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

A Phase 1 study testing VM-1500A-LAI in people with HIV-1-infection, run by Viriom at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To evaluate safety and tolerability of VM-1500A-LAI after its single and multiple intramuscular ascending dose to healthy volunteers Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: HIV-1-infection
What is being tested?: VM-1500A-LAI
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteRussia
Study dates: 21 Jan 2019to 18 May 2020
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Non-smoking healthy male subjects aged 18 - 45 years (inclusive);
Verified "healthy" status, based on standard clinical, laboratory, and instrumental examination methods;
Body weight ≥ 50 kg and Body Mass Index in the range from 18.5 to 30.0 kg/m2;
Signed the Participant Explanation Sheet and the Informed Consent Form;
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).

Who cannot join

Chronic cardiovascular, bronchopulmonary, neuroendocrine, musculoskeletal or gastrointestinal diseases, as well as immunologic, hepatic, renal, or blood diseases;
Laboratory abnormalities, or ECG abnormalities at Screening;
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;
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;
Presence of antibodies to HIV or hepatitis C virus, presence of hepatitis В surface antigen, positive syphilis test;
Unstable sleeping (for example, night work, sleep disturbances, insomnia, recent return from another time zone, etc.);

Show all 15Show fewer

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;
Depression episodes or other mental disorders/conditions in medical history that required therapy
Allergy in medical history (including drug intolerance and food allergy);
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;
Blood/plasma donation (450 ml or more of blood/plasma) or surgical intervention within 12 months before Screening;
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);
Participation in other clinical studies or therapy with other study drugs within 3 months before Screening;
Acute infectious diseases within 4 weeks before Screening;
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.

Trial locations and contacts

1 site in 1 country.

Russia1 site

Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)
Moscow, 119991

Other trials in Russia

About this study

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

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

Read the 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

Conditions: HIV-1-infection
Being tested: VM-1500A-LAI
Keywords: HIV-1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VM-1500A-LAIDrug
Also called VM-1500, VM-1500A
VM-1500A (parent drug of elsulfavirine) IM injection dosage form

Study groups in NCT03706911
Study group	Role	What they receive
VM-1500A-LAI 150mg	Experimental	VM-1500A-LAI 150mg IM single dose Receives: Drug: VM-1500A-LAI
VM-1500A-LAI 300mg	Experimental	VM-1500A-LAI 300mg IM single dose Receives: Drug: VM-1500A-LAI
VM-1500A-LAI 600mg	Experimental	VM-1500A-LAI 600mg IM single dose Receives: Drug: VM-1500A-LAI
VM-1500A-LAI 1200mg	Experimental	VM-1500A-LAI 1200mg IM single dose Receives: Drug: VM-1500A-LAI
VM-1500A-LAI 600 mg Multiple	Experimental	VM-1500A-LAI Multiple dose (2 injections every 4 weeks) Receives: Drug: VM-1500A-LAI

What is being measured

The primary outcome is the main question the study is designed to answer.

The incidence of AEs and SAEs. Concentration of VM1500A in plasma and RBCs
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.
Measured: 4 weeks for SAD, 8 weeks for MAD

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jan 201918 May 2020

First posted16 Oct 2018
Study start21 Jan 2019
Primary completion27 Mar 2020
Study completion18 May 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIV-1-infectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03706911
Sponsor's protocol ID: HIV-VM1500ALAI-01
Status last verified: Dec 2021
First submitted: 11 Oct 2018
Last updated: 15 Dec 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV-1-infection trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03706911
Acronym / sponsor ID: HIV-VM1500ALAI-01
Conditions: HIV-1-infection
Keywords: HIV-1
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: ViriomIndustry (pharma, biotech, devices)
Study start: 21 Jan 2019 (actual)
Primary completion: 27 Mar 2020 (actual)
Study completion: 18 May 2020 (actual)
First posted: 16 Oct 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
VM-1500A-LAI 150mg	Experimental	Drug: VM-1500A-LAIVM-1500A-LAI 150mg IM single dose
VM-1500A-LAI 300mg	Experimental	Drug: VM-1500A-LAIVM-1500A-LAI 300mg IM single dose
VM-1500A-LAI 600mg	Experimental	Drug: VM-1500A-LAIVM-1500A-LAI 600mg IM single dose
VM-1500A-LAI 1200mg	Experimental	Drug: VM-1500A-LAIVM-1500A-LAI 1200mg IM single dose
VM-1500A-LAI 600 mg Multiple	Experimental	Drug: VM-1500A-LAIVM-1500A-LAI Multiple dose (2 injections every 4 weeks)

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Non-smoking healthy male subjects aged 18 - 45 years (inclusive);
Verified "healthy" status, based on standard clinical, laboratory, and instrumental examination methods;
Body weight ≥ 50 kg and Body Mass Index in the range from 18.5 to 30.0 kg/m2;
Signed the Participant Explanation Sheet and the Informed Consent Form;
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).

Key exclusion criteria (15 listed)

Chronic cardiovascular, bronchopulmonary, neuroendocrine, musculoskeletal or gastrointestinal diseases, as well as immunologic, hepatic, renal, or blood diseases;
Laboratory abnormalities, or ECG abnormalities at Screening;
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;
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;
Presence of antibodies to HIV or hepatitis C virus, presence of hepatitis В surface antigen, positive syphilis test;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VM-1500A-LAIAlso: VM-1500, VM-1500AVM-1500A (parent drug of elsulfavirine) IM injection dosage form	Drug	VM-1500A-LAI 1200mg, VM-1500A-LAI 150mg, VM-1500A-LAI 300mg, VM-1500A-LAI 600 mg Multiple, VM-1500A-LAI 600mg

Primary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
Individual participant dataSharing planned: No

Related trials for HIV-1-infection

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Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
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RecruitingObservational study
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Active, not recruitingPhase 2/3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elena Smolyarchuk, PhD principal investigator

I.M. Sechenov First Moscow State Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VM-1500A-LAI in people with HIV-1-infection, run by Viriom at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of AEs and SAEs. Concentration of VM1500A in plasma and RBCs (time frame: 4 weeks for SAD, 8 weeks for MAD). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03706911.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2021.