A Randomized, Double-blind, Placebo-controlled, Sequential group, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of Single and Repeat Doses of Ceftibuten Administered Orally for 10 days in Healthy Adult Volunteers - MAD VNRX-7145 and ceftibuten in healthy subjects

Venatorx Pharmaceuticals, Inc.0 个研究点目标入组 36 人开始时间: 待定最近更新: 2024年4月15日

试验速览

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•1. Willing to participate in the trial, give written informed consent, and
•comply with the trial restrictions.
•2. Gender: male or female; females may be of childbearing potential (using
•highly effective contraception) with a negative serum pregnancy test, or of
•nonchildbearing potential, at screening and Day 1.
•3. Age: 18 to 55 years, inclusive, at screening.
•4. Body mass index (BMI): >=18.5 kg/m2 and <= 30.0 kg/m2.
•5. Normal blood pressure, defined as a systolic value greater than or equal to
•90 mm Hg and less than 140 mm Hg and a diastolic value greater than or equal to
•45 mm Hg and less than 90 mm Hg (screening and Day -1).
•Further criteria apply

•1. Employee of the CRO, CRC, or the Sponsor.
•2. Female (or male with a partner) who is pregnant, lactating, or planning to
•attempt to become pregnant during this study or within 90 days after the last
•administration of study drug.
•3. Use of any investigational drug or device within 30 days prior to screening
•(90 days for an injectable biological agent). Participation in more than 4
•other drug studies in the 12 months prior to the first drug administration in
•the current study.
•4. Congenital or acquired immunodeficiency syndrome.
•5. History or presence of current cardiovascular, respiratory, hepatic, renal,
•gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurologic
•disorders or any other disease that, in the opinion of the Investigator, poses
•an unacceptable risk to the subject.
•Further criteria apply

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