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

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.

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

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

Sponsors & Collaborators

• Biomed Industries, Inc.

  lead INDUSTRY

Principal Investigators

• Lloyd Tran, PhD · Biomed Industries, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-15

Primary Completion

2020-12-31

Completion

2021-03-31

FDA Drug

Yes

Countries

• United States

Study Locations