ACTRN12618001461280已完成1 期
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Studyto Evaluate the Safety and Tolerability of LPT99 Administered to Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1. Male or female subject, age 18 to 65 years (inclusive) at Screening
- •2. Provides written informed consent prior to participation in any study procedure
- •3. Normal hearing, defined as is greater than or equal to 20 dB from 250 Hz to 8 kHz bilaterally
- •4. Normal tympanogram
- •5. No known allergies to lidocaine or prilocaine local anesthesia, to EMLA® (lidocaine
- •2.5% and prilocaine 2.5%) cream, or to phenol
- •6. Female subjects of childbearing potential, must not be pregnant, lactating, or planning
- •a pregnancy, must have a negative pregnancy test at screening and at Day -1, and
- •must use a medically acceptable method of contraception [e.g., intrauterine device
- •(IUD), intrauterine system (IUS), or hormonal contraception (oral, implant, or
- •injectable) begun >30 days prior to screening]. Acceptable contraceptive options may
- •also include abstinence (if this is the preferred lifestyle for the participant), physical
- •relationship with a same-sex partner or a partner who has had a vasectomy at least 6
- •months prior to Screening. Subjects must agree to adhere to contraceptive measures
- •from screening through 30 days after study drug administration.
- •7. Male subjects must be surgically sterile (vasectomy at least 6 months prior to
- •screening) or practice acceptable methods of contraception, and must agree to abstain
- •from sperm donation, from study drug administration through 90 days after
- •administration of study drug. Male subjects must agree to use a condom to protect
- •male and female partners from exposure to study drug. Male subjects with female
- •partners of childbearing potential, must also agree to partner use of hormonal
- •contraception (oral, implant, or injection), an IUD, or an IUS. Complete abstinence
- •from sexual intercourse, if this is the preferred lifestyle for the participant, is an
- •acceptable contraceptive option.
排除标准
- •1. Bleeding disorder that could affect the TT study drug administration
- •2. Use of anticoagulant medication within 30 days prior to screening.
- •3. History of surgery to the inner ear
- •4. History of chronic tinnitus or Meniere's disease
- •5. History of radiation therapy to the head or neck
- •6. History of chronic middle ear infection, endolymphatic sac surgery
- •7. History of known hypersensitivity to any components of the study drug or formulation
- •8. Positive alcohol or urine drug test at Screening or on Study Day -1
- •9. Positive pregnancy test at Screening or on study Day -1
- •10. Acute illness or history of illness, that, in the opinion of the Investigator, could pose a
- •threat to or harm the subject, or obscure interpretation of laboratory test results or
- •11. Acute respiratory infection, acute nasopharyngitis, sinusitis, chronic cough, or
- •symptoms of allergic rhinitis
- •12. Any clinically significant abnormalities on Screening or Day -1 laboratories, as
- •determined by the Investigator
- •13. Abnormality of tympanic membrane (perforation, retraction, history of any ear
- •surgery, effusion or other middle ear pathology) that would preclude TT
- •administration
- •14. Received study drug or placebo in another clinical study within the 30 days prior to
- •study drug administration
- •15. Deemed unsuitable for study participation by the Investigator, based on the
- •Investigator's judgment
研究者
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