collaborators
Viriom
Investigators
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Principal Investigator: Elena Smolyarchuk, PhD I.M. Sechenov First Moscow State Medical University
More Information
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Responsible Party: Viriom
ClinicalTrials.gov Identifier: NCT03706911    
Other Study ID Numbers: HIV-VM1500ALAI-01
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: December 15, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Viriom:
HIV-1