Safety Tolerability and Pharmacokinetics of Inhaled Nanoparticle Formulation of Remdesivir (GS-5734) and NA-831

  • STATUS
    Recruiting
  • participants needed
    45
  • sponsor
    NeuroActiva, Inc.
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Updated on 16 February 2024
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HIV Infection
hysterectomy
oophorectomy
tubal ligation
hepatitis b surface antigen
hepatitis
bilateral oophorectomy
immunodeficiency
hepatitis c
remdesivir

Summary

The clinical study is designed to evaluate the safety, tolerability and pharmacokinetics of inhaled nanoparticle nanoparticle formulation of Remdesivir (GS-5734) alone and in combination with NA-831 in 48 healthy volunteers.

Description

It has been discovered that SARS-CoV-2 viruses (Covid-19) can directly invade the nervous system of patients, instead of injuring the nervous system through the immune response. Neurotropism is one common feature of Covid-19. Such neuro-invasive propensity of Covid-19 has been documented almost for all the Beta-coronaviruses including SARSCoV and MERSCoV.

Increasing evidence suggests that infection with Sars-CoV-2 causes neurological deficits in a substantial proportion of affected patients. It was observed that patients surviving COVID-19 are at high risk for subsequent development of neurological disease and in particular Alzheimer's disease.

NA-831 is a new neuroprotective and neurogenesis drug that has been demonstrated its promising safety and efficacy in Phase 2A for the treatment of early onset of Alzheimer's disease. NA-831 in oral formulation is well tolerated NA-831 with no adverse effects. NA-831 in oral formulation exhibits predictable pharmacokinetics including dose-dependent exposure linearity and low variability.

Based on animal studies, NA-831 can provide effective interventions during the severe acute respiratory syndrome, and provide appropriate rehabilitation measures afterwards.

Remdesivir (GS-5734) intravenous formulation has been approved by the FDA under the emergency use authorization for potential treatment of severe cases of Covid-19.

It was found the upper respiratory tract is the most prevalent site of SARS-CoV-2 infection early in disease. Delivering drugs directly to the primary site of infection with a nebulizer, inhaled nanoparticle formulation may enable more targeted and accessible administration in non-hospitalized patients and potentially lower systemic exposure to the drug.

The study is designed to evaluate the safety, tolerability and pharmacokinetics of a new nanoparticle formulation of Remdesivir (GS-5734) and combination therapy with NA-831 in healthy volunteers.

Details
Condition Upper respiratory infection, Nerve Degeneration, Severe Acute Respiratory Syndrome, COVID19, Corona Virus Infection, Severe Acute Respiratory Infection, Severe Acute Respiratory Syndrome (SARS) Pneumonia, Severe Acute Respiratory Syndrome of Upper Respiratory Tract, Neuroinflammatory Response
Age 21years - 50years
Treatment Drug: NA-831 - 0.10 mg/kg, Placebo- 0.10 mg/kg, Drug: NA-831 - 0.20 mg/kg, Placebo- 0.20 mg/kg, Drug: GS-5734 - 1.00 mg/kg, Placebo- 1.00 mg/kg, Drug: GS-5734 - 2.00 mg/kg, Placebo- 2.00 mg/kg, Drugs: NA-831 (0.10 mg/kg) plus GS-5734 (1.00 mg/kg), Placebo 0.10 mg + 1.00 mg/kg, Drugs: NA-831 (0.20 mg/kg) plus GS-5734 (2.00 mg/kg), Placebo 0.20 mg + 2.00 mg/kg
Clinical Study IdentifierNCT04480333
SponsorNeuroActiva, Inc.
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Healthy adult volunteers, aged 21 to 50 years old, men or women
Subjects negative for human immunodeficiency virus (HIV antibody screen), Hepatitis B virus surface Antigen (HBsAg) and Hepatitis C virus (HCV antibody screen)
Subjects who are willing to comply with the requirements of the study protocol, attend scheduled visits and make themselves available for the duration of the study with access to a consistent means of telephone contact
Subjects who give written informed consent approved by the Internal Review Board governing the site
Satisfactory baseline medical assessment as assessed by physical examination and a stable health status. Normal laboratory values must be within normal range of the assessing site or show minor variations that are deemed not clinically significant as judged by the Investigator and acceptable for study entry
Accessible vein in the forearm for blood collection
Female subjects of childbearing potential may be enrolled in the study if they have negative urine pregnancy tests on the day of screening and day of admission
Female subjects of non-childbearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause
Both male (if he has a partner of childbearing potential) and female subjects (of childbearing potential) must agree to use adequate and reliable contraceptive measures (e.g. spermicides, condoms, contraceptive pills, etc.) or practice abstinence throughout the duration of the study (up to 30 days post-dosing)

Exclusion Criteria

Subject previously diagnosed with COVID-19 or had been issued with a quarantine order by the Center of Disease Control (CDC)
Presence of acute infection in the preceding 14 days, or presence of a temperature 100.0 F (oral or tympanic temperature assessment), or acute symptoms of any severity on the scheduled date of admission
History of severe drug and / or food allergies and / or known allergies to the trial product or its components
Female subject who is pregnant or breast-feeding
History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, , or immunosuppressive disorders
Any neurological disease or history of significant neurological disorder (e.g. meningitis, seizures, multiple sclerosis, vasculitis, migraines, Guillain-Barr syndrome [genetic/congenital or acquired])
Evidence of clinically significant anemia (HB < 10 g/dL) or any other significant active hematological disease, or having donated > 450 mL of blood within the past three (3) months
Participation or planned participation in a study involving the administration of an investigational compound within the past four (4) months or during this study period
Receipt of immunoglobulins and/or any blood products within nine (9) months of study enrolment or planned administration of any of these products during the study period
Evidence of Hepatitis B or C or HIV by laboratory testing
A positive test result for drugs of abuse (except a positive test result associated with prescription medication that has been reviewed and approved by the investigator) or alcohol at screening
Administration of any licensed vaccine within 30 days before the first study vaccine dose
Both male (if he has a partner of childbearing potential) and female subjects (of childbearing potential) who are unwilling to use adequate contraception or practice abstinence throughout the duration of the study (up to 84 days post-dosing)
Any condition that, in the opinion of the Investigator, would complicate or compromise the study or well-being of the subject
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