Part A, B and D: A 4-Part Dose-Escalation, Food Effect, And Drug-Drug Interaction Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of SGR-1505 In Healthy Volunteers

Schrödinger, Inc0 个研究点目标入组 60 人开始时间: 2023年4月6日最近更新: 2023年12月12日

适应症

试验速览

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•1. Male or female participant must be between 18 and 60 years of age (inclusive) at the time of signing the informed consent form (ICF).
•2. Participant must understand and sign an ICF prior to any study-related assessments/procedures being conducted.
•3. Body mass index (BMI) of 18.0 to 32.0 kg/m2 (inclusive) with a minimum body weight of 45 kg.
•4. Participant must be able to comply with the study protocol and adhere to the study visit schedule in the Investigator’s judgment.
•5. Participant must be in good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations at Screening and upon check-in as assessed by the Investigator (or designee), as applicable.
•6. Women of childbearing potential must have a negative serum pregnancy test within 14 days of the first dose of study treatment (during screening), and a negative serum or urine pregnancy test within 24 hours of the first dose of study treatment.
•7. Men and women of childbearing potential must agree to use highly effective contraception and refrain from egg or sperm donation throughout the study (from signing of the ICF and for 90 days after the last dose of study drug).

•1. Diseases or conditions known to interfere with absorption, distribution, metabolism, or excretion of drugs.
•2. Use of any investigational drug within 30 days, or 5 half-lives, whichever is longer, prior to the planned first drug administration.
•3. Participant with any clinically significant active symptoms at time of enrollment.
•4. Participant has a known allergy to SGR-1505, components of SGR-1505, or an allergy to Posaconazole for participants considered for enrollment into the DDI cohort.
•5. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inhibitor or inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication.
•6. Participants with known history of Gilbert’s syndrome.
•7. Participants with chronic jaundice and/or a known familial history of jaundice.
•8. Participants who are pregnant, breastfeeding or intending to become pregnant during the study or within 90 days after the last dose of study treatment.
•9. Participant has any condition, including clinically significant acute bacterial, viral, or fungal infection which places the participant at unacceptable risk if he/she were to participate in the study.

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