Covid19Phase 1NEUROSIVIRNCT04480333
Safety, Tolerability and Pharmacokinetics of Inhaled Nanoparticle Formulation of Remdesivir (GS-5734) and NA-831
A Phase 1 study testing Drug: NA-831 - 0.10 mg/kg, Drug: NA-831 - 0.20 mg/kg and Drug: GS-5734 - 1.00 mg/kg in people with Covid19 and Corona Virus Infection, run by Biomed Industries, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Covid19, Corona Virus Infection, Severe Acute Respiratory Syndrome
- What is being tested?
- Drug: NA-831 - 0.10 mg/kg, Drug: NA-831 - 0.20 mg/kg and Drug: GS-5734 - 1.00 mg/kg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2020to 31 Mar 2021
- 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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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-Barré syndrome [genetic/congenital or acquired]).
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- 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.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Coronavirus Research Institute
Sunnyvale, California, 94086
David Nguyen, MD, research@covri.org
Lloyd Tran, PhD, LTran@neuroactiva.com
About this study
Official title: A Randomized, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Inhaled Nanoparticle Formulation of Remdesivir (GS-5734) and in Combination With NA-831 in Healthy Volunteers
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.
Read the detailed 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 SARS-CoV and MERS-CoV.
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
- Covid19, Corona Virus Infection, Severe Acute Respiratory Syndrome, Severe Acute Respiratory Infection, Severe Acute Respiratory Syndrome (SARS) Pneumonia, Severe Acute Respiratory Syndrome of Upper Respiratory Tract
- Being tested
- 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
- Keywords
- Covid-19, Corona Virus Infection, Severe Acute Respiratory Syndrome, Severe Acute Respiratory Infection, Severe Acute Respiratory Syndrome (SARS) Pneumonia, Severe Acute Respiratory Syndrome of Upper Respiratory Tract, Neurodegeneration, Neuroinflammation, Cognitive decline
- Medical subject headings
- COVID-19, Coronavirus Infections, Severe Acute Respiratory Syndrome, Pneumonia, Nerve Degeneration, Neuroinflammatory Diseases, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: NA-831 - 0.10 mg/kgDrug
Also called NA-831 is a neuroprotective and neurogenesis drug
NA-831 in nanoparticle inhalation formulation
Placebo- 0.10 mg/kgDrug
Also called Placebo Comparator
Placebo in nanoparticle inhalation formulation
Drug: NA-831 - 0.20 mg/kgDrug
Also called NA-81 is a neuroprotective drug
NA-831 in nanoparticle inhalation formulation
Placebo- 0.20 mg/kgDrug
Also called Placebo Comparator
Placebo in nanoparticle inhalation formulation
Drug: GS-5734 - 1.00 mg/kgDrug
Also called GS-5734 (Remdesivir) is an antiviral drug
GS-5734 in nanoparticle inhaled formulation
Placebo- 1.00 mg/kgDrug
Also called Placebo Comparator
Placebo in nanoparticle inhalation formulation
Drug: GS-5734 - 2.00 mg/kgDrug
Also called GS-5734 (Remdesivir) is an anti-viral drug
GS-5734 in nanoparticle inhaled formulation
Placebo- 2.00 mg/kgDrug
Also called Placebo Comparator
Placebo in nanoparticle inhaled formulation
Drugs: NA-831 (0.10 mg/kg) plus GS-5734 (1.00 mg/kg)Combination product
Also called Combination therapy of NA-831 a neuroprotective drug and GS-5734 an antiviral drug
The combined NA-831 and GS-5734 are in nanoparticle inhaled formulation
Placebo 0.10 mg + 1.00 mg/kgCombination product
Also called Placebo Comparator
The combined placebo are in nanoparticle inhaled formulation
Drugs: NA-831 (0.20 mg/kg) plus GS-5734 (2.00 mg/kg)Combination product
Also called Combination therapy of NA-831, a neuroprotective drug and GS-5734, an antiviral drug
The combined NA-831 and GS-5734 are in nanoparticle inhaled formulation
Placebo 0.20 mg + 2.00 mg/kgCombination product
Also called Placebo Comparator
Placebo 0.10 mg + 1.00 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Drug: NA-831 - 0.10 mg/kg | Experimental | 3 Subjects will take inhaled formulation of NA-831 once a day for 5 days Receives: Drug: Drug: NA-831 - 0.10 mg/kg |
| Comparable Placebo- 0.10 mg/kg | Placebo comparator | 3 subjects will take inhaled formulation of placebo once a day for 5 days Receives: Drug: Placebo- 0.10 mg/kg |
| Drug: NA-831 - 0.20 mg/kg | Experimental | 6 Subjects will take inhaled formulation of NA-831 once a day for 5 days Receives: Drug: Drug: NA-831 - 0.20 mg/kg |
| Comparable Placebo- 0.20 mg/kg | Placebo comparator | 3 subjects will take inhaled formulation of placebo once a day for 5 days Receives: Drug: Placebo- 0.20 mg/kg |
| Drug: GS-5734 - 1.00 mg/kg | Experimental | 3 Subjects will take inhaled formulation of GS-5734 once a day for 5 days Receives: Drug: Drug: GS-5734 - 1.00 mg/kg |
| Comparable Placebo- 1.00 mg.kg | Placebo comparator | 3 Subjects will take inhaled formulation of GS-5734 once a day for 5 days Receives: Drug: Placebo- 1.00 mg/kg |
| Drug: GS-5734 - 2.00 mg/kg | Experimental | 6 Subjects will take inhaled formulation of GS-5734 once a day for 5 days Receives: Drug: Drug: GS-5734 - 2.00 mg/kg |
| Comparable Placebo - 2.00 mg/kg | Placebo comparator | 3 Subjects will take inhaled formulation of GS-5734 once a day for 5 days Receives: Drug: Placebo- 2.00 mg/kg |
| Drugs: NA-831 (0.10 mg/kg) plus GS-5734 (1.00 mg/kg) | Experimental | 3 Subjects- will take inhaled formulation NA-831 (0.10 mg/kg) plus GS-5734 (1.00 mg/kg) once/day for 5 days Receives: Combination Product: Drugs: NA-831 (0.10 mg/kg) plus GS-5734 (1.00 mg/kg) |
| Placebo- 0.10- mg/kg placebo+1.00 mg mg/kg | Placebo comparator | 3 Subjects - inhaled formulation of placebo once/day for 5 days Receives: Combination Product: Placebo 0.10 mg + 1.00 mg/kg |
| Drugs: NA-831( 0.20 mg/kg) + GS-5734 (2.00 mg/kg) | Experimental | 6 Subjects- inhaled formulation of NA-831 (0.20 mg/kg) + GS-5734 (2.00 mg/kg) once/day for 5 days Receives: Combination Product: Drugs: NA-831 (0.20 mg/kg) plus GS-5734 (2.00 mg/kg) |
| Placebo- 0.20 mg/kg + 2.00mg/kg | Placebo comparator | 3 Subjects- inhaled formulation of placebo once/day for 5 days Receives: Combination Product: Placebo 0.20 mg + 2.00 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Experiencing any Treatment-Emergent Adverse Events
AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Measured: First dose date up to Day 30 Follow-up Assessment
Proportion of Participants Experiencing any Treatment-Emergent Graded Laboratory Abnormalities
This will be assessed at various time points by clinical laboratory tests and vital signs.
Measured: First dose date up to Day 30 Follow-up Assessment
Secondary outcomes (7)
Maximum Concentration (Cmax) - Pharmacokinetic Assessment
Monitoring of the levels of drugs in subject sera at various time points to elucidate the maximum concentration (Cmax) of NA-831 and GS-5734 in human serum.
Measured: 7 days
Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment
Monitoring of the levels of drugs in subject sera at various time points to elucidate the time to maximum concentration (Tmax) of NA-831 and GS-5734 in human serum
Measured: 7 days
AUC calculated from time of administration to the last measurable concentration (AUC0-last) - Pharmacokinetic Assessment
Monitoring of the levels of drugs in subject sera at various time points to elucidate the area under the curve from time of administration to the last measurable of NA-831 and GS-5734
Measured: 7 days
Area Under the Curve Extrapolated to Infinity (AUC0-∞)
Monitoring of the levels of drugs in subject sera at various time points to elucidate the area under the curve extrapolated to infinity (AUC0-∞) of NA-831 and GS-5734
Measured: 7 days
Half-Life (t1/2) - Pharmacokinetic Assessment
Monitoring of the levels of drugs in subject sera at various time points to elucidate the half-life (t1/2) of NA-831 and GS-5734 in human serum.
Measured: 7 days
Volume of Distribution (Vd) - Pharmacokinetic Assessment
Monitoring of the levels of drugs in subject sera through various time points to elucidate the volume of distribution (Vd) of NA-831 and GS-5734 in human serum.
Measured: 7 days
Clearance [CL] - Pharmacokinetic Assessment
Monitoring of the levels of drugs in subject sera through at various time points to elucidate clearance [CL] of NA-831 and GS-5734 in human serum.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start15 Sep 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Crossover
- Model description
- The dose escalation given to healthy volunteers across the following cohorts: 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biomed Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lloyd Tran, PhD, Study director, Biomed Industries, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480333
- Sponsor's protocol ID
- NEUROSIVIR
- Acronym
- NEUROSIVIR
- Status last verified
- Jul 2020
- First submitted
- 13 Jul 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share the Study Protocol
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Inhaled Nanoparticle Formulation of Remdesivir (GS-5734) and in Combination With NA-831 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04480333
- Acronym / sponsor ID
- NEUROSIVIR / NEUROSIVIR
- Conditions
- Covid19, Corona Virus Infection, Severe Acute Respiratory Syndrome, Severe Acute Respiratory Infection, Severe Acute Respiratory Syndrome (SARS) Pneumonia, Severe Acute Respiratory Syndrome of Upper Respiratory Tract
- Keywords
- Covid-19, Corona Virus Infection, Severe Acute Respiratory Syndrome, Severe Acute Respiratory Infection, Severe Acute Respiratory Syndrome (SARS) Pneumonia, Severe Acute Respiratory Syndrome of Upper Respiratory Tract, Neurodegeneration, Neuroinflammation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Biomed Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 21 Jul 2020 (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.
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.
Detailed 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 SARS-CoV and MERS-CoV.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 12
- Model description
- The dose escalation given to healthy volunteers across the following cohorts: 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.
| Arm | Type | Receives |
|---|---|---|
| Drug: NA-831 - 0.10 mg/kg | Experimental | Drug: Drug: NA-831 - 0.10 mg/kg3 Subjects will take inhaled formulation of NA-831 once a day for 5 days |
| Comparable Placebo- 0.10 mg/kg | Placebo comparator | Drug: Placebo- 0.10 mg/kg3 subjects will take inhaled formulation of placebo once a day for 5 days |
| Drug: NA-831 - 0.20 mg/kg | Experimental | Drug: Drug: NA-831 - 0.20 mg/kg6 Subjects will take inhaled formulation of NA-831 once a day for 5 days |
| Comparable Placebo- 0.20 mg/kg | Placebo comparator | Drug: Placebo- 0.20 mg/kg3 subjects will take inhaled formulation of placebo once a day for 5 days |
| Drug: GS-5734 - 1.00 mg/kg | Experimental | Drug: Drug: GS-5734 - 1.00 mg/kg3 Subjects will take inhaled formulation of GS-5734 once a day for 5 days |
| Comparable Placebo- 1.00 mg.kg | Placebo comparator | Drug: Placebo- 1.00 mg/kg3 Subjects will take inhaled formulation of GS-5734 once a day for 5 days |
| Drug: GS-5734 - 2.00 mg/kg | Experimental | Drug: Drug: GS-5734 - 2.00 mg/kg6 Subjects will take inhaled formulation of GS-5734 once a day for 5 days |
| Comparable Placebo - 2.00 mg/kg | Placebo comparator | Drug: Placebo- 2.00 mg/kg3 Subjects will take inhaled formulation of GS-5734 once a day for 5 days |
| Drugs: NA-831 (0.10 mg/kg) plus GS-5734 (1.00 mg/kg) | Experimental | Combination Product: 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 |
| Placebo- 0.10- mg/kg placebo+1.00 mg mg/kg | Placebo comparator | Combination Product: Placebo 0.10 mg + 1.00 mg/kg3 Subjects - inhaled formulation of placebo once/day for 5 days |
| Drugs: NA-831( 0.20 mg/kg) + GS-5734 (2.00 mg/kg) | Experimental | Combination Product: Drugs: NA-831 (0.20 mg/kg) plus 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 |
| Placebo- 0.20 mg/kg + 2.00mg/kg | Placebo comparator | Combination Product: Placebo 0.20 mg + 2.00 mg/kg3 Subjects- inhaled formulation of placebo once/day for 5 days |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
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 |
|---|---|---|
| Drug: NA-831 - 0.10 mg/kgAlso: NA-831 is a neuroprotective and neurogenesis drugNA-831 in nanoparticle inhalation formulation | Drug | Drug: NA-831 - 0.10 mg/kg |
| Placebo- 0.10 mg/kgAlso: Placebo ComparatorPlacebo in nanoparticle inhalation formulation | Drug | Comparable Placebo- 0.10 mg/kg |
| Drug: NA-831 - 0.20 mg/kgAlso: NA-81 is a neuroprotective drugNA-831 in nanoparticle inhalation formulation | Drug | Drug: NA-831 - 0.20 mg/kg |
| Placebo- 0.20 mg/kgAlso: Placebo ComparatorPlacebo in nanoparticle inhalation formulation | Drug | Comparable Placebo- 0.20 mg/kg |
| Drug: GS-5734 - 1.00 mg/kgAlso: GS-5734 (Remdesivir) is an antiviral drugGS-5734 in nanoparticle inhaled formulation | Drug | Drug: GS-5734 - 1.00 mg/kg |
| Placebo- 1.00 mg/kgAlso: Placebo ComparatorPlacebo in nanoparticle inhalation formulation | Drug | Comparable Placebo- 1.00 mg.kg |
| Drug: GS-5734 - 2.00 mg/kgAlso: GS-5734 (Remdesivir) is an anti-viral drugGS-5734 in nanoparticle inhaled formulation | Drug | Drug: GS-5734 - 2.00 mg/kg |
| Placebo- 2.00 mg/kgAlso: Placebo ComparatorPlacebo in nanoparticle inhaled formulation | Drug | Comparable Placebo - 2.00 mg/kg |
| Drugs: NA-831 (0.10 mg/kg) plus GS-5734 (1.00 mg/kg)Also: Combination therapy of NA-831 a neuroprotective drug and GS-5734 an antiviral drugThe combined NA-831 and GS-5734 are in nanoparticle inhaled formulation | Combination product | Drugs: NA-831 (0.10 mg/kg) plus GS-5734 (1.00 mg/kg) |
| Placebo 0.10 mg + 1.00 mg/kgAlso: Placebo ComparatorThe combined placebo are in nanoparticle inhaled formulation | Combination product | Placebo- 0.10- mg/kg placebo+1.00 mg mg/kg |
| Drugs: NA-831 (0.20 mg/kg) plus GS-5734 (2.00 mg/kg)Also: Combination therapy of NA-831, a neuroprotective drug and GS-5734, an antiviral drugThe combined NA-831 and GS-5734 are in nanoparticle inhaled formulation | Combination product | Drugs: NA-831( 0.20 mg/kg) + GS-5734 (2.00 mg/kg) |
| Placebo 0.20 mg + 2.00 mg/kgAlso: Placebo ComparatorPlacebo 0.10 mg + 1.00 mg/kg | Combination product | Placebo- 0.20 mg/kg + 2.00mg/kg |
Primary outcome
Proportion of Participants Experiencing any Treatment-Emergent Adverse Events
Time frame: First dose date up to Day 30 Follow-up Assessment
AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Proportion of Participants Experiencing any Treatment-Emergent Graded Laboratory Abnormalities
Time frame: First dose date up to Day 30 Follow-up Assessment
This will be assessed at various time points by clinical laboratory tests and vital signs.
7 secondary outcomes
Maximum Concentration (Cmax) - Pharmacokinetic Assessment
Time frame: 7 days
Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment
Time frame: 7 days
AUC calculated from time of administration to the last measurable concentration (AUC0-last) - Pharmacokinetic Assessment
Time frame: 7 days
Area Under the Curve Extrapolated to Infinity (AUC0-∞)
Time frame: 7 days
Half-Life (t1/2) - Pharmacokinetic Assessment
Time frame: 7 days
Volume of Distribution (Vd) - Pharmacokinetic Assessment
Time frame: 7 days
Clearance [CL] - Pharmacokinetic Assessment
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Individual participant dataSharing planned: Yes. We plan to share the Study Protocol
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Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Lloyd Tran, PhD study director
Biomed Industries, Inc.
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 Drug: NA-831 - 0.10 mg/kg, Drug: NA-831 - 0.20 mg/kg and Drug: GS-5734 - 1.00 mg/kg in people with Covid19 and Corona Virus Infection, run by Biomed Industries, Inc. at 1 site in United States.
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 9 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: status not confirmed, as of the sponsor's last update on 21 Jul 2020. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brian Tran, MD (1-415-941-3133, BTran@neuroactiva.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Experiencing any Treatment-Emergent Adverse Events (time frame: First dose date up to Day 30 Follow-up Assessment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2020.