Clinical Trials

MainTitle

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

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified October 2018 by Viriom

Sponsor
Viriom


Information provided by (Responsible Party)
Viriom
ClinicalTrials.gov Identifier
NCT03706911

First received: October 11, 2018
Last updated: October 15, 2018
Last Verified: October 2018
History of Changes
Purpose

Purpose

This is a study to evaluate safety, tolerability and pharmacokinetics of VM-1500A-LAI single and multiple ascending doses in healthy subjects. The study will be conducted in 1 investigational site in Russia in healthy volunteers.

Condition Intervention Phase
HIV-1-infection

Drug : VM-1500A-LAI
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Study to Evaluate Safety, Tolerability and Pharmacokinetics of VM-1500A-LAI Single and Multiple Ascending Doses in Healthy Subjects

Further study details as provided by Viriom:

Primary Outcome Measures

  • The incidence of AEs and SAEs [ Time Frame: 4 weeks for SAD, 8 weeks for MAD ]
    The incidence of adverse events (AEs) and serious adverse events (SAEs)
Secondary Outcome Measures:
  • concentration of VM1500A in plasma [ Time Frame: 8 weeks ]
  • concentration of VM1500A in BFE [ Time Frame: 8 weeks ]
  • concentration of VM1500A in PBMC [ Time Frame: 8 weeks ]

Estimated Enrollment: 42
Study Start Date: December 2018
Estimated Study Completion Date: February 2020
Estimated Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: VM-1500A-LAI 50mg
VM-1500A-LAI 50mg IM single dose
Drug: VM-1500A-LAI

VM1500A (parent drug of elsulfavirine) IM injection dosage form

Other Name:
  • VM1500A-LAI
  • VM1500A
  • VM-1500A

Experimental: VM-1500A-LAI 150mg
VM-1500A-LAI 150mg IM single dose
Drug: VM-1500A-LAI

VM1500A (parent drug of elsulfavirine) IM injection dosage form

Other Name:
  • VM1500A-LAI
  • VM1500A
  • VM-1500A

Experimental: VM-1500A-LAI 300mg
VM-1500A-LAI 300mg IM single dose
Drug: VM-1500A-LAI

VM1500A (parent drug of elsulfavirine) IM injection dosage form

Other Name:
  • VM1500A-LAI
  • VM1500A
  • VM-1500A

Experimental: VM-1500A-LAI 600mg
VM-1500A-LAI 600mg IM single dose
Drug: VM-1500A-LAI

VM1500A (parent drug of elsulfavirine) IM injection dosage form

Other Name:
  • VM1500A-LAI
  • VM1500A
  • VM-1500A

Experimental: VM-1500A-LAI 1200mg
VM-1500A-LAI 1200mg IM single dose
Drug: VM-1500A-LAI

VM1500A (parent drug of elsulfavirine) IM injection dosage form

Other Name:
  • VM1500A-LAI
  • VM1500A
  • VM-1500A

Experimental: VM-1500A-LAI XXX5mg Multiple
VM-1500A-LAI selected dose IM, 2 injections monthly
Drug: VM-1500A-LAI

VM1500A (parent drug of elsulfavirine) IM injection dosage form

Other Name:
  • VM1500A-LAI
  • VM1500A
  • VM-1500A

Experimental: VM-1500A-LAI XXX6mg Multiple
VM-1500A-LAI double selected dose IM, 2 injections monthly
Drug: VM-1500A-LAI

VM1500A (parent drug of elsulfavirine) IM injection dosage form

Other Name:
  • VM1500A-LAI
  • VM1500A
  • VM-1500A

Detailed Description:

This is a study to evaluate safety, tolerability and pharmacokinetics of a long-acting injectable NNRTI VM-1500A-LAI single and multiple ascending doses in healthy subjects. The study will be conducted in 1 investigational site in Russia in healthy volunteers.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 45 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  

Criteria

Inclusion Criteria:

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


Exclusion Criteria:
    1. Chronic diseases of cardiovascular, bronchopulmonary, neuroendocrine, musculoskeletal system and gastrointestinal tract, as well as immunologic, liver, kidneys, blood diseases;
    2. Deviations of laboratory parameters from normal values at screening (the acceptable limits of laboratory parameters are specified in Annex 1), as well as deviations from the normal values on the ECG results;
    3. Systolic pressure less than 90 mm Mercury or above 130 mm Mercury, diastolic pressure less than 60 mm Mercury or above 85 mm Mercury, heart rate less than 60 BPM or more than 90 BPM at screening;
    4. Regular intake of drugs less than 2 weeks prior to screening (including herbal preparations and dietary supplements); intake of drugs that have a pronounced effect on hemodynamics, liver, kidney and CNS function and etc. (for example, barbiturates, omeprazole, cimetidine, etc.) less than 4 weeks prior to screening;
    5. Presence of antibodies to HIV and hepatitis C virus, presence of hepatitis В surface antigen, a positive syphilis test;
    6. Presence of an unstable sleep structure (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; cigarettes smoking 3 months prior to screening; positive drug and alcohol test at screening;
    8. Presence of depression episodes or other mental disorders/conditions that require medical therapy in history;
    9. Burdened allergic medical history (including drug intolerance and food allergy);
    10. Blood/plasma donation (450 ml of blood or plasma and more) less than 12 months prior to screening, surgery;
    11. Presence of diseases and conditions in the present or past, including surgery, which, according to the Investigator, may affect the absorption, distribution, metabolism or excretion of the study drug;
    12. Participation in other clinical studies or taking other study drugs 3 months before screening;
    13. Acute infectious diseases less than 4 weeks prior to screening;
    14. Incapable of reading or writing; no desire to understand and adhere to the study
    protocol procedures; non-compliance with the drugs intake regimen or execution of procedures, which as the Investigator may think may affect the study results or subject's safety and prevent the subject from further participation in the study; any other associated medical or serious psychological conditions making the subject not eligible to participate in the clinical study, restricting legality of obtaining the informed consent or affecting the subject's ability to take part in the study.

contacts and locations

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03706911

Contacts

Contact:   Elena Yakubova, PhD +7 (495) 995-49-44 ey@chemrar.ru
Contact:   Vladimir Kan, PhD 7 (495) 995-49-44 vkan@chemrar.ru

Locations

Russian Federation
I.M. Sechenov First Moscow State Medical University Not yet recruiting
Moscow, Russian Federation, 119146
Contact: Elena Smolyarchuk, PhD    +7 499 248 6479
Principal Investigator: Elena Smolyarchuk, PhD

Sponsors and Collaborators

Viriom

Investigators

Principal Investigator: Elena Smolyarchuk, PhD I.M. Sechenov First Moscow State Medical University
More Information

More Information


Responsible Party: Viriom  
ClinicalTrials.gov Identifier: NCT03706911   History of Changes  
Other Study ID Numbers: HIV-VM1500ALAI-01  
Study First Received: October 11, 2018  
Last Updated: October 15, 2018  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by Viriom:

HIV-1

ClinicalTrials.gov processed this data on October 15, 2019
This information is provided by ClinicalTrials.gov.