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

Venatorx Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Bacterial Infections

Treatments: Drug: Placebo; Drug: VNRX-5133

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT02955459

DMID 16-0014 (Other Identifier)

272201300019C-3-0-1 (U.S. NIH Grant/Contract)

VNRX-5133-101/102

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups, including a placebo group

VNRX-5133

Experimental group

Description:

IV infusion

Treatment:

Drug: VNRX-5133

Placebo

Placebo Comparator group

Description:

IV infusion

Treatment:

Drug: Placebo