NCT03714152

Brief Summary

This three-part, Phase 1 protocol will be the first clinical study of ABI-H2158. Parts 1 and 2 will be a Phase 1a, dose-ranging assessment of ABI-H2158 in healthy adult volunteers. If the dose-related safety, tolerability, and pharmacokinetics (PK) of ABI-H2158 in healthy volunteers are deemed satisfactory, then the study will advance to Part 3, a Phase 1b, dose-ranging assessment of ABI-H2158 in non-cirrhotic, CHB patients.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2018

Typical duration for phase_1

Geographic Reach
7 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 22, 2018

Completed
22 days until next milestone

Study Start

First participant enrolled

November 13, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2021

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

October 17, 2018

Last Update Submit

January 26, 2021

Conditions

Chronic Hepatitis B

Keywords

CHBHBVhepatitis BHBeAg positive

Outcome Measures

Primary Outcomes (1)

  • Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events as assessed by CTCAE v4.0.

    Up to 28 days

Study Arms (2)

ABI-H2158

EXPERIMENTAL

ABI-H2158 in varying doses of tablets by mouth without and with food for 1 day or 10 days

Drug: ABI-H2158

Matching Placebo for ABI-H2158

PLACEBO COMPARATOR

Matching Placebo in varying doses of tablets by mouth without and with food for 1 day or 10 days

Drug: Placebo for ABI-H2158

Interventions

ABI-H2158DRUG

5 mg or 25 mg tablets

ABI-H2158
Placebo for ABI-H2158DRUG

Sugar pill manufactured to mimic the ABI-H2158 5 mg or 25 mg tablets

Matching Placebo for ABI-H2158

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female ≥ 18 and ≤ 65 years of age.
  • In good general health except for chronic HBV infection, documented by:
  • Clinical history, physical exam and routine laboratory measurements without major or clinically significant findings
  • Serologic profile consistent with chronic HBV infection • HBeAg-positive at Screening with HBV viral load ≥ 2× 105 IU/mL
  • Liver evaluation demonstrating the absence of bridging fibrosis or cirrhosis

You may not qualify if:

  • History or evidence of decompensated liver disease at any time prior to Screening
  • History or presence of any other clinically significant current medical conditions requiring ongoing pharmacological treatment.
  • Previous treatment with any investigational HBV antiviral treatments within the last 6 months, or previous treatment at any time with an investigational HBV antiviral treatment of the same class (core protein targeted therapies).
  • Previous treatment with a commercially approved HBV therapy within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Southern California Research Center

Coronado, California, 92118, United States

Location

Research and Education

San Diego, California, 92115, United States

Location

Quest Clinical Research

San Francisco, California, 94115, United States

Location

Infectious Disease Care

Hillsborough, New Jersey, 08844, United States

Location

Monash University

Clayton, Victoria, Australia

Location

The Alfred Hospital

Melbourne, Victoria, Australia

Location

Linear Clinical Research

Nedlands, Western Australia, Australia

Location

First Hospital of Jilin University

Jilin, Changchun, 130000, China

Location

University of Hong Kong, Queen Mary Hospital

Hong Kong, Hong Kong

Location

Auckland Clinical Studies

Auckland, New Zealand

Location

Hallym University

Chuncheon, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Severance Hospital, Yonsei University

Seoul, South Korea

Location

King's College London

London, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis B, ChronicHepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2018

First Posted

October 22, 2018

Study Start

November 13, 2018

Primary Completion

November 23, 2020

Study Completion

January 7, 2021

Last Updated

January 27, 2021

Record last verified: 2021-01

Locations

NZ(1)GB(1)AU(3)US(4)HK(1)CN(1)KR(3)