VNRX-5024 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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-27

Study Completion Date

2020-12-31

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 dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-5024. Subjects will be enrolled in one of three dose cohorts. They will receive a single dose on Day 1 in Part 1 and will proceed into the multiple dose Part 2 of the study after safety assessments and PK samples are collected. In the multiple dose part of the study, subjects will receive multiple doses of VNRX-5024 for 10 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-5133 SAD/MAD Safety and PK in Healthy Adult Volunteers

NCT02955459

Bacterial Infections

COMPLETED PHASE1

Single and Multiple Dose Escalation Study of VX-509 in Healthy Subjects

NCT00789126

Healthy

COMPLETED PHASE1

VNRX-9945 Safety and Pharmacokinetics in Healthy Adult Volunteers

NCT04845321

Healthy Volunteers

TERMINATED PHASE1

Safety, Pharmacodynamic and Pharmacokinetic Effects of QAX576 in Healthy Volunteers.

NCT00417196

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.

Healthy Subjects

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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-5024

Capsule formulation

Group Type EXPERIMENTAL

VNRX-5024

Intervention Type DRUG

Part 1: one dose

Part 2:

Cohort 1: 10 doses (once a day for 10 days) Cohort 2: 19 doses (once every 12 hours \[q12h\] dosing for 9 days with a single morning dose on Day 10) Cohort 3: 28 doses (once every 8 hours \[q8h\] dosing for 9 days with a single morning dose on Day 10)

Placebo

Placebo for VNRX-5024

Group Type PLACEBO_COMPARATOR

Placebo for VNRX-5024

Intervention Type DRUG

Part 1: one dose

Part 2:

Cohort 1: 10 doses (once a day for 10 days) Cohort 2: 19 doses (once every 12 hours \[q12h\] dosing for 9 days with a single morning dose on Day 10) Cohort 3: 28 doses (once every 8 hours \[q8h\] dosing for 9 days with a single morning dose on Day 10)

Interventions

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

VNRX-5024

Part 1: one dose

Part 2:

Cohort 1: 10 doses (once a day for 10 days) Cohort 2: 19 doses (once every 12 hours \[q12h\] dosing for 9 days with a single morning dose on Day 10) Cohort 3: 28 doses (once every 8 hours \[q8h\] dosing for 9 days with a single morning dose on Day 10)

Intervention Type DRUG

Placebo for VNRX-5024

Part 1: one dose

Part 2:

Cohort 1: 10 doses (once a day for 10 days) Cohort 2: 19 doses (once every 12 hours \[q12h\] dosing for 9 days with a single morning dose on Day 10) Cohort 3: 28 doses (once every 8 hours \[q8h\] dosing for 9 days with a single morning dose on Day 10)

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

1. Healthy adults 18-55 years
2. Males or non-pregnant, non-lactating females
3. Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2
4. Normal blood pressure
5. Normal lab tests

Exclusion Criteria

1. Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
2. History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug
3. Use of antacid medications
4. Abnormal ECG or history of clinically significant abnormal rhythm disorder
5. Positive alcohol, drug, or tobacco use/test

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes