Status:
COMPLETED
VNRX-5024 Safety and PK in Healthy Adult Volunteers
Lead Sponsor:
Basilea Pharmaceutica
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 dos...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04314206
Start Date
July 27 2020
End Date
December 31 2020
Last Update
December 3 2025
Active Locations (1)
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1
PRA Health Sciences - Early Development Services
Groningen, Netherlands