Viriom has commenced the Phase I HIV-VM1500ALAI-01 clinical study designed to assess the safety, tolerability and pharmacokinetics of VM1500A in HIV-uninfected individuals.
VM1500A is a new nonnucleoside reverse transcriptase inhibitors (NNRTI) with the ability to target activities across HIV-1 variants.
Viriom will evaluate single and multiple ascending doses of VM-1500A-LAI as part of the open-label trial,.
The study is being conducted at a single site in Moscow, Russia, and aims to randomise 36 healthy subjects into one of the trial’s six dosing cohorts.
Subjects will receive a daily oral dose of 20m elsulfavirine during a two-week run-in period.
Elsulfavirine is a nonnucleoside reverse transcriptase inhibitor (NNRTI) pro-drug developed for oral bioavailability and broad-spectrum activity against HIV-1.
Participants will receive a single intramuscular injection of VM-1500A-LAI upon completion of the run-in period.
The trial also includes a four-week follow-up period for various assessments including PK for each subject.
The Safety Review Committee (SRC) will then review the data to recommend whether to move to the next dose level.
Two dose levels will be selected for the trial’s next multiple administration cohorts based on results from the single ascending dose part of the HIV-VM1500ALAI-01 trial.
Viriom president and executive chairman Nikolay Savchuk said: “This trial is an important step in confirming the safety and tolerability of the nanosuspension formulation of VM1500A for long-acting once monthly and potentially less frequent injections.
“After this we will conduct further studies in HIV-infected individuals.
“The expeditious movement of VM1500A into early clinical development Phase I/II trials is an impressive result of the Viriom global team commitment to delivering best in class HIV treatment and prevention.”