Trials / Unknown
UnknownNCT04480333
Safety, Tolerability and Pharmacokinetics of Inhaled Nanoparticle Formulation of Remdesivir (GS-5734) and NA-831
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
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- Sponsor
- Biomed Industries, Inc. · Industry
- Sex
- All
- Age
- 21 Years – 50 Years
- Healthy volunteers
- Not accepted
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.
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
- Neurodegeneration
- Neuroinflammatory Response
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Drug: NA-831 - 0.10 mg/kg | NA-831 in nanoparticle inhalation formulation |
| DRUG | Placebo- 0.10 mg/kg | Placebo in nanoparticle inhalation formulation |
| DRUG | Drug: NA-831 - 0.20 mg/kg | NA-831 in nanoparticle inhalation formulation |
| DRUG | Placebo- 0.20 mg/kg | Placebo in nanoparticle inhalation formulation |
| DRUG | Drug: GS-5734 - 1.00 mg/kg | GS-5734 in nanoparticle inhaled formulation |
| DRUG | Placebo- 1.00 mg/kg | Placebo in nanoparticle inhalation formulation |
| DRUG | Drug: GS-5734 - 2.00 mg/kg | GS-5734 in nanoparticle inhaled formulation |
| DRUG | Placebo- 2.00 mg/kg | Placebo in nanoparticle inhaled formulation |
| COMBINATION_PRODUCT | 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 |
| COMBINATION_PRODUCT | Placebo 0.10 mg + 1.00 mg/kg | The combined placebo are in nanoparticle inhaled formulation |
| COMBINATION_PRODUCT | 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 |
| COMBINATION_PRODUCT | Placebo 0.20 mg + 2.00 mg/kg | Placebo 0.10 mg + 1.00 mg/kg |
Timeline
- Start date
- 2020-09-15
- Primary completion
- 2020-12-31
- Completion
- 2021-03-31
- First posted
- 2020-07-21
- Last updated
- 2020-07-21
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04480333. Inclusion in this directory is not an endorsement.