Status:
TERMINATED
VNRX-9945 Safety and Pharmacokinetics in Healthy Adult Volunteers
Lead Sponsor:
Venatorx Pharmaceuticals, Inc.
Collaborating Sponsors:
Novotech (Australia) Pty Limited
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a 2-part first-in-human dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-9945.
Detailed Description
In Part 1, subjects will receive a single dose of VNRX-9945 or placebo. Subjects enrolled in the food effect cohort will receive a dose in a fasted and fed state (total 2 doses) of VNRX-9945 or placeb...
Eligibility Criteria
Inclusion
- Healthy adults 18-55 years
- Males or non-pregnant, non-lactating females
- Body mass index (BMI) between 18 and 32.0 kg/m2 and total body weight \>50 kg (110 lbs)
- Normal blood pressure
- Normal lab tests
Exclusion
- Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
- History of severe allergic or anaphylactic reaction
- Abnormal ECG or history of clinically significant abnormal rhythm disorder
- Positive alcohol, drug, or tobacco use/test
Key Trial Info
Start Date :
June 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2021
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04845321
Start Date
June 23 2021
End Date
October 31 2021
Last Update
June 10 2025
Active Locations (1)
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1
New Zealand Clinical Research
Auckland, New Zealand