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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05717686




Registration number
NCT05717686
Ethics application status
Date submitted
20/01/2023
Date registered
8/02/2023

Titles & IDs
Public title
A Study Evaluating AHB-137 in Healthy Participants and Participants With Chronic Hepatitis B
Scientific title
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AHB-137 With Single Ascending Doses and Multiple Doses in Healthy Volunteers and Initial Efficacy in Chronic Hepatitis B Patients
Secondary ID [1] 0 0
AB-10-8001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AHB-137 injection
Treatment: Drugs - Placebo

Experimental: Part A: SAD in healthy participants - Part A: Single ascending doses of up to 450 mg AHB-137 by subcutaneous (SC) injection in healthy participants.

Experimental: Part B: MD in healthy participants - Part B: Multiple doses of 300 mg AHB-137 by subcutaneous (SC) injection in healthy participants.

Experimental: Part C: MD in CHB patients (open label) - Part C: Multiple doses of 300 mg AHB-137 by subcutaneous (SC) injection in CHB patients.

Experimental: Part D: MD in CHB patients in multiple centers - Part D: Multiple doses of 200 mg or 300 mg AHB-137 by subcutaneous (SC) injection in CHB patients (Multiple centers across multiple regions).


Treatment: Drugs: AHB-137 injection
AHB-137 will be administered

Treatment: Drugs: Placebo
Placebo will be administered
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Participants With Treatment-Emergent Adverse Events (TEAEs) in Healthy Volunteers
Timepoint [1] 0 0
Up to 30 days for SAD, up to 113 days for MD
Primary outcome [2] 0 0
Proportion of Participants With Treatment-Emergent Adverse Events (TEAEs) in CHB patients
Timepoint [2] 0 0
Up to 204 days for MD
Secondary outcome [1] 0 0
The anti-HBV efficacy of AHB-137: evaluate the change in serum HBsAg (log10 IU/mL) from baseline.
Timepoint [1] 0 0
Up to 204 days
Secondary outcome [2] 0 0
The anti-HBV efficacy of AHB-137: evaluate the expression of HBsAb in serum.
Timepoint [2] 0 0
Up to 204 days
Secondary outcome [3] 0 0
The pharmacokinetic profile of AHB-137: the maximum observed plasma concentration (Cmax) of AHB-137
Timepoint [3] 0 0
Up to 30 days for SAD; up to 204 days for MD
Secondary outcome [4] 0 0
The pharmacokinetic profile of AHB-137: time of observed maximal concentration (Tmax) of AHB-137
Timepoint [4] 0 0
Up to 30 days for SAD; up to 204 days for MD
Secondary outcome [5] 0 0
The pharmacokinetic profile of AHB-137: areas under the concentration time curve (AUC) of AHB-137
Timepoint [5] 0 0
Up to 30 days for SAD; up to 204 days for MD
Secondary outcome [6] 0 0
The pharmacokinetic profile of AHB-137: mean residence time (MRT) of AHB-137
Timepoint [6] 0 0
Up to 30 days for SAD; up to 204 days for MD
Secondary outcome [7] 0 0
The pharmacokinetic profile of AHB-137: terminal half-life (t1/2) of AHB-137
Timepoint [7] 0 0
Up to 30 days for SAD; up to 204 days for MD
Secondary outcome [8] 0 0
The pharmacokinetic profile of AHB-137: apparent subcutaneous plasma clearance (CL/F) of AHB-137
Timepoint [8] 0 0
Up to 30 days for SAD; up to 204 days for MD
Secondary outcome [9] 0 0
The pharmacokinetic profile of AHB-137: amount of AHB-137 excreted in urine (Ae)
Timepoint [9] 0 0
Day 1-4 for SAD; Day 1-4 and Day 22-25 for MD
Secondary outcome [10] 0 0
The pharmacokinetic profile of AHB-137: renal clearance (CLr) of AHB-137
Timepoint [10] 0 0
Day 1-4 for SAD; Day 1-4 and Day 22-25 for MD

Eligibility
Key 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. Participants' COVID-19 PCR test should be negative during screening.
4. 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 for CHB patients recruited to Part C; ALT = 2 ULN for CHB patients recruited to Part D.
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. CHB patients participating in Part D should have been on commercially available HBV OAV treatment(s) for at least 6 months with no change in regimen for 3 months prior to screening. HBV DNA under limit of quantification (LOQ) at Screening.
6. Both HBeAg positive and negative CHB patients can be recruited to Part C of the study. Only HBeAg negative CHB patients can be recruited to Part D of the study.
7. COVID-19 RAT test should be negative at check-in.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Healthy participants are required to not meet any of the following 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 = 60 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 following 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 > 5 x ULN for Part C or > 2 x ULN for Part D
2. Total bilirubin > 1.25 x ULN
3. Serum albumin < 3.4 g/dL
4. International normalized ratio of prothrombin time > 1.25
5. Platelet count <140 x 10^9/L
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 and/or poorly controlled medical conditions (e.g. Cardiovascular, pulmonary, metabolic disease) in the opinion of the investigator.
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Hong Kong
State/province [5] 0 0
Hong Kong
Country [6] 0 0
New Zealand
State/province [6] 0 0
Auckland
Country [7] 0 0
Taiwan
State/province [7] 0 0
Chiayi City
Country [8] 0 0
Taiwan
State/province [8] 0 0
Kaohsiung

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AusperBio Therapeutics Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ed Gane
Address 0 0
University of Auckland, New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05717686