A randomized, blinded, placebo-controlled study to assess the safety, tolerability and pharmacokinetics of EGT710 following administration of single and multiple doses to healthy adults. - Safety, Tolerability, and Pharmacokinetics of EGT710 in HV.

ovartis Pharma AG0 个研究点目标入组 100 人开始时间: 待定最近更新: 2024年4月9日

研究概览

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•Able and willing to provide written informed consent.
•Healthy male or female participants 18 to 65 years of age, inclusive, at the
•time of screening, and in good health as determined by past medical history,
•physical examination, vital signs, electrocardiogram, and
•laboratory tests at screening and baseline.
•Participants must weigh at least 50 kg at screening and baseline to
•participate in the study, and must have a body mass index (BMI) of less than or
•equal to 35.0 kg/m2. BMI = Body weight (kg) / [Height (m)]2.
•Further criteria apply, see protocol.

•Women of child-bearing potential, defined as all women physiologically capable
•of becoming pregnant. All potential female participants will be considered
•physiologically able to become pregnant UNLESS they have had:
•(i) 12 months of natural (spontaneous) amenorrhea with an appropriate clinical
•profile (e.g. age-appropriate amenorrhea, history of vasomotor
•symptoms) or
•(ii) surgical bilateral oophorectomy (with or without hysterectomy) or total
•hysterectomy at least six weeks prior to screening with confirmatory FSH
•measurements at screening.
•Sexually active males unwilling to use a condom during intercourse while
•taking study treatment and for 4 weeks after stopping study treatment. A condom
•is required for all sexually active male participants to prevent them from
•fathering a child AND to prevent delivery of study treatment via seminal fluid
•to their partner. In addition, male participants must not donate sperm for the
•time period specified above.
•Significant illness which has not completely resolved within one (1) week
•prior to initial dosing.
•Use of other investigational drugs at the time of enrollment, or within 5
•half-lives of enrollment (if known), or within 30 days, whichever is longer; or
•longer if required by local regulations.
•Further criteria apply, see protocol.

发起方