A Randomized, Triple-Blind, Placebo-Controlled Phase I Study of Single and Multiple Ascending Doses of NVG-291 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
This is a randomized, triple-blind (subjects, Investigators, and Sponsor blinded), placebo-controlled Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) study to evaluate the safety and tolerability of NVG-291 administered by subcutaneous injection daily in healthy female participants. The trial is split into three parts, starting with Part 1 (SAD), then Part 2 (MAD - post-menopausal Females), and finally Part 3 (MAD - males and premenopausal females). In Part 1 (SAD), participants receive 1 dose on 1 day only and in Parts 2 and 3, participants receive 1 dose every day for 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects between 18 and 65 years old.
- •BMI between 18 and 33 kg/m2, inclusive, and a total body weight > 50 kg.
- •All laboratory values must be within normal limits or any abnormalities deemed not clinically significant.
- •All subjects must be willing to abstain from sexual intercourse or to use adequate contraception during the study and for an additional 120 days after the follow-up visit.
- •Subjects must not donate ova or sperm during the study and for an additional 120 days after the follow-up visit
- •Subjects must be willing and able to comply with scheduled visits, all sample collections, and other trial procedures.
- •Subjects must provide written informed consent.
排除标准
- •For premenopausal female subjects: Irregular menstrual cycles; Amenorrhea; or Abnormal vaginal bleeding
- •A history (within the past year) or presence of a clinically significant infectious disease or hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, neurologic, or psychiatric abnormality.
- •Blood pressure > 160/95 at screening or on Day -
- •Any active or uncontrolled infections or other medical condition or circumstance that could interfere with the subject's participation in the study.
- •History of allergic reaction to mannitol.
- •Presence of a tattoo, piercing, scar, or other dermatologic abnormality at the injection site (abdomen), that might interfere with the ability to assess injection site reactions
- •a significant history of atopic dermatitis as an adult, or history of severe allergic reaction to injections.
- •INR > 1.4 or PTT > 50 or platelets <50x10^3/µL at screening or on Day -
- •History of regular alcohol consumption exceeding 10 units/week (1 unit = 83 mL of 12% wine) within 6 months of screening.
- •Test positive for use of drugs or alcohol at screening.
- •Positive hepatitis B, hepatitis C, or HIV test at screening.
- •Blood or plasma donation within 1 week prior to Day -
- •Receipt of an investigational drug within 30 days or five half-lives of the drug (whichever is longer) prior to Day -
- •Prior participation in this trial.
- •Female subjects who are breastfeeding or who have a positive pregnancy test at screening or Day -
- •History of any condition that might impair the subject's ability to understand or to comply with the requirements of the study or to provide informed consent.
- •Receipt of a COVID-19 vaccination within 3 weeks prior to Day -1
- •Subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior or endorsing items 4 or 5 on the Columbia-Suicide Severity Rating Scale at screening
研究组 & 干预措施
NVG-291 SAD
Doses will begin at the lowest dose level in Cohort 1, increasing in dose with each subsequent cohort to the highest dose level in Cohort 6 or until a maximum tolerated dose (MTD) is reached.
干预措施: NVG-291 (Drug)
NVG-291 SAD
Doses will begin at the lowest dose level in Cohort 1, increasing in dose with each subsequent cohort to the highest dose level in Cohort 6 or until a maximum tolerated dose (MTD) is reached.
干预措施: Placebo (Other)
NVG-291 MAD
Participants will receive 1 dose daily for for 14 consecutive days. The maximum starting dose for MAD will be 2 dose levels lower than the maximum dose achieved during SAD. There will be a maximum of 3 dosing cohorts in Part 2. The maximum daily dose in Part 2 will not exceed the maximum daily dose tolerated in Part 1.
干预措施: NVG-291 (Drug)
NVG-291 MAD
Participants will receive 1 dose daily for for 14 consecutive days. The maximum starting dose for MAD will be 2 dose levels lower than the maximum dose achieved during SAD. There will be a maximum of 3 dosing cohorts in Part 2. The maximum daily dose in Part 2 will not exceed the maximum daily dose tolerated in Part 1.
干预措施: Placebo (Other)
NVG-291 MAD - Males and Premenopausal Females
Participants will receive 1 dose daily for for 14 consecutive days. The dose maximum daily dose in Part 3 will not exceed the maximum daily dose tolerated in either Part 1 or 2.
干预措施: NVG-291 (Drug)
NVG-291 MAD - Males and Premenopausal Females
Participants will receive 1 dose daily for for 14 consecutive days. The dose maximum daily dose in Part 3 will not exceed the maximum daily dose tolerated in either Part 1 or 2.
干预措施: Placebo (Other)
结局指标
主要结局
Adverse Events
时间窗: Assessed through 7 days following the last dose of study drug
number and frequency of adverse events
次要结局
- Immunogenicity analysis(Assessed on Day 1 (SAD and MAD), Day 8 (SAD and MAD) and Day 21 (MAD only))
- Pharmacokinetic analysis (plasma)(Assessed on Day 1 (SAD and MAD) and Day 14 (MAD only))