VNRX-5024 Safety and PK in Healthy Adult Volunteers
- Registration Number
- NCT04314206
- Lead Sponsor
- Venatorx Pharmaceuticals, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- Healthy adults 18-55 years
- Males or non-pregnant, non-lactating females
- Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2
- Normal blood pressure
- Normal lab tests
Exclusion Criteria
- Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
- History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug
- Use of antacid medications
- Abnormal ECG or history of clinically significant abnormal rhythm disorder
- Positive alcohol, drug, or tobacco use/test
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description VNRX-5024 VNRX-5024 Capsule formulation Placebo Placebo for VNRX-5024 Placebo for VNRX-5024
- Primary Outcome Measures
Name Time Method Number of subjects with adverse events Day 19
- Secondary Outcome Measures
Name Time Method Part 1: AUC0-tau Days 1-2 Part 2: AUC0-tau Days 3-12 Part 1: Cmax Days 1-2 Part 2: Cmax Days 3-12 Part 1: tmax Days 1-2 Part 2: tmax Days 3-12 Part 1: CLr Days 1-2 Part 2: CLr Days 3-12
Trial Locations
- Locations (1)
PRA Health Sciences - Early Development Services
🇳🇱Groningen, Netherlands