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临床试验/NL-OMON51149
NL-OMON51149已完成不适用

A Randomized, Drug-Drug Interaction Study to Assess the Safety and Pharmacokinetics of VNRX­7145 and Ceftibuten (VNRX­5024) in Healthy Adult Volunteers - DDI on safety of PK of VNRX-7145 and Ceftibuten (VNRX-5024)

Venatorx Pharmaceuticals, Inc.0 个研究点目标入组 54 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
入组人数
54
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 64（—）

入选标准

  • •1. Willing to participate in the study, give written informed consent, and
  • •comply with the study restrictions including lifestyle restriction outlined in
  • •Section 6.4 of the protocol.
  • •2. Healthy male and female .subjects between 18 and 55 years of age (inclusive).
  • •3. Body mass index (BMI): >=18.5 kg/m2 and <=32.0 kg/m2, at Screening.
  • •4. Normal blood pressure at Screening and Day -1, defined as a systolic value
  • •greater than or equal to 90 mm Hg and less than or equal to 140 mm Hg and a
  • •diastolic value less than 90 mm Hg. Values outside the range for inclusion may
  • •be retested once if there is a clinical rationale for the out-of-range value.
  • •5. Urine dipstick results for protein are negative or trace at Screening and

排除标准

  • •1. Employee or family members of the clinical research organization (CRO), CRC,
  • •or the Sponsor.
  • •2. Female who is pregnant, lactating, or planning to attempt to become pregnant
  • •during this study or within 90 days after dosing of study drug.
  • •3. Male with a female partner who is pregnant or lactating or planning to
  • •become pregnant within 90 days after the last dose of study drug administration.
  • •4. Subject is participating in any other clinical study that involves the
  • •administration of an investigational product at the time of screening or during
  • •the course of the study or has received treatment with an investigational
  • •product in the 30 days before Screening (90 days for an injectable biological
  • •agent). See Protocol Section 7.6 Concomitant Treatment for more details.
  • •5. Subject has a congenital or acquired immunodeficiency syndrome.

研究者

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