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

Basilea Pharmaceutica

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: VNRX-7145

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT04243863

18-0012 (Other Identifier)

272201600029C-P00007-9999-2 (U.S. NIH Grant/Contract)

VNRX-7145-101

Details and patient eligibility

About

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.

Enrollment: 83 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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83 participants in 2 patient groups, including a placebo group

VNRX-7145

Experimental group

Description:

Oral dosing

Treatment:

Drug: VNRX-7145

Placebo

Placebo Comparator group

Description:

Oral dosing

Treatment:

Drug: Placebo