A Phase 1, First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PVT201 Following Randomized, Double-blind, Placebo-controlled Single Ascending Doses in Healthy Subjects

Parvus Therapeutics, Inc.0 个研究点目标入组 36 人开始时间: 2024年8月8日最近更新: 2024年8月12日

适应症

试验速览

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•Healthy male or female, 18 to 65 years of age, inclusive with BMI between 18.0 to 32.0 kg/m2, inclusive
•- Carry the HLA DRB4*0101-allele
•- Medically healthy without clinically significant abnormalities based on physical examination, vital signs, ECG, and clinical laboratory tests

•- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease, including any hospitalisation or surgery within the past 4 weeks determined by an Investigator to be clinically relevant
•- Any active infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications
•- History of hypersensitivity reaction, anaphylaxis or other CS reactions or known allergy to the study drug or its ingredients including but not limited to dextran
•- Participant has undergone splenectomy or thymectomy
•- Use of an prescription medications within 14 days prior to the study drug administration or over-the-counter medications (excluding contraceptives), including herbal products and vitamins within 7 days prior to the study drug administration
•- Blood donation within 3 weeks prior to dose administration
•- Use of any vaccinations within 30 days prior to the study drug administration
•- Positive Hepatitis B surface antigen (HBsAg), Hepatitis C (HepC) virus antibody, or human immunodeficiency (HIV) antibody tests
•- History of drug or alcohol abuse

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