A Two-Stage Phase 1 Repeat Dose Study of BaroFeron* (Recombinant Human Interferon beta-1b) Compared to Betaferon® for Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Subcutaneous Administration in Healthy Volunteers - Two-stage phase 1 study with BaroFeron* and BetaFeron®

BaroFold, Inc.0 个研究点目标入组 60 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•Age 18 to 65 years • Body Mass Index (BMI) between 18 and 28 • Negative serum pregnancy test for females of childbearing potential • Good state of health as determined by medical history, physical examination, vital signs measurement, ECG recording, and clinical laboratory tests • Willing and able to give informed consent

•Subjects who have received treatment for any illness within 30 days of the first study drug dosing • Any active viral, bacterial or systemic fungal infection within one week of enrollment • Documented history of or current cardiovascular, renal, hepatic, or immune disorders • Liver enzymes outside laboratory normal range • Drug or alcohol use within 1 week of study entry • Positive drugs screen or alcohol breath test at screening or at admission • Immunotherapy or immunosuppressant treatment within 4 months prior to study entry • Chronic use of NSAIDs within 1 week prior to study entry • History of multiple sclerosis, optic neuritis, or myelitis • Positive serology for Hepatitis B (HBV), Hepatitis C (HCV), or HIV. Must also have no prior history of HBV or HCV virus infection • Prior history of cancer excluding adequately treated basal cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix • Women who are breastfeeding • Unwilling to use an effective method of contraception while on study • Unwilling to abstain from drug, alcohol and cigarette use during study participation • Any prior treatment with interferon alpha (IFN-alpha) or interferon beta (IFN-beta) therapy

发起方