Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04485663
Registration number
NCT04485663
Ethics application status
Date submitted
9/07/2020
Date registered
24/07/2020
Date last updated
15/03/2022
Titles & IDs
Public title
A Study of ALG-010133 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects
Query!
Scientific title
A Phase 1, Double-blind, Randomized, Placebo-controlled, First-in-human Study of Subcutaneously Administered ALG-010133 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Ascending Doses (Part 1) and Multiple Ascending Doses in Healthy Volunteers (Part 2), and Multiple Doses in Subjects With Chronic Hepatitis B (Part 3)
Query!
Secondary ID [1]
0
0
ALG-010133-101
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B
0
0
Query!
Condition category
Condition code
Infection
0
0
0
0
Query!
Other infectious diseases
Query!
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - ALG-010133
Treatment: Drugs - Placebo
Experimental: ALG-010133 - Subcutaneous injections of ALG-010133 in HV or CHB subjects up to every 7 days for up to 12 weeks
Placebo Comparator: Placebo - Subcutaneous injections of placebo in HV or CHB subjects up to every 7 days for up to 12 weeks
Treatment: Drugs: ALG-010133
Single or multiple doses of ALG-010133
Treatment: Drugs: Placebo
Single or multiple doses of Placebo
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Query!
Assessment method [1]
0
0
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Query!
Timepoint [1]
0
0
up to 15 days for Part 1
Query!
Primary outcome [2]
0
0
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Query!
Assessment method [2]
0
0
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Query!
Timepoint [2]
0
0
up to 29 days for Part 2
Query!
Primary outcome [3]
0
0
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Query!
Assessment method [3]
0
0
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Query!
Timepoint [3]
0
0
up to 162 days for Part 3
Query!
Secondary outcome [1]
0
0
Maximum Plasma Concentration [Cmax]
Query!
Assessment method [1]
0
0
Pharmacokinetic parameters of ALG-010133 in plasma
Query!
Timepoint [1]
0
0
Predose (0 hours) up to 162 Days (3864 hours)
Query!
Secondary outcome [2]
0
0
Area under the concentration time curve [AUC]
Query!
Assessment method [2]
0
0
Pharmacokinetic parameters of ALG-010133 in plasma
Query!
Timepoint [2]
0
0
Predose (0 hours) up to 162 Days (3864 hours)
Query!
Secondary outcome [3]
0
0
Time to maximum plasma concentration [Tmax]
Query!
Assessment method [3]
0
0
Pharmacokinetic parameters of ALG-010133 in plasma
Query!
Timepoint [3]
0
0
Predose (0 hours) up to 162 Days (3864 hours)
Query!
Secondary outcome [4]
0
0
Half-time [t1/2]
Query!
Assessment method [4]
0
0
Pharmacokinetic parameters of ALG-010133 in plasma
Query!
Timepoint [4]
0
0
Predose (0 hours) up to 162 Days (3864 hours)
Query!
Secondary outcome [5]
0
0
Minimum Plasma Concentration [Cmin]
Query!
Assessment method [5]
0
0
Pharmacokinetic parameters of ALG-010133 in plasma
Query!
Timepoint [5]
0
0
Predose (0 hours) up to 162 Days (3864 hours)
Query!
Secondary outcome [6]
0
0
Change in HBsAg (reduction) from baseline through Day 78 in Multiple Dose HBV Infected Patients
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
Screening, Day -1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78
Query!
Eligibility
Key inclusion criteria
Inclusion Criteria for Healthy Subjects:
1. Male and Female between 18 and 55 years old
2. Female subjects must have a negative serum pregnancy test at screening
3. Subjects must be nonsmokers for at least 3 months prior to randomization
4. BMI 18.0 to 32.0 kg/m^2
5. Subjects must have a 12-lead ECG that meets protocol criteria
Inclusion Criteria for CHB Subjects:
1. Male and Female between 18 and 70 years old
2. Female subjects must have a negative serum pregnancy test at screening
3. BMI 18.0 to 35.0 kg/m^2
4. HBeAg-negative chronic hepatitis B or HBeAg-positive chronic hepatitis B and are
currently receiving HBV NA treatment for =6 months prior to screening
5. Subjects must have a 12-lead ECG that meets protocol criteria
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
70
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
Exclusion Criteria for Healthy 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 units/week for women
and =21 units/week for men
6. Unwilling to abstain from alcohol use for 48 hours prior to start of dosing through
end of study follow up
7. Subjects with Hepatitis A, B, C, D, E or HIV-1/HIV-2 infection or acute infections
such as SARS- CoV-2 infection
8. Subjects with renal dysfunction (e.g., estimated creatinine clearance <90 mL/min/1.73
m^2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration
[CKD-EPI] formula)
Exclusion Criteria for CHB 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 units/week for women
and =21 units/week for men
6. Subjects with Hepatitis A, C, D, E or HIV-1/HIV-2 infection or acute infections such
as SARS- CoV-2 infection
7. Subjects with renal dysfunction (e.g., estimated creatinine clearance <90 mL/min/1.73
m^2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration
[CKD-EPI] formula)
8. 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)
9. Subjects must have absence of signs of hepatocellular carcinoma
10. Subjects with history or current liver cirrhosis
11. Subjects positive for anti-HBs anitbodies
12. Subjects with liver fibrosis that is classified as Metavir Score =F3
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Terminated
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
17/08/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
8/03/2022
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
103
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
China
Query!
State/province [1]
0
0
Guangdong
Query!
Country [2]
0
0
China
Query!
State/province [2]
0
0
Jilin
Query!
Country [3]
0
0
Hong Kong
Query!
State/province [3]
0
0
Hong Kong
Query!
Country [4]
0
0
Korea, Republic of
Query!
State/province [4]
0
0
Busan
Query!
Country [5]
0
0
Korea, Republic of
Query!
State/province [5]
0
0
Seoul
Query!
Country [6]
0
0
Moldova, Republic of
Query!
State/province [6]
0
0
Chisinau
Query!
Country [7]
0
0
New Zealand
Query!
State/province [7]
0
0
Auckland
Query!
Country [8]
0
0
United Kingdom
Query!
State/province [8]
0
0
London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Aligos Therapeutics
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
A Randomized Study of ALG-010133 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and
Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04485663
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04485663
Download to PDF