Clinical Trials

TXL

A Multiple Ascending Dose Proof of Concept Study

Overview

Title: A Phase 2, Randomized, Open-label, Ascending, Sequential Dose Group, Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of TXL™ in HBV-infected Subjects

Condition: Infectious Disease

Interventions: TXL™; TDF (Viread)

Objectives

Primary Objective: To evaluate the safety and tolerability of multiple oral (PO) doses of TXL™ at multiple ascending dose levels; to evaluate the antiviral activity of TXL™ versus Tenofovir disproxil fumarate (TDF; Viread)

Secondary Objective: To evaluate the pharmacokinetics (PK) of multiple doses of TXL™ at multiple dose levels in a fasted state

Eligibility

Age: 18 years to 65 years

Gender: Both

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Capable of giving written informed consent
  • Capable of completing study requirements
  • Chronic hepatitis B positive
  • HBV treatment naïve

Exclusion Criteria:

  • Positive result for HCV (hepatitis C virus), HDV (hepatitis D virus) or HIV (human immunodeficiency virus)
  • History or medical condition that could impact patient safety
  • Current or past abuse of alcohol or illicit drugs
  • Abnormal laboratory value or ECG
  • Pregnant or breastfeeding
  • Clinical, histologic or laboratory evidence of significant liver fibrosis or cirrhosis
  • Systemic immunosuppression
  • Received an investigational drug or investigational vaccine within the 90 days prior to the first dose of study drug