Safety, Tolerability and Pharmacokinetics of Inhaled Nanoparticle Formulation of Remdesivir (GS-5734) and NA-831
NCT ID: NCT04480333
Last Updated: 2020-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
45 participants
INTERVENTIONAL
2020-09-15
2021-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
NA-831 cohorts:
0.1 mg/kg NA-831, number of subjects N=2 and 2 subjects on placebos 0.2 mg/kg NA-831, number of subjects N=4 and 2 subjects on placebos 0.5 mg/kg NA-831, number of subjects N=4 and 2 subjects on placebos
GS-5734 cohorts:
1. mg/kg GS-5734, number of subjects N=2 and 2 subjects on placebos
2. mg/kg GS-5734, number of subjects N=4 and 2 subjects on placebos
4 mg/kg GS-5734, number of subjects N=4 and 2 subjects on placebos
NA-831 plus GS-5734 cohorts:
0.1 mg/kg NA-831 plus 1 mg/kg GS-5734, number of subjects N=2 and 2 subjects on placebos 0.2 mg/kg NA-831 plus 2 mg/kg GS-5734, number of subjects N=4 and 2 subjects on placebos 0.5 mg/kg NA-831 plus 4 mg/kg GS-5734, number of subjects N=4 and 2 subjects on placebos.
TREATMENT
TRIPLE
Study Groups
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Drug: NA-831 - 0.10 mg/kg
3 Subjects will take inhaled formulation of NA-831 once a day for 5 days
Drug: NA-831 - 0.10 mg/kg
NA-831 in nanoparticle inhalation formulation
Comparable Placebo- 0.10 mg/kg
3 subjects will take inhaled formulation of placebo once a day for 5 days
Placebo- 0.10 mg/kg
Placebo in nanoparticle inhalation formulation
Drug: NA-831 - 0.20 mg/kg
6 Subjects will take inhaled formulation of NA-831 once a day for 5 days
Drug: NA-831 - 0.20 mg/kg
NA-831 in nanoparticle inhalation formulation
Comparable Placebo- 0.20 mg/kg
3 subjects will take inhaled formulation of placebo once a day for 5 days
Placebo- 0.20 mg/kg
Placebo in nanoparticle inhalation formulation
Drug: GS-5734 - 1.00 mg/kg
3 Subjects will take inhaled formulation of GS-5734 once a day for 5 days
Drug: GS-5734 - 1.00 mg/kg
GS-5734 in nanoparticle inhaled formulation
Comparable Placebo- 1.00 mg.kg
3 Subjects will take inhaled formulation of GS-5734 once a day for 5 days
Placebo- 1.00 mg/kg
Placebo in nanoparticle inhalation formulation
Drug: GS-5734 - 2.00 mg/kg
6 Subjects will take inhaled formulation of GS-5734 once a day for 5 days
Drug: GS-5734 - 2.00 mg/kg
GS-5734 in nanoparticle inhaled formulation
Comparable Placebo - 2.00 mg/kg
3 Subjects will take inhaled formulation of GS-5734 once a day for 5 days
Placebo- 2.00 mg/kg
Placebo in nanoparticle inhaled formulation
Drugs: NA-831 (0.10 mg/kg) plus GS-5734 (1.00 mg/kg)
3 Subjects- will take inhaled formulation NA-831 (0.10 mg/kg) plus GS-5734 (1.00 mg/kg) once/day for 5 days
Drugs: NA-831 (0.10 mg/kg) plus GS-5734 (1.00 mg/kg)
The combined NA-831 and GS-5734 are in nanoparticle inhaled formulation
Placebo- 0.10- mg/kg placebo+1.00 mg mg/kg
3 Subjects - inhaled formulation of placebo once/day for 5 days
Placebo 0.10 mg + 1.00 mg/kg
The combined placebo are in nanoparticle inhaled formulation
Drugs: NA-831( 0.20 mg/kg) + GS-5734 (2.00 mg/kg)
6 Subjects- inhaled formulation of NA-831 (0.20 mg/kg) + GS-5734 (2.00 mg/kg) once/day for 5 days
Drugs: NA-831 (0.20 mg/kg) plus GS-5734 (2.00 mg/kg)
The combined NA-831 and GS-5734 are in nanoparticle inhaled formulation
Placebo- 0.20 mg/kg + 2.00mg/kg
3 Subjects- inhaled formulation of placebo once/day for 5 days
Placebo 0.20 mg + 2.00 mg/kg
Placebo 0.10 mg + 1.00 mg/kg
Interventions
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Drug: NA-831 - 0.10 mg/kg
NA-831 in nanoparticle inhalation formulation
Placebo- 0.10 mg/kg
Placebo in nanoparticle inhalation formulation
Drug: NA-831 - 0.20 mg/kg
NA-831 in nanoparticle inhalation formulation
Placebo- 0.20 mg/kg
Placebo in nanoparticle inhalation formulation
Drug: GS-5734 - 1.00 mg/kg
GS-5734 in nanoparticle inhaled formulation
Placebo- 1.00 mg/kg
Placebo in nanoparticle inhalation formulation
Drug: GS-5734 - 2.00 mg/kg
GS-5734 in nanoparticle inhaled formulation
Placebo- 2.00 mg/kg
Placebo in nanoparticle inhaled formulation
Drugs: NA-831 (0.10 mg/kg) plus GS-5734 (1.00 mg/kg)
The combined NA-831 and GS-5734 are in nanoparticle inhaled formulation
Placebo 0.10 mg + 1.00 mg/kg
The combined placebo are in nanoparticle inhaled formulation
Drugs: NA-831 (0.20 mg/kg) plus GS-5734 (2.00 mg/kg)
The combined NA-831 and GS-5734 are in nanoparticle inhaled formulation
Placebo 0.20 mg + 2.00 mg/kg
Placebo 0.10 mg + 1.00 mg/kg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects negative for human immunodeficiency virus (HIV antibody screen), Hepatitis B virus surface Antigen (HBsAg) and Hepatitis C virus (HCV antibody screen).
3. 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.
4. Subjects who give written informed consent approved by the Internal Review Board governing the site.
5. 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.
6. Accessible vein in the forearm for blood collection.
7. 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.
8. Female subjects of non-childbearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause.
9. 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
2. 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.
3. History of severe drug and / or food allergies and / or known allergies to the trial product or its components.
4. Female subject who is pregnant or breast-feeding.
5. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, , or immunosuppressive disorders.
6. Any neurological disease or history of significant neurological disorder (e.g. meningitis, seizures, multiple sclerosis, vasculitis, migraines, Guillain-Barré syndrome \[genetic/congenital or acquired\]).
7. 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.
8. 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.
9. 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.
10. Evidence of Hepatitis B or C or HIV by laboratory testing.
11. 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.
12. Administration of any licensed vaccine within 30 days before the first study vaccine dose.
13. 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).
14. 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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21 Years
50 Years
ALL
No
Sponsors
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Biomed Industries, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lloyd Tran, PhD
Role: STUDY_DIRECTOR
Biomed Industries, Inc.
Locations
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Coronavirus Research Institute
Sunnyvale, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NEUROSIVIR
Identifier Type: -
Identifier Source: org_study_id
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