NL-OMON52159已完成不适用
A Randomized, Placebo-Controlled, Double-blind, Multiple Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Following Intravenous Administration of SRK-001 in Healthy Participants. - Multiple Dose Study on Safety, Tolerability, and PK of SRK-001
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Participant must be 18 to 65 years of age at the time of signing the
- •informed consent.
- •2. Participants who have clinical chemistry laboratory values within acceptable
- •range for the population, as per investigator judgment
- •3. Body mass index of 18 to 32 kg/m2, inclusive
- •4. Healthy male participants
- •a. Nonvasectomized male participants must agree to abstain from sexual
- •intercourse or use a condom as well as 1 additional highly effective
- •method of contraception (<1% failure rate) or effective method of contraception
- •with all sexual partners of
- •childbearing potential during the study and for 90 days following the last dose
- •of study intervention.
- •b. Must agree not to donate sperm from start of dosing until 90 days beyond the
- •last dose of study intervention.
- •c. No restrictions are required for a vasectomized male provided his vasectomy
- •has been performed and confirmed to be effective by a semen sample lacking
- •sperm at least 3 months or more prior to screening. A male who has been
- •vasectomized or <3 months prior to screening must follow the same restrictions
- •as a nonvasectomized male.
- •5. Healthy female participants of childbearing potential who have a fertile
- •male sexual partner must be willing and able to practice effective
- •contraception from screening to 90 days after 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 so-called
- •'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)
- •d. sexual abstinence, and
- •e. vasectomized partner.
- •Contraceptive requirements do not apply for participants who are exclusively in
- •a same-sex relationship.
- •Further criteria apply, see protocol.
排除标准
- •1. Have any concomitant disorder that, in the opinion of the investigator,
- •would preclude participation in the study.
- •2. For at least 30 days prior to randomization, participants must have no
- •symptoms and/or signs of confirmed or suspected infection (including
- •COVID-19) and must have completed any appropriate anti-infective treatment.
- •3. Have human immunodeficiency virus (HIV) infection.
- •4. Have a current infection with hepatitis B virus (HBV) (that is, positive for
- •hepatitis B surface antigen and/or polymerase chain reaction positive for HBV
- •5. Have a current infection with hepatitis C virus (HCV) (that is, positive for
- •Further criteria apply, see protocol.
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