GS-US-200-5717:A Phase 1 Study in Healthy Participants to Evaluate the Safety,Tolerability, and Pharmacokinetics of Subcutaneous andIntramuscular Lenacapavir

Gilead Sciences0 个研究点目标入组 50 人开始时间: 2023年5月19日最近更新: 2023年10月9日

适应症

试验速览

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•Have the ability to understand and sign a written informed consent form, Be aged 18 through 55 years, be a nonsmoker. The use of nicotine containing products must be discontinued 42 days prior to the administration of the study drug. Have a calculated body mass index not greater than 35.0 kg/m2 at screening, have a creatinine clearance (CLcr) at least 90 mL/min (using the Cockcroft-Gault method{Cockcroft 1976}), Participants who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception, Participants have not donated blood within 56 days of study entry or plasma within 7 days of study entry. Must be willing and able to comply with all study requirements.

•Positive serum or urine pregnancy test, Breastfeeding female, Is currently participating in or has participated in an interventional clinical study with an investigational medicinal product within 30 days prior to study dosing on Day 1 through the duration of the study. Have current alcohol or substance abuse judged by the investigator, Assessed by the investigator as being at risk for HIV infection in the past 6 months, Have a positive test result for HIV at screening, Have a positive test result for hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody at screening. Have taken any prescription medications or over-the-counter medications, including herbal products, within 28 days prior to start of study drug dosing, Have been treated with systemic steroids, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to screening or is expected to receive these agents during the study, Have a history of Significant serious skin disease, Significant drug sensitivity or drug allergy, Known hypersensitivity to the study drug, Significant cardiac disease, Syncope, palpitations, or unexplained dizziness, Implanted defibrillator or pacemaker, Liver disease, including Gilbert syndrome, Severe peptic ulcer disease, gastroesophageal reflux disease, or other gastric acid hypersecretory conditions, Have any serious or active medical or psychiatric illness (including depression).

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