Clinical Trial to Evaluate the Safety of RQ-01 in SARS-CoV-2 Positive Subjects

Summary

This is a first in human clinical study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of RQ-01. Adult patients who have tested positive for SARS-CoV-2 virus, have mild symptom(s) of COVID-19 disease, and who are at low risk for developing moderate or severe COVID-19 disease are welcome to participate. The main questions this study aims to answer are:

1. What is the safety profile of RQ-01?
2. What is the reduction in SARS-CoV-2 ribonucleic acid (RNA) shedding after administration of RQ-01?
3. How effective is RQ-01 versus placebo in reducing COVID-19 symptoms?

After providing informed consent, subjects will be randomized to RQ-01 (high or low dose) or placebo and will be dosed for 3 consecutive days. Throughout the duration of the trial, subjects will participate in the following activities: perform rapid antigen and polymerase chain reaction (PCR) tests for COVID-19, answer questions about their medical history and medications, answer questions about their COVID-19 history and symptoms, conduct a physical exam, have their vitals measured, and have bloodwork done.

Conditions

• COVID-19
• Infectious Disease
• Symptomatic COVID-19 Infection Laboratory-Confirmed
• SARS CoV 2 Infection

Interventions

COMBINATION_PRODUCT

RQ-001

Drug product RQ-001 is the fully assembled device consisting of the vial containing RQ-01 and the actuator. Drug Product RQ-001 has been developed with an Aptar Bidose liquid nasal spray unit device (BDSI V3) capable of intranasally delivering a 200 uL total volume of drug product (specifically, 100 uL per nare, which delivers a 200 uL of total volume). The combination product comprises the drug constituent (RQ-01) and the assembly of commercially available, off-the-shelf device components. Study staff will be responsible for assembling the drug product RQ-001 and subjects will self-administer under the supervision of study staff in the clinic.

OTHER

Placebo

Matching placebo will be manufactured just as RQ-01 drug substance, with the active ingredient addition step omitted. Placebo will appear similar to RQ-01 drug substance as a clear to hazy, colorless to yellowish liquid. Matching placebo will be administered the same way as RQ-01

Sponsors & Collaborators

• PPD Development, LP

  collaborator INDUSTRY

• Red Queen Therapeutics, Inc.

  lead INDUSTRY

Principal Investigators

• Paul Eisenberg, MD, MPH · Red Queen Therapeutics

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-27

Primary Completion

2024-01-03

Completion

2024-01-03

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations