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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05561530




Registration number
NCT05561530
Ethics application status
Date submitted
26/09/2022
Date registered
30/09/2022
Date last updated
15/03/2024

Titles & IDs
Public title
A Study of ALG-125755 to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Single Doses in Healthy Volunteers, and Single and Multiple Doses in CHB Subjects
Scientific title
A Phase 1/1b, Double-Blind, Randomized, Placebo-Controlled, First-in-Human Study of Subcutaneously Administered ALG-125755 to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Single Ascending Doses in Healthy Volunteers (Part 1) and Subjects With Chronic Hepatitis B (Part 2), and Multiple Doses in Subjects With Chronic Hepatitis B (Part 3)
Secondary ID [1] 0 0
ALG-125755-501
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 - ALG-125755
Treatment: Drugs - Placebo

Experimental: ALG-125755 - Subcutaneous injections of ALG-125755 in HV or CHB subjects, up to 6 injections over the course of up to 72 weeks

Placebo comparator: Placebo - Subcutaneous injections of placebo in HV or CHB subjects, up to 6 injections over the course of up to 72 weeks


Treatment: Drugs: ALG-125755
single or multiple doses of ALG-125755

Treatment: Drugs: Placebo
single or multiple doses of placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and severity of treatment emergent adverse events as assessed by DAIDS v2.1 of various doses of ALG-125755 in HV subjects and CHB subjects
Timepoint [1] 0 0
Up to 32 days for Part 1
Primary outcome [2] 0 0
Incidence and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Timepoint [2] 0 0
Up to 52 days for Part 2
Primary outcome [3] 0 0
Incidence and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Timepoint [3] 0 0
Up to 616 days for Part 3
Secondary outcome [1] 0 0
Maximum plasma concentration (Cmax)
Timepoint [1] 0 0
Predose (0 hours) up to 616 days
Secondary outcome [2] 0 0
Area under the concentration time curve [AUC]
Timepoint [2] 0 0
Predose (0 hours) up to 616 days
Secondary outcome [3] 0 0
Time to maximum plasma concentration [Tmax]
Timepoint [3] 0 0
Predose (0 hours) up to 616 days
Secondary outcome [4] 0 0
Antiviral activity of ALG-125755 as measured by quantitative changes in serum
Timepoint [4] 0 0
Predose (0 hours) up to 616 days
Secondary outcome [5] 0 0
Minimum plasma concentration (Cmin)
Timepoint [5] 0 0
Predose (0 hours) up to 616 days
Secondary outcome [6] 0 0
Change in HBsAg from baseline through up to 112 days from last dose in multiple dose HBV infected subjects
Timepoint [6] 0 0
screening to up to 112 days

Eligibility
Key inclusion criteria
Inclusion Criteria for All Subjects:

1. Female subjects must have a negative serum pregnancy test at screening
2. Subjects must have a 12-lead electrocardiogram (ECG) that meets the protocol criteria

Inclusion Criteria for Healthy Subjects:

1. Male or female between 18 and 55 years of age, extremes included.
2. Subjects must have a body mass index (BMI) of 18.0 to 32.0 kg/m2, extremes included.

Inclusion Criteria for CHB Subjects (Parts 2 and 3):

1. Subjects must be 18 to 70 years of age, inclusive of extremes.
2. Subjects may have a BMI of 18.0 to 35.0 kg/m2, extremes included.
3. For virally suppressed subjects, must be currently receiving HBV NA treatment for =6 months prior to screening. For currently not treated or treatment naïve subjects, must have never received treatment OR have not been on treatment within 6 months prior to randomization
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria for All Subjects:

1. Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation
2. Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or history or clinical evidence at screening of significant or unstable cardiac disease etc.
3. Subjects with a history of clinically significant drug allergy
4. Subject with current or history of clinically significant (as determined by the Investigator) skin disease requiring intermittent or chronic treatment
5. Excessive use of alcohol defined as regular consumption of

=14 standard drinks/week for women and =21 standard drinks/week for men
6. Subjects with Hepatitis A, B, C, D, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection

Exclusion Criteria for Healthy Volunteers (Part 1):

1. Unwilling to abstain from alcohol use for 48 hours prior to start of study through end of study follow up.
2. Subjects with renal dysfunction [e.g., estimated creatinine clearance <90 mL/min/1.73 m2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula]

Exclusion criteria for CHB subjects (Parts 2 and 3):

1. Subjects who are positive for anti-HBs antibodies.
2. Subject with any history or current evidence of hepatic decompensation such as: variceal bleeding, spontaneous bacterial peritonitis, ascites, hepatic encephalopathy, or active jaundice (within the last year).
3. History or current evidence of cirrhosis.
4. Subjects with liver fibrosis that is classified as Metavir Score =F3 liver disease
5. Subjects must have absence of signs of hepatocellular carcinoma

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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/06/2023
Sample size
Target
Accrual to date
Final
57
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Bulgaria
State/province [1] 0 0
Sofia
Country [2] 0 0
Moldova, Republic of
State/province [2] 0 0
Chisinau
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
Romania
State/province [4] 0 0
Bucharest

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Aligos Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A randomized study of ALG-125755 to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics after single doses in healthy volunteers, and single and multiple doses in CHB subjects
Trial website
https://clinicaltrials.gov/study/NCT05561530
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05561530