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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03706911
Recruitment Status : Unknown
Verified October 2018 by Viriom.
Recruitment status was:  Not yet recruiting
First Posted : October 16, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Viriom

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
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
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • VM1500A-LAI
  • VM1500A
  • VM-1500A




Primary Outcome Measures :
  1. 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 :
  1. concentration of VM1500A in plasma [ Time Frame: 8 weeks ]
  2. concentration of VM1500A in BFE [ Time Frame: 8 weeks ]
  3. concentration of VM1500A in PBMC [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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:   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.

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


Contacts
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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
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Russian Federation
I.M. Sechenov First Moscow State Medical University
Moscow, Russian Federation, 119146
Contact: Elena Smolyarchuk, PhD    +7 499 248 6479      
Principal Investigator: Elena Smolyarchuk, PhD         
Sponsors and Collaborators
Viriom
Investigators
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Principal Investigator: Elena Smolyarchuk, PhD I.M. Sechenov First Moscow State Medical University
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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: October 18, 2018
Last Verified: October 2018
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