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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

VNRX-7145 SAD/MAD Safety and PK in Healthy Adult Volunteers

NCT04243863

Healthy Volunteers

COMPLETED PHASE1

VNRX-5024 Safety and PK in Healthy Adult Volunteers

NCT04314206

Healthy Subjects

COMPLETED PHASE1

Study Evaluating the Safety and Tolerability of Single Ascending Dose (SAD) SLV-351 in Healthy Subjects

NCT00581191

Healthy

TERMINATED PHASE1

Safety, Tolerability, and Dose Response of VNA-318 in Healthy Males

NCT06721091

Healthy Volunteer

COMPLETED PHASE1

A Single Dose Study Of The Safety And Investigational Product Level Measurement In Healthy Subjects

NCT01284036

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bacterial Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

VNRX-5133

IV infusion

Group Type EXPERIMENTAL

VNRX-5133

Intervention Type DRUG

Placebo

IV infusion

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

VNRX-5133

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes