Clinical Trials

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: All

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

Overview

Title: A Phase 1, Randomized, Partial-Blind, Placebo-controlled, Sequential Dose Group, Ascending, Multiple Dose Study of the Safety, Tolerability and Pharmacokinetics, With Food Effect, of TXL in Healthy Subjects

Condition: Infectious Disease

Interventions: TXL; Placebo

Objectives

Primary Objective: To evaluate the safety and tolerability of multiple oral (PO) doses of TXL at increasing dose levels

Secondary Objective: To evaluate the pharmacokinetics of multiple doses of TXL at increasing dose levels, in a fasted state; to evaluate the pharmacokinetics of a single dose of TXL 50 mg in a fed state

Eligibility

Age: 18 years to 55 years

Gender: All

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Capable of giving written informed consent
  • Capable of completing study requirements

Exclusion Criteria:

  • Positive result for HIV, HBV, or HCV
  • History or medical condition which could impact patient safety
  • Current or past abuse of alcohol or illicit drugs
  • Participation in another clinical trial within the past 30 days

Overview

Title: A Randomized, Partially-blinded, Placebo-controlled, Ascending Sequential Dose Groups, Single Dose Study of the Safety, Tolerability and Pharmacokinetics of CRV431, Alone and In Combination With Tenofovir Disoproxil Fumarate in Healthy Subjects, With a Pilot Study of Multiple Ascending Sequential Doses in HBV-Infected Subjects on Chronic Tenofovir Disoproxil Fumarate Treatment

Condition: Infectious Disease

Interventions: CRV431, Placebo, TDF (Viread®)

Objectives

Part 1: To assess the safety, tolerability, and PK of a single dose of CRV431 in healthy volunteers

Part 2: Single dose drug-drug interaction study in healthy volunteers with CRV431 co-treated with TDF

Part 3: To assess the safety, tolerability, PK, and preliminary signal for antiviral efficacy and identification of clinically-relevant biomarkers of CRV431 with TDF in stable HBV patients

Eligibility

Age: 18 years to 55 years (Adult)

Gender: All

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Capable of giving written informed consent
  • Willing and able to complete all study requirements
  • Healthy male or female between 18 and 55 years of age (inclusive)
  • Body mass index 16 to 32 kg/m2 (inclusive)

Exclusion Criteria:

  • Positive test for HCVAb or HIVAb. For healthy subjects only: positive test for HBsAg
  • Current or history of abuse of alcohol or illicit drugs
  • Received an investigational drug, vaccine or medical device within 90 days prior to first dose of study drug