NCT05437029

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

A Phase 1b Study to Assess Safety, Tolerability, and Pharmacokinetics of a Multiple Dosing Schedule of Q-Griffithsin Intranasal Spray for Broad-spectrum Coronavirus Prophylaxis: A Study of the PREVENT-CoV Program

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Kenneth Palmer · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is an open-label dose-escalation study to assess the safety, tolerability, and pharmacokinetics (PK) of a multiple dosing schedule of Q GRFT intranasal spray DP. Up to 24 healthy participants will be enrolled and assigned to either of 2 groups to receive treatment. 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. The initial dose will be administered in the clinic by a study clinician. Participants will be taught how to self-administer the study product at the clinic and receive written instructions for at-home self-administration. Subsequent doses will be self-administered either at the clinic or at home. Group 1 participants will undergo PK sampling (nasal and nasopharyngeal fluids) at baseline (enrollment visit), on day 1 (1 hour, 6 hours, and 10 hours after the initial dose), day 2 (24±1 hours after initial dose), day 4 (pre-dose and 1-hour post-dose), day 7 (pre-dose, 1 hour, 6 hours, and 10 hours after the final dose, day 8 (24±1 hours) and day 9 (48±2 hours) following the final dose. Blood for evaluation of systemic exposure will be collected at baseline, day 1 and day 4 (1 hour post-dose), and on day 8, upon dose completion. 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. Administration of the third dose among Group 2 participants will be delayed to permit obtaining a 24-hour PK timepoint for one completed 6.0 mg BID treatment. The initial dose will be administered in the clinic by a study clinician. Participants will be taught to self-administer the study product at the clinic and receive written instructions for at-home self-administration. Subsequent doses will be self-administered either at the clinic or at home. Participants in this group will undergo PK sampling (nasal and nasopharyngeal fluids) at baseline (enrollment visit), on day 2 (1 hour, 6 hours, and 10 hours after the second dose), day 3 (24±1 hours after the second dose), day 5 (pre-dose after 3 completed doses of 6 mg and 1 hour post-dose), day 8 (pre-dose, 1 hour, 6 hours, and 10 hours after the final dose), day 9 (24±1 hours) and day 10 (48±2hours) following the final dose. Blood for evaluation of systemic exposure will be collected at baseline, on day 2 and day 5 (1 hour post-dose), and on day 9 after the final dose completion. Safety assessment for both groups will be conducted after 3 days of dosing, upon completion of the final dose, and within 3-4 weeks of dose completion. An optional rectal fluids sampling procedure using a sponge will be performed 1 day after the final dose, to assess for any study product in the gastrointestinal tract. Blood draws for anti-drug antibodies/ immunogenicity assays will be performed at baseline, 24±1 hours after the final dose and 3-4 weeks after the final dose administration. Additional participants will be enrolled in case any subjects do not complete all safety or primary PK assessments, in order to assure that a minimum of 9 subjects is available for full analysis. All sampling procedures will be performed in the clinic. This sample size is appropriate for a Phase 1b clinical study to gather additional multi-dosing safety data and preliminary PK data following completion of the single-dose treatment Phase 1a trial. The proposed studies will allow a careful selection of the ideal dose that will be administered to subjects in future Phase 2 studies.

Conditions

• COVID-19 Prevention

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-06-15
• Primary completion: 2022-10-15
• Completion: 2022-11-01
• First posted: 2022-06-29
• Last updated: 2022-07-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study