NL-OMON50446已完成不适用
A Two-Part, Open-Label, Single-Dose Relative Bioavailability and Food Effect Study of THB001 in Healthy Adults - CS0375-210372
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
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. Subjects must understand the nature of the study and must provide signed and
- •dated written informed consent in accordance with local regulations before the
- •conduct of any study-related procedures.
- •2. Healthy as determined by the Investigator, based on a medical evaluation
- •including medical history, physical examination, laboratory tests and ECG
- •recording. A subject with a clinical abnormality or laboratory parameters
- •outside the reference range for the population being studied may be included
- •only if, in the opinion of the Investigator, the finding is (a) unlikely to
- •introduce additional risk to the subject, (b) will not interfere with study
- •procedures or confound study results, and (c) is not otherwise exclusionary
- •(see Exclusion Criteria).
- •3. Men and women, age 18-65 years inclusive at Screening will be enrolled.
- •4. Women of child-bearing potential must agree not to attempt to become
- •pregnant and to use a highly effective form of hormonal (excluding oral
- •contraceptives) or non-hormonal birth control, which entails the use of a
- •non-hormonal intra-uterine device/system in combination with a barrier method
- •(e.g. condom, diaphragm, cervical cap with spermicide) or abstinence during the
- •study and for 90 days after the last study drug administration. Postmenopausal
- •women must have had >=12 months of spontaneous amenorrhea (with documented
- •follicle-stimulating hormone (FSH) >=30 mIU/mL). Surgically sterile women are
- •defined as those who have had a hysterectomy, bilateral ovariectomy, or
- •bilateral tubal ligation. Women who are surgically sterile must provide
- •documentation of the procedure by a letter from their GP. All women must have a
- •negative pregnancy test result at Screening and on Day -1 before first
- •administration of study medication.
- •5. It is important that male subjects not impregnate others while in the study.
- •Therefore, male subjects who are biologically capable of having children must:
- •- Remain sexually abstinent, when this is in line with his preferred and usual
- •- Engage exclusively in same-sex relationships.
- •- Agree to avoid impregnating his partner during the study (including washout
- •periods) and for at least 90 days after the last dose of study medication.
- •- Must use a combination of two methods of contraception during the study
- •(including washout periods) and for at least 90 days after the last dose of
- •study medication. One of the contraceptive methods must be a condom with
- •spermicide (this is considered a single method). The second contraceptive
- •method must include one of the following: diaphragm in combination with a
- •spermicide; intrauterine device (IUD); contraception implant; progesterone-only
- •pills (POPs); injectable progestogen (Depo-Provera®); combination hormonal
- •contraceptive method (tablets, patches, or vaginal ring with both oestrogen and
- •progestogen), OR have a partner who had her last natural menstruation >=24
- •months prior to the Screening Visit, OR have a partner who was surgically
- •sterilized prior to the Screening Visit.
- •- Not donate sperm during the study (including washout periods) and for at
- •least 90 days after the last dose of study drug.
- •- Male subjects who have had a vasectomy at least 4 months prior to the
- •Screening Visit and must have completed post-surgical follow up to confirm
排除标准
- •1. A positive urine drug screen/alcohol breath test at Screening or Day -1 of
- •the first treatment period.
- •2. A positive Hepatitis B surface antigen or positive Hepatitis C antibody
- •result at Screening.
- •3. A positive test for human immunodeficiency virus (HIV) antibody at
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