Clinical trial NCT03714152: A Study of ABI-H2158 in Healthy Volunteers and Patients With Chronic Hepatitis B
Official title: A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics, and Food Effect of Single and Multiple Doses of ABI-H2158 in Healthy Volunteers; and the Multiple-Ascending Dose Pharmacokinetics and Pharmacodynamics in Patients With Chronic Hepatitis B Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis B
Keywords: CHB
HBV
hepatitis B
HBeAg positive
Lead sponsor: Assembly Biosciences
Sponsor class: INDUSTRY
First posted: 2018-10-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Healthy volunteers:

1. Male or female between 18 and 55 years old with a BMI of 18-34 kg/m2 with a minimum body weight of 45 kg
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

Chronic HBV patients:

Key Inclusion Criteria:

1. Male or female ≥ 18 and ≤ 65 years of age.
2. In good general health except for chronic HBV infection, documented by:

   1. Clinical history, physical exam and routine laboratory measurements without major or clinically significant findings
   2. Serologic profile consistent with chronic HBV infection • HBeAg-positive at Screening with HBV viral load ≥ 2× 105 IU/mL
3. Liver evaluation demonstrating the absence of bridging fibrosis or cirrhosis

Key Exclusion Criteria:

1. History or evidence of decompensated liver disease at any time prior to Screening
2. History or presence of any other clinically significant current medical conditions requiring ongoing pharmacological treatment.
3. 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).
4. Previous treatment with a commercially approved HBV therapy within the last 6 months

Primary outcomes:
measure: Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events as assessed by CTCAE v4.0.
timeFrame: Up to 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Coronado
country: United States
facility: Southern California Research Center
state: California
city: San Diego
country: United States
facility: Research and Education
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
city: Hillsborough
country: United States
facility: Infectious Disease Care
state: New Jersey
city: Clayton
country: Australia
facility: Monash University
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Linear Clinical Research
state: Western Australia
city: Jilin
country: China
facility: First Hospital of Jilin University
state: Changchun
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong, Queen Mary Hospital
city: Chuncheon
country: Korea, Republic of
facility: Hallym University
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University
city: Auckland
country: New Zealand
facility: Auckland Clinical Studies
city: London
country: United Kingdom
facility: King's College London
Study officials:
References: