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A Study in Healthy Volunteers and Patients With Chronic Hepatitis B

This study is currently recruiting participants.
Verified July 2017 by Assembly Biosciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT02908191
First Posted: September 20, 2016
Last Update Posted: July 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Assembly Biosciences
  Purpose
This two-part, Phase 1 protocol will be the first clinical study of ABI-H0731. Part I will be a Phase 1a dose-ranging assessment of ABI-H0731 in healthy adult volunteers. If the dose-related safety, tolerability and pharmacokinetics (PK) of ABI-H0731 in human volunteers are deemed satisfactory, then the study will advance to Part II, a Phase 1b dose-ranging assessment of ABI-H0731 in non-cirrhotic, CHB patients.

Condition Intervention Phase
Chronic Hepatitis B Drug: ABI-H0731 Drug: Placebo for ABI-H0731 Drug: Entecavir Drug: Tenofovir disoproxil fumarate Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1a/1b, Dose-Ranging Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of ABI-H0731 in Healthy Volunteers and Patients With Chronic Hepatitis B

Resource links provided by NLM:


Further study details as provided by Assembly Biosciences:

Primary Outcome Measures:
  • Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events as assessed by CTCAE v4.0. [ Time Frame: Up to 57 days ]

Estimated Enrollment: 114
Actual Study Start Date: November 2016
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABI-H0731
ABI-H0731 in varying doses of tablets by mouth for 1 day, 7 days, or 28 days
Drug: ABI-H0731
Placebo Comparator: Placebo for ABI-H0731
Placebo for ABI-H0731 in varying doses of tablets by mouth for 1 day, 7 days, or 28 days
Drug: Placebo for ABI-H0731
Other Name: Sugar pill manufactured to mimic the ABI-H0731 tablet
Experimental: ABI-H0731 and Entecavir or Tenofovir Disoproxil Fumarate
ABI-H0731 and entecavir or tenofovir in combination in a yet to be determined dose by mouth for 28 days
Drug: ABI-H0731 Drug: Entecavir Drug: Tenofovir disoproxil fumarate

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Healthy volunteers:

  1. Male or female between 18 and 65 years old with a BMI of 18-32kg/m2
  2. Must be in good health and not have any health condition which could interfere with the absorption, distribution or elimination of study drug, or with the clinical and laboratory assessments in this study

CHB patients:

  1. Male or female between 18 and 65 years of age, with a BMI of 18-35kg/m2
  2. Must have chronic hepatitis B with no history of clinical decompensation
  3. Must not have been treated for hepatitis B before
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02908191


Contacts
Contact: Assembly Biosiences clinicaltrials@assemblybio.com

Locations
New Zealand
Recruiting
Auckland, New Zealand
Recruiting
Hamilton, New Zealand
Sponsors and Collaborators
Assembly Biosciences
  More Information

Responsible Party: Assembly Biosciences
ClinicalTrials.gov Identifier: NCT02908191     History of Changes
Other Study ID Numbers: ABI-H0731-101
First Submitted: September 14, 2016
First Posted: September 20, 2016
Last Update Posted: July 7, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Tenofovir
Entecavir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents