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Safety, Tolerability, and Pharmacokinetics of Q-Griffithsin Intranasal Spray

NCT05437029 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-07-05

No results posted yet for this study

Summary

The purpose of this study is to test the safety of multiple doses of a Q-GRFT nasal spray in healthy volunteers. This Q-GRFT nasal spray is "investigational and not approved by the FDA for general use" and is being developed to prevent the transmission of COVID-19 and other coronaviruses.

Conditions

  • COVID-19 Prevention

Interventions

DRUG

Q-Griffithsin 3.0

This is an open-label dose-escalation study to assess the safety, tolerability, and pharmacokinetics (PK) of a multiple dosing schedule of low dose Q GRFT intranasal spray DP

DRUG

Q-Griffithsin 6.0

This is an open-label dose-escalation study to assess the safety, tolerability, and pharmacokinetics (PK) of a multiple dosing schedule of high dose Q GRFT intranasal spray DP

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Kenneth Palmer

    lead OTHER

Principal Investigators

  • Gerald W Dryden, MD, PhD · University of Louisville

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-15
Primary Completion
2022-10-15
Completion
2022-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05437029 on ClinicalTrials.gov