VNRX-5133 SAD/MAD Safety and PK in Healthy Adult Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Bacterial Infections

In brief

This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of VNRX-5133 administered via intravenous (IV) infusion in healthy subjects. In part 1, subjects will receive a single dose of VNRX-5133; in part 2 subjects will receive VNRX-5133 for 7 days.

Key facts

Study ID

NCT02955459

Run by

Venatorx Pharmaceuticals, Inc.

People needed

84

Starts

2016-11-01

Expected to finish

2017-06-01

Last updated by the study team

2017-07-21

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy adults
• Males or non-pregnant, non-lactating females
• Body Mass Index (BMI) between 18.5 - 32.0, inclusive.
• Suitable veins for cannulation

You may not qualify if…

• Employee of site or the sponsor
• Any disease that poses an unacceptable risk to participants
• Abnormal ECG
• Abnormal labs
• Abnormal vital signs
• Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
• Positive serology for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) type 1
• Current smokers or history of smoking within 30 days

Where it is running

• Study site — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

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