NL-OMON50998已完成不适用
A Safety, Tolerability and Pharmacokinetic Study of Single and Multiple Doses of LY3526318 in Healthy Participants - A safety, PK and pilot FE study of LY3526318 in healthy participants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Eli Lilly
- 入组人数
- 16
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Aged 18 to 65 years, inclusive.
- •2. Healthy male participants, as determined through medical history and physical
- •examination.
- •a. A nonvasectomized, male participant must agree to use a condom or abstain
- •sexual intercourse from start of dosing until 105 days beyond the last dose of
- •intervention.
- •b. No restrictions are required for a vasectomized male provided his vasectomy
- •performed at least 4 months or prior to screening. A male who has been
- •vasectomized
- •*4 months prior to screening must follow the same restrictions as a
- •nonvasectomized
- •c. Must agree not to donate sperm from start of dosing until 105 days beyond
- •dose of study intervention.
- •3. Healthy female participants of child-bearing potential who have a fertile
- •male sexual
- •partner must be willing and able to practice effective contraception from
- •admission to
- •105 days beyond the last dose of study intervention. Sexually active
- •participants must use
- •a combination of 2 of the following methods of contraception, including at
- •least 1 socalled
- •*barrier* method:
- •a. hormonal contraceptives (oral, transdermal patches, vaginal, or injectable)
- •b. intrauterine device with or without hormones
- •c. condom, diaphragm, or cervical cap (*barrier* method), and
- •d. sexual abstinence.
- •Contraceptive requirements do not apply for participants who are exclusively in
- •a same-sex
- •relationship. Additional guidance is provided in Section 10.4, Appendix 4.
- •4. Have a body mass index of 18 to 32 kg/m2, inclusive.
- •5. Are reliable and willing to make themselves available for the duration of
- •the study and
- •are willing to follow CRU-specific study procedures.
- •6. Have clinical laboratory test results within normal reference range for the
- •population or
- •CRU, or results with acceptable deviations that are judged not clinically
- •significant by the
- •investigator.
- •7. Capable of giving signed informed consent as described in Section 10.1.2,
- •Appendix 1,
- •which includes compliance with the requirements and restrictions listed in the
- •consent form (ICF) and in this protocol.
排除标准
- •1. Have a history or presence of medical illness including, but not limited to,
- •cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or
- •neurological
- •disease, convulsions, or any clinically significant laboratory abnormality
- •that, in the
- •judgment of the investigator, indicate a medical problem that would preclude
- •participation.
- •2. Any abnormalities identified following a physical examination of the
- •participant that, in
- •the opinion of the investigator, would jeopardize the safety of the participant
- •or interfere
- •with study conduct if they took part in the study.
- •3. Positive SARS-CoV-2 virus nasopharyngeal polymerase chain reaction test at
- •4. Contact with SARS-CoV-2-positive or COVID-19 patient within the last 14 days
- •admission to the CRU.
研究者
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