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Virus Therapy
Safety, Tolerability, and Pharmacokinetics of Q-Griffithsin Intranasal Spray
Phase 1
Waitlist Available
Led By Gerald W Dryden, MD, PhD
Research Sponsored by Kenneth Palmer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 0, 6 or 7 (day 9)
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a special nasal spray called Q-GRFT in healthy volunteers. The spray is designed to prevent COVID-19 and other coronaviruses by blocking them in the nose. The study aims to ensure the spray is safe for use.
Eligible Conditions
- Coronavirus Prevention
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ visit 0, 6 or 7 (day 9)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 0, 6 or 7 (day 9)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety of product by measuring number of subjects that experience Adverse Events greater than Grade 3.
Secondary study objectives
Acceptability
Anti-drug antibody levels
Pharmacokinetic levels
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Q-Griffithsin Group 2: two 3.0 mg sprays per dayExperimental Treatment1 Intervention
In Group 2, up to 12 participants will be enrolled to receive a total of 6.0 mg intranasal Q-GRFT administered as 3.0 mg twice daily (3.0 mg BID), with 2 sprays (100 µL/ spray) in each nostril approximately every 12 hours, for 7 days.
Group II: Q-Griffithsin Group 1: 3.0 mg daily sprayExperimental Treatment1 Intervention
In Group 1, up to 12 participants will receive a dose of 3.0 mg intranasal Q-GRFT administered once daily, as 2 sprays (100 µL/ spray) in each nostril, for 7 days.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Kenneth PalmerLead Sponsor
1 Previous Clinical Trials
18 Total Patients Enrolled
United States Department of DefenseFED
913 Previous Clinical Trials
334,282 Total Patients Enrolled
Gerald W Dryden, MD, PhDPrincipal InvestigatorUniversity of Louisville