Phase 1 Clinical Trial of a Q GRFT Nasal Spray
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of Participants With Related Grade 2 or Higher Adverse Events
研究概览
简要总结
This is a phase I randomized, placebo-controlled, single site to assess the local and systemic safety of intranasal Q-Griffithsin (Q-GRFT) after 14 doses in approximately 45 adult participants. Participants will be randomized 2:1 (Q-GRFT nasal spray: placebo nasal spray) resulting in 30 participants enrolled into the Q-GRFT arm and 15 participants enrolled into the placebo arm. A clinician will apply two metered doses of Q-GRFT in each nostril (400μl total) of the participant on the day of enrollment. Participants will be monitored in the clinic for 1 hour after administration and return for a 24-hour post dose visit. If safe and acceptable, a second period of daily administration by the participant for 13 days will commence. Safety assessments will be performed at day 7, day 14, and day 28 visits after the initiation of the second period. The expected duration of study participation for each participant will be approximately 6-8 weeks. The primary endpoint is the proportion of participants who experience a related Grade 2 or higher adverse event. Secondary and exploratory endpoints include persistence and systemic absorption of Q-GRFT, acceptability and the impact of Q-GRFT nasal spray on smell.
详细描述
This is a phase 1 study for intranasal application of Q-Griffithsin (Q-GRFT) spray as a prophylactic for severe acute respiratory syndrome-CoV-2. This randomized, placebo-controlled, single site will assess the local and systemic safety of intranasal Q-GRFT after 14 doses in approximately 45 adult participants. Participants will be randomized 2:1 (Q-GRFT nasal spray: placebo nasal spray) resulting in 30 participants enrolled into the Q-GRFT arm and 15 participants enrolled into the placebo arm. Accrual of approximately 45 evaluable participants is expected to take 6 months. The expected duration of study participation for each participant will be approximately 6-8 weeks. A clinician will apply two metered doses of Q-GRFT in each nostril (400μl total) of the participant on the day of enrollment. Participants will be monitored in the clinic for 1 hour after administration and return for a 24-hour post dose visit. If safe and acceptable, a second period of daily administration by the participant for 13 days will commence after a 5-49 day washout period. Safety assessments will be performed at day 7, day 14, and day 28 visits after the initiation of the second period. Additional safety assessments will be done by contacting participants between the 24-hour and 7-day visits and 7- and 14-day visits. The expected duration of study participation for each participant will be approximately 6-8 weeks. The primary endpoint is the proportion of participants who experience a related Grade 2 or higher adverse event. Secondary and exploratory endpoints include persistence and systemic absorption of Q-GRFT, acceptability and the impact of Q-GRFT nasal spray on smell.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to provide written informed consent
- •In general good health as determined by the site clinician
- •Negative SARS-CoV-2 test at screening
- •Fully vaccinated for SARS-CoV-2 (does not include booster vaccination)
- •Agree to abstain from any other investigational drug studies for the duration of the study
- •Agree to abstain from nasally administered products, including over-the-counter products, for the duration of the study
- •Report use of an effective method of contraception at enrollment and intending to continue use of an effective method for the duration of study participation. Acceptable methods include:
- •Males: Male condoms, sterilization of participant or partner, partner use of hormonal contraception or intrauterine device, identifies as a man who has sex with men exclusively, and/or sexually abstinent for the past 60 days and agrees to remain abstinent for the study duration
- •Females: Hormonal methods at the time of enrollment, intrauterine device inserted prior to enrollment, sterilization of participant or partner, consistent condom use of male partner for at least 28 days (reports using condoms 10 times in the last 10 acts of intercourse), identifies as a woman who has sex with women exclusively, and/or sexually abstinent for the past 60 days and agrees to remain abstinent for the study duration.
- •Agree to participate in all study-related assessments and procedures
排除标准
- •Abnormal nasal or throat exam at enrollment
- •If female, pregnancy, or within 42 days of last pregnancy at screening
- •If female, breastfeeding
- •Diagnosed with SARS-CoV-2 in the past 42 days at screening
- •Diagnosed or suspected respiratory tract infection in the past 14 days at screening (including asymptomatic SARS-CoV-2)
- •Participation in an investigational drug study in past 30 days at screening
- •Any condition that, in the opinion of the Investigator would preclude provision of consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
- •Use of any intranasal product in the 14 days prior to enrollment
- •Surgical procedure involving the nose or throat 90 days prior to enrollment
- •Any of the following laboratory abnormalities at screening:
- •Hgb < 12g/dL (men) and < 11g/dL (women)
- •Serum creatinine > 1.1 x upper limit of normal
- •alanine transaminase, aspartate aminotransferase, and total bilirubin > 1.1 x upper limit of normal
- •Grade 2 or higher seasonal allergies at the time of enrollment
- •Reported use of illicit drugs
- •Non-therapeutic injection drug use in the 12 months prior to screening
- •Any use of methamphetamine, gamma hydroxybutyrate, cocaine or heroin in the 12 months prior to screening
- •Use of systemic prescription immunomodulatory medications within the 4 weeks prior to the enrollment
研究组 & 干预措施
Q-GRFT Nasal Spray
Q-Griffithsin (Q-GRFT) nasal spray (7.5mg/mL). Two metered doses of 100μL into each nostril, total of 3mg Q-GRFT per administration, administered once daily for 14 consecutive days.
干预措施: Q-Griffithsin (Drug)
Placebo Nasal Spray
Placebo Nasal Spray. Two metered doses of 100μL into each nostril, administered once daily for 14 consecutive days.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Related Grade 2 or Higher Adverse Events
时间窗: Approximately 8 weeks
Number of participants with Grade 2 or higher adverse events deemed related to study product
次要结局
- Q-GRFT Plasma Concentration Collected at 24 Hours After 13 Consecutive Daily Intranasal Applications(24 hours after final dose of study product)
- Area Under the Plasma Concentration Versus Time Curve of Q-GRFT(Approximately 28 days)
- Q-GRFT Concentration From Nasopharyngeal Swab Eluent Collected at 24 Hours(Approximately 24 hours)
- Acceptability of the Intranasal Spray(Approximately 14 days)
研究者
Sharon Hillier
Professor
University of Pittsburgh