VNRX-7145 SAD/MAD Safety and PK in Healthy Adult Volunteers
- Registration Number
- NCT04243863
- Lead Sponsor
- Venatorx Pharmaceuticals, Inc.
- Brief Summary
This is a 2-part, first-in-human dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-7145. In part 1, subjects will receive a single dose of VNRX-7145; in part 2 subjects will receive multiple doses of VNRX-7145 for 10 days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
Inclusion Criteria
- Healthy adults 18-45 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 laboratory tests
Exclusion Criteria
- Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
- History of drug allergy
- Abnormal ECG or history of clinically significant abnormal rhythm disorder
- Positive alcohol, drug, or tobacco use/test
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description VNRX-7145 VNRX-7145 Oral dosing Placebo Placebo Oral dosing
- Primary Outcome Measures
Name Time Method Part 1: Number of subjects with adverse events Day 8 Part 2: Number of subjects with adverse events Day 17
- Secondary Outcome Measures
Name Time Method Part 1: AUC0-tau Days 1-3 Part 1: Cmax Days 1-3 Part 1: tmax Days 1-3 Part 1: CLr Days 1-3 Part 2: AUC0-tau Days 1-10 Part 2: Cmax Days 1-10 Part 2: tmax Days 1-10 Part 2: CLr Days 1-10
Trial Locations
- Locations (1)
Worldwide Clinical Trials Early Phase Services, LLC
🇺🇸San Antonio, Texas, United States