Safety, Tolerability and Pharmacokinetics of Inhaled Nanoparticle Formulation of Remdesivir (GS-5734) and NA-831
Public ClinicalTrials.gov record NCT04480333. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04480333
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 45 participants
Conditions and interventions
Conditions
Interventions
- Drug: NA-831 - 0.10 mg/kg Drug
- Placebo- 0.10 mg/kg Drug
- Drug: NA-831 - 0.20 mg/kg Drug
- Placebo- 0.20 mg/kg Drug
- Drug: GS-5734 - 1.00 mg/kg Drug
- Placebo- 1.00 mg/kg Drug
- Drug: GS-5734 - 2.00 mg/kg Drug
- Placebo- 2.00 mg/kg Drug
- Drugs: NA-831 (0.10 mg/kg) plus GS-5734 (1.00 mg/kg) Combination Product
- Placebo 0.10 mg + 1.00 mg/kg Combination Product
- Drugs: NA-831 (0.20 mg/kg) plus GS-5734 (2.00 mg/kg) Combination Product
- Placebo 0.20 mg + 2.00 mg/kg Combination Product
Drug · Combination Product
Eligibility (public fields only)
- Age range
- 21 Years to 50 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 14, 2020
- Primary completion
- Dec 30, 2020
- Completion
- Mar 30, 2021
- Last update posted
- Jul 20, 2020
2020 – 2021
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Coronavirus Research Institute | Sunnyvale | California | 94086 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04480333, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 20, 2020 · Synced Sep 3, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04480333 live on ClinicalTrials.gov.