Overview
A Study Evaluating AHB-137 in Healthy Participants and Participants With Chronic Hepatitis B
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2024-11-30
2024-11-30
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of AHB-137 subcutaneous injection in healthy volunteers and in chronic hepatitis B (CHB) patients after single and multiple doses. In addition, the study will evaluate the antiviral efficacy of AHB-137 in CHB patients following a multiple dosing regimen.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Ausper Biopharma Co., Ltd.
Criteria
Inclusion Criteria:- Healthy participants are required to meet all the following inclusion criteria in
order to be enrolled in the study:
1. 18-65 years old male or female.
2. Body Mass Index (BMI) between 19 to 35 kg/m2 (inclusive) and body weight equal to
or over 45 kg.
3. Healthy female volunteers cannot be pregnant at the time of recruiting and during
the study. Healthy female volunteers with childbearing potential must remain
abstinent or use two methods of contraception with their partner, one of which
must be a barrier method (E.g. condom), for the duration of the study and for at
least 3 months after the last dose of study-drug.
4. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or
use contraceptive measures, and agreement to refrain from donating sperm.
5. Participants' COVID-19 PCR test should be negative during screening.
6. Participants' COVID-19 Rapid Antigen Test (RAT) should be negative at check-in.
- CHB patients are required to meet all the following inclusion criteria in order to be
enrolled in the study:
1. Have given written informed consent (signed and dated) and any authorizations
required by local law and is able to comply with all study requirements.
2. Age 18 to 65 years old.
3. ALT < 5 ULN.
4. CHB patients who have documented chronic HBV infection equal to or above 6 months
prior to screening. Otherwise, CHB patients need to be HBsAg positive and IgM
HBcAb negative.
5. Female patients cannot be pregnant at the time of recruiting and during the
study. Healthy female volunteers with childbearing potential must remain
abstinent or use two methods of contraception with their partner, one of which
must be a barrier method (E.g. condom), for the duration of the study and for at
least 3 months after the last dose of study-drug. For male patients: agreement to
remain abstinent (refrain from heterosexual intercourse) or use contraceptive
measures, and agreement to refrain from donating sperm.
6. Participants receiving stable nucletos(t)ide analogue (NA) therapy were expected
to continue NA therapy during the trial; participants not receiving NA therapy at
the time of trail entry were expected to continue without NA during the trail.
7. COVID-19 PCR test should be negative during screening.
8. COVID-19 RAT test should be negative at check-in.
Exclusion Criteria:
- Healthy participants are required to not meet any of the exclusion criteria in order
to be enrolled in the study:
1. Pregnant (positive pregnancy test) or lactating women. Male participants without
using proper contraceptives (e.g. condom) with partners who are pregnant or
lactating.
2. History or symptoms of any clinically significant gastrointestinal, renal,
hepatic, bronchopulmonary, neurological, psychiatric, cardio-vascular,
endocrinological, hematological or allergic disease, metabolic disorder, cancer
or cirrhosis.
3. Personal history of congenital long QT syndrome or family history of sudden
cardiac death.
4. Any confirmed significant allergic reactions (urticaria or anaphylaxis) against
any drug, or multiple drug allergies (non-active hay fever is acceptable).
5. Any clinically significant concomitant diseases or condition that could interfere
with, or treatment of which might interfere with, the conduct of the study, or
that would, in the opinion of the Investigator, pose an unacceptable risk to the
participant in this study.
6. Clinically relevant electrocardiogram (ECG) abnormalities on screening ECG.
7. ECG with QRS and/or T-wave judged to be unfavorable for a consistently accurate
QT measurement.
8. Creatinine clearance (CrCl) cutoff = 80 ml/min (using the Cockcroft-Gault
formula).
9. Positive test at screening of any of the following: hepatitis A (HAV IgM Ab),
hepatitis B (HBsAg), hepatitis C (HCV RNA or HCV Ab), human immunodeficiency
virus 1 and 2 (HIV Ab), or TP-Ab.
10. Any other clinically significant abnormalities in laboratory test results at
screening. In the case of uncertain or questionable results, tests performed
during screening may be repeated before randomization to confirm eligibility.
11. History of bleeding diathesis or coagulopathy.
CHB patients are required to not meet any of the exclusion criteria in order to be enrolled
in the study:
1. History of liver cirrhosis and/or evidence of cirrhosis as determined by any 1 of the
following:
1. Liver biopsy (i.e., Metavir Score F4) within 2 years of screening, or
2. FibroScan > 12 KPa, within 12 months of screening, or
3. AST-to-Platelet Index (APRI) > 2 and FibroSure result > 0.7 within 12 months of
screening.
For patients without a test for cirrhosis in the above timeframes, FibroScan, or APRI
and FibroSure, may be performed during the screening period to rule out cirrhosis
History of liver failure as evidenced by ascites, hepatic encephalopathy, and/or
gastric or esophageal varices.
2. History of liver disease other than hepatitis B.
3. Co-infection with TP, HCV, HIV, or hepatitis D virus (HDV).
4. Body mass index >35 kg/m2 .
5. History or suspected presence of vasculitis .
6. Diagnosed hepatocellular carcinoma or suspected hepatocellular carcinoma as evidenced
by screening alpha-fetoprotein ≥200 ng/mL. If the screening alpha-fetoprotein is ≥50
ng/mL and <200 ng/mL, the absence of liver mass must be documented by imaging within 6
months before randomization.
7. Clinically relevant electrocardiogram (ECG) abnormalities on screening ECG.
8. Screening laboratory results as follows, or any other clinically significant
abnormalities in screening laboratory values that would render a patient unsuitable
for inclusion.
1. ALT or Aspartate-amino-transferase (AST) > 5 x ULN
2. Total bilirubin >1.5 x ULN
3. Serum albumin <3.5 g/dL
4. International normalized ratio >1.2
5. Platelet count <140 k/mm3
6. Hemoglobin <12.0 g/dL for males and <11.0 g/dL for females
7. White blood cell count <3.0 k/mm3
8. Serum creatinine >1.1 x ULN
9. Urine protein/creatinine ratio ≥0.2 mg/mg. In the event of a ratio above this
threshold, eligibility may be confirmed by a quantitative total urine protein
measurement of <150 mg/24 hour
10. Positive test (including trace) for blood on urinalysis. In the event of a
positive test, eligibility may be confirmed with urine microscopy showing <5 red
blood cells per high power field
9. Clinically significant abnormalities aside from chronic HBV infection in medical
history (e.g., previous acute coronary syndrome within 6 months of screening, major
surgery within 3 months of screening, uncontrolled diabetes) or physical examination.
10. History of bleeding diathesis or coagulopathy.
11. History of extrahepatic disorders possibly related to HBV immune complexes (e.g.,
glomerulonephritis, polyarteritis nodosa) .
12. Active infection other than HBV, requiring systemic antiviral or antimicrobial therapy
that will not be completed prior to Study Day 1.