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

NCT05437029 | Unknown Phase 1 FDA Drug

• 2 other identifiers: 22.0224MCDC2006-010
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

COVID-19; Q-griffithsin; Nasal Spray; Prophylactic; Corona Virus; SARs CoV 2

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic levels

  Q-GRFT Study Product (SP) concentration will be assessed in nasopharyngeal fluids.

  Nasopharyngeal fluids on days 1, 2, 4, 7, 8, 9 for group 1; Days 2, 3, 5, 8, 9 for group 2

• Safety of product by measuring number of subjects that experience Adverse Events greater than Grade 3.

  Incidence of AEs Grade 3 or higher as defined by the Division of AIDS (DAIDS) Table or Grading the Severity of Adult and Pediatric Adverse Events, V2.1 (July 2017).

  3-4 weeks

Secondary Outcomes (5)

• Smell Assessment by Brief Smell Identification Test

  Visit 0, 6 or 7 (Day 9)

• Acceptability

  3 - 4 weeks

• Quality of life outcome

  Visit 0, 6 or 7 (Day 9)

• Anti-drug antibody levels

  Day 8 or 9

• Pharmacokinetic levels

  3 - 4 weeks

Study Arms (2)

Q-Griffithsin Group 1: 3.0 mg daily spray

EXPERIMENTAL

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.

Drug: Q-Griffithsin 3.0

Q-Griffithsin Group 2: two 3.0 mg sprays per day

EXPERIMENTAL

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.

Drug: Q-Griffithsin 6.0

Interventions

Q-Griffithsin 3.0 DRUG

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

Also known as: Q-Griffithsin Group 1

Q-Griffithsin Group 1: 3.0 mg daily spray

Q-Griffithsin 6.0 DRUG

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

Also known as: Q-Griffithsin Group 2

Q-Griffithsin Group 2: two 3.0 mg sprays per day

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Ongoing common cold or flu-like symptoms for 48 hours prior to the screening, including sore throat, blocked nose, runny nose, cough, and sneezing.
• 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).
• 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.
• Participants who are current smokers.
• Known allergy to methylparaben, or propylparaben, or any ingredients of the formulated drug product.
• 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.
• History of alcohol/ substance abuse within 6 months of study enrollment.
• History of any vaccinations within the 2 weeks prior to enrollment.
• Participating in another research study involving drugs or medical devices within the 4 weeks prior to enrollment.
• 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:
• White blood cell count \< 2,000 cells/mm3 or \> 15,000 cells/mm3.
• Hemoglobin \<12 g/dL for men and \<11 g/dL for women.

Sponsors & Collaborators

• Kenneth Palmer: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Louisville Clinical Trials Unit

Louisville, Kentucky, 40202, United States

RECRUITING

Related Publications (4)

• Doty RL, Marcus A, Lee WW. Development of the 12-item Cross-Cultural Smell Identification Test (CC-SIT). Laryngoscope. 1996 Mar;106(3 Pt 1):353-6. doi: 10.1097/00005537-199603000-00021.

  PMID: 8614203 BACKGROUND

• Chen H, Cisternas MG, Katz PP, Omachi TA, Trupin L, Yelin EH, Balmes JR, Blanc PD. Evaluating quality of life in patients with asthma and rhinitis: English adaptation of the rhinasthma questionnaire. Ann Allergy Asthma Immunol. 2011 Feb;106(2):110-118.e1. doi: 10.1016/j.anai.2010.10.027. Epub 2011 Jan 8.

  PMID: 21277512 BACKGROUND

• Doty RL. Office procedures for quantitative assessment of olfactory function. Am J Rhinol. 2007 Jul-Aug;21(4):460-73. doi: 10.2500/ajr.2007.21.3043.

  PMID: 17882917 BACKGROUND

• Cash E, Deitz K, Potts KL, Nabeta HW, Zahin M, Rai SN, Dryden GW, Palmer KE. Development and validation of a product acceptability questionnaire for intranasal Q-Griffithsin COVID-19 prophylaxis (SPRAY PAL). BMJ Open. 2023 Sep 12;13(9):e073735. doi: 10.1136/bmjopen-2023-073735.

  PMID: 37699630 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Gerald W Dryden, MD, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela Siegwald, RN

CONTACT

502-852-2043; angela.siegwald@louisville.edu

Amber Jackson

CONTACT

502-569-7904; Amber.Jackson.1@louisville.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: June 29, 2022
• Study Start: June 15, 2022
• Primary Completion: October 15, 2022
• Study Completion: November 1, 2022
• Last Updated: July 5, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)