VNRX-7145 SAD/MAD Safety and PK in Healthy Adult Volunteers

Basilea Pharmaceutica83 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers

Interventions

VNRX-7145DRUG

Part 1: one dose Part 2: 28 doses (once every 8 hour \[q8h\] dosing for 9 days with a single morning dose on Day 10)

PlaceboDRUG

Part 1: one dose Part 2: 28 doses (once every 8 hour \[q8h\] dosing for 9 days with a single morning dose on Day 10)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Worldwide Clinical Trials Early Phase Services, LLC

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Part 1: Number of subjects with adverse events

Time frame: Day 8

Part 2: Number of subjects with adverse events

Time frame: Day 17

Secondary Outcomes

Part 1: AUC0-tau

Time frame: Days 1-3

Part 1: Cmax

Time frame: Days 1-3

Part 1: tmax

Time frame: Days 1-3

Part 1: CLr

Time frame: Days 1-3

Part 2: AUC0-tau

Time frame: Days 1-10

Part 2: Cmax

Time frame: Days 1-10

Part 2: tmax

Time frame: Days 1-10

Part 2: CLr

Time frame: Days 1-10

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.