A Phase 1b Study of a Q-Griffithsin Intranasal Spray for Broad-spectrum Coronavirus Prophylaxis

• Status: Recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kenneth Palmer
• Collaborator: United States Department of Defense

Criteria

Inclusion Criteria:

• COVID-19 negative using Rapid antigen test at screening.

• Able and willing to provide written informed consent to take part in the study.

• Able and willing to provide adequate information for locator purposes.

• Availability to return for all study visits, barring unforeseen circumstances.

• Agree not to participate in other research studies involving drugs and/or medical devices during the study period.

• Female participants must meet the following criteria:

Postmenopausal or using (or willing to use) an acceptable form of contraception (e.g., barrier method, IUD, hormonal contraception, sexual abstinence, surgical sterilization, or vasectomization of male partner).

If the female participant has female partners only, the method of contraception will be noted as a barrier method for study documentation.

Not be pregnant at the baseline or enrollment visit. Not be breastfeeding at screening or intend to breastfeed during study participation per participant report.

• Willingness and ability to defer vaccinations until after study participation is completed. This does not include COVID-19 vaccinations.

• Participants should have received all COVID-19 vaccines that they are eligible for. Those eligible for booster doses will not delay getting their dose for purposes of enrolling in the study. They will first obtain their booster dose and be re-evaluated for enrollment 2 weeks following their booster dose.

• Willingness to perform at-home study product self-administration according to written instructions that will be provided.

• Willingness to follow local guidelines for mask-wearing and face coverings.

• Must be in general good health in the opinion of the investigator.

Exclusion Criteria:

• Participants with ongoing moderate to severe allergic rhinitis, asthma, or history of chronic obstructive pulmonary disease (COPD), and currently suffering from chronic rhinitis or acute/chronic sinusitis.

• Participants who report any of the following at Screening:

1. Ongoing common cold or flu-like symptoms for 48 hours prior to the screening, including sore throat, blocked nose, runny nose, cough, and sneezing.

2. Participants who experience moderate or severe or higher seasonal allergies, such as hay fever, (symptoms in excess of mild, intermittent nasal rhinorrhea, sneezing, or itchy/watery eyes).

3. Non-therapeutic injection drug use in the 6 months prior to screening and recreational snorting drug use or on prescription medication/ concomitant therapy other than for contraception and antibiotics. Those excluded will include individuals taking prescription medications like systemic steroids, intranasal medicines, among others.

4. Participants who are current smokers.

5. Known allergy to methylparaben, or propylparaben, or any ingredients of the formulated drug product.

6. Use of systemic immunomodulatory medications (Thalidomide, Lenalidomide, Pomalidomide, Imiquimod, etc.), anticoagulants, and other drugs assessed by the site Investigator within the 4 weeks prior to study enrollment.

7. History of alcohol/ substance abuse within 6 months of study enrollment.

8. History of any vaccinations within the 2 weeks prior to enrollment.

9. Participating in another research study involving drugs or medical devices within the 4 weeks prior to enrollment.

10. Having plans to relocate away from the study site area during the period of study participation.

• Has any of the following laboratory abnormalities at Screening:

1. White blood cell count < 2,000 cells/mm3 or > 15,000 cells/mm3.

2. Hemoglobin <12 g/dL for men and <11 g/dL for women.

3. Calculated creatinine clearance >1.1 x upper limit of normal (ULN).

4. Alanine transaminase (ALT) and/or aspartate aminotransferase (AST) > 1.1 × the site laboratory ULN.

5. Total bilirubin > 1.1 x ULN.

6. ≥ +1 glucose or +2 protein on urinalysis (UA).

• Any other condition or prior therapy that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, make the individual unsuitable for the study, or unable to comply with the study requirements. Such conditions may include but are not limited to a current or recent history (within last 6 months) of severe, progressive, or uncontrolled substance abuse, or renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral disease, severe nasal septum deviation, or other condition that may cause nasal obstruction like nasal polyps or nasal/ sinus surgery in the past.