ISRCTN30841680已完成1 期
A Phase Ib, randomized, double-blind, placebo-controlled, single-center study to evaluate the safety and pharmacokinetics of multiple ascending doses of GDC-6988 with and without albuterol pretreatment in healthy adult subjects
F. Hoffman-La Roche Ltd.0 个研究点目标入组 41 人开始时间: 2022年8月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Signed Informed Consent Form
- •2. Age 18-55 years at time of signing Informed Consent Form
- •3. Ability to comply with the study protocol
- •4. Body mass index of 18-32 kg/m² at screening
- •5. Body temperature of 35-37.5 degrees C at screening and at Day -1
- •6. Systolic blood pressure of 90 - 150 mmHg and diastolic blood pressure of 50-95 mmHg at screening and at Day -1. Blood pressure should be measured while the subject is in a seated position
- •7. Agreement to abstain from consumption of caffeine-containing foods and beverages from 72 hours prior to clinic check-in and during the residential stay at the clinic
- •8. Agreement to abstain from consumption of alcohol from 24 hours prior to clinic check-in and during the residential stay at the clinic
- •9. FEV1 >80% of predicted at screening and at Day -1
- •10. Forced vital capacity (FVC) >2.0L by spirometry at screening
- •11. Ability to demonstrate correct use of the Smart DPI (with placebo capsules) at Screening
- •12. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, as defined below:
- •12.1. Women must remain abstinent or use contraceptive methods with a failure rate of <1% per year during treatment and for 28 days after the final dose of study drug
- •12.2. A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (=12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). Per this definition, a woman with a tubal ligation is considered to be of childbearing potential. The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.
- •12.3. Examples of contraceptive methods with a failure rate of <1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices
- •12.4. Hormonal contraceptive methods must be supplemented by a barrier method
- •12.5. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject
- •12.6. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception
- •12.7. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form
- •12.8. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below:
- •12.9. With a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during treatment and for 28 days after final dose of study drug to avoid exposing the embryo. Men must refrain from donating sperm during this same period
- •12.10. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of preventing d
排除标准
- •1. Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 28 days after the final dose of study drug. Women of childbearing potential must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result on Day -1.
- •2. Study site employee or immediate family member of a study site or Sponsor employee
- •3. Treatment with investigational therapy (or blinded comparator) within 90 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug
- •4. Treatment with any immunosuppressive medication within 28 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug
- •5. Treatment with an herbal or homeopathic remedy within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study drug
- •6. Treatment with any vaccine within 14 days prior to initiation of study drug or a scheduled vaccination during study period (through the follow-up/early termination visit)
- •7. Treatment with any other (not already described above) prescription or non-prescription medication or dietary supplement (products taken by mouth that contain dietary ingredients such as vitamins, minerals, amino acids, herbs or botanicals) within 14 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug, with the following exceptions:
- •7.1. Oral contraceptives and hormone-releasing intrauterine devices and hormone-replacement therapies
- •7.2. Acetaminophen or paracetamol at a dose of up to 2 g/day
- •8. Positive for TB during screening or within 3 months prior to screening, defined as a positive QuantiFERON®-TB Gold test (QFT)
- •9. Positive HIV test at screening
- •10. Positive hepatitis B surface antigen (HBsAg) test at screening
- •11. Positive hepatitis C virus (HCV) antibody test at screening, except in subjects who meet either of the following sets of criteria:
- •11.1. Subject has undetectable HCV RNA levels for 6 months after completion of HCV anti-viral treatment and a negative HCV RNA test at screening.
- •11.2. Subject has two negative HCV RNA tests taken at least 7 days apart during screening.
- •12. Substance abuse, in the investigator's judgment, within 12 months prior to screening, positive urine drug test at screening or Day -1, or positive breath alcohol test at screening or Day -1
- •13. Positive urine cotinine test at screening or Day -1
- •14. Use of illicit drugs or hallucinogenic substances (including marijuana) within 28 days prior to screening or on at least 30 days within 2 years prior to screening, or unwillingness to abstain from their use during the study
- •15. Use of tobacco or nicotine products within 28 days prior to screening or on at least 30 days within 2 years prior to screening, or unwillingness to abstain from their use during the study
- •16. Receipt of blood products within 120 days prior to screening
- •17. Hospitalization within 28 days prior to initiation of study drug
- •18. Anticipation of need for a surgical procedure during the study
- •19. Infection requiring oral or IV antibiotics within 28 days prior to screening or any evidence of current infection (e.g., bacterial, viral, fungal)
- •20. In the setting of a pandemic or epidemic, screening for active infections should be considered according to local or institutional guidelines or guidelines of applicable professional societies.
- •21. Upper or lower respiratory tract infection within 2 weeks prior to initiation of study drug
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