Chronic Hepatitis BPhase 1NCT04485663
A Study of ALG-010133 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects
A Phase 1 study testing ALG-010133 in people with Chronic Hepatitis B, run by Aligos Therapeutics at 10 sites in 6 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- ALG-010133
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 10 sitesin 6 countries
- Study dates
- 17 Aug 2020to 8 Mar 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and Female between 18 and 55 years old
- Female subjects must have a negative serum pregnancy test at screening
- Subjects must be nonsmokers for at least 3 months prior to randomization
- BMI 18.0 to 32.0 kg/m^2
- Subjects must have a 12-lead ECG that meets protocol criteria
- Male and Female between 18 and 70 years old
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- Female subjects must have a negative serum pregnancy test at screening
- BMI 18.0 to 35.0 kg/m^2
- HBeAg-negative chronic hepatitis B or HBeAg-positive chronic hepatitis B and are currently receiving HBV NA treatment for ≥6 months prior to screening
- Subjects must have a 12-lead ECG that meets protocol criteria
Who cannot join
- 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
- 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.
- Subjects with a history of clinically significant drug allergy
- Subject with current or history of clinically significant (as determined by the Investigator) skin disease requiring intermittent or chronic treatment
- Excessive use of alcohol defined as regular consumption of ≥14 units/week for women and ≥21 units/week for men
- Unwilling to abstain from alcohol use for 48 hours prior to start of dosing through end of study follow up
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- Subjects with Hepatitis A, B, C, D, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
- 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)
- 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
- 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.
- Subjects with a history of clinically significant drug allergy
- Subject with current or history of clinically significant (as determined by the Investigator) skin disease requiring intermittent or chronic treatment
- Excessive use of alcohol defined as regular consumption of ≥14 units/week for women and ≥21 units/week for men
- Subjects with Hepatitis A, C, D, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
- 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)
- 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)
- Subjects must have absence of signs of hepatocellular carcinoma
- Subjects with history or current liver cirrhosis
- Subjects positive for anti-HBs anitbodies
- Subjects with liver fibrosis that is classified as Metavir Score ≥F3
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
South Korea4 sites
Pusan National University Hospital
Busan
Asan Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
China2 sites
The First Hospital of Jilin University
Changchun, Jilin, 130021
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong
Moldova1 site
PMSI Republican Clinical Hospital "T. Mosneaga", ARENSIA Exploratory Medicine Phase I Unit
Chisinau
About this study
Official 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)
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
- Conditions
- Chronic Hepatitis B
- Being tested
- ALG-010133, Placebo
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALG-010133Drug
Single or multiple doses of ALG-010133
PlaceboDrug
Single or multiple doses of Placebo
| Study group | Role | What they receive |
|---|---|---|
| ALG-010133 | Experimental | Subcutaneous injections of ALG-010133 in HV or CHB subjects up to every 7 days for up to 12 weeks Receives: Drug: ALG-010133 |
| Placebo | Placebo comparator | Subcutaneous injections of placebo in HV or CHB subjects up to every 7 days for up to 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Measured: up to 15 days for Part 1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Measured: up to 29 days for Part 2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Measured: up to 162 days for Part 3
Secondary outcomes (6)
Maximum Plasma Concentration [Cmax]
Pharmacokinetic parameters of ALG-010133 in plasma
Measured: Predose (0 hours) up to 162 Days (3864 hours)
Area under the concentration time curve [AUC]
Pharmacokinetic parameters of ALG-010133 in plasma
Measured: Predose (0 hours) up to 162 Days (3864 hours)
Time to maximum plasma concentration [Tmax]
Pharmacokinetic parameters of ALG-010133 in plasma
Measured: Predose (0 hours) up to 162 Days (3864 hours)
Half-time [t1/2]
Pharmacokinetic parameters of ALG-010133 in plasma
Measured: Predose (0 hours) up to 162 Days (3864 hours)
Minimum Plasma Concentration [Cmin]
Pharmacokinetic parameters of ALG-010133 in plasma
Measured: Predose (0 hours) up to 162 Days (3864 hours)
Change in HBsAg (reduction) from baseline through Day 78 in Multiple Dose HBV Infected Patients
Measured: Screening, Day -1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start17 Aug 2020
- Primary completion8 Mar 2022
- Study completion8 Mar 2022
Why it stopped: Lack of antiviral activity at the projected efficacious dose.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aligos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485663
- Sponsor's protocol ID
- ALG-010133-101
- Status last verified
- Mar 2022
- First submitted
- 9 Jul 2020
- Last updated
- 15 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT04485663
- Acronym / sponsor ID
- ALG-010133-101
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of antiviral activity at the projected efficacious dose.
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Aligos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 8 Mar 2022 (actual)
- Study completion
- 8 Mar 2022 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALG-010133 | Experimental | Drug: ALG-010133Subcutaneous injections of ALG-010133 in HV or CHB subjects up to every 7 days for up to 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboSubcutaneous injections of placebo in HV or CHB subjects up to every 7 days for up to 12 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and Female between 18 and 55 years old
- Female subjects must have a negative serum pregnancy test at screening
- Subjects must be nonsmokers for at least 3 months prior to randomization
- BMI 18.0 to 32.0 kg/m^2
- Subjects must have a 12-lead ECG that meets protocol criteria
Key exclusion criteria (20 listed)
- 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
- 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.
- Subjects with a history of clinically significant drug allergy
- Subject with current or history of clinically significant (as determined by the Investigator) skin disease requiring intermittent or chronic treatment
- Excessive use of alcohol defined as regular consumption of ≥14 units/week for women and ≥21 units/week for men
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALG-010133Single or multiple doses of ALG-010133 | Drug | ALG-010133 |
| PlaceboSingle or multiple doses of Placebo | Drug | Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: up to 15 days for Part 1
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: up to 29 days for Part 2
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: up to 162 days for Part 3
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
6 secondary outcomes
Maximum Plasma Concentration [Cmax]
Time frame: Predose (0 hours) up to 162 Days (3864 hours)
Area under the concentration time curve [AUC]
Time frame: Predose (0 hours) up to 162 Days (3864 hours)
Time to maximum plasma concentration [Tmax]
Time frame: Predose (0 hours) up to 162 Days (3864 hours)
Half-time [t1/2]
Time frame: Predose (0 hours) up to 162 Days (3864 hours)
Minimum Plasma Concentration [Cmin]
Time frame: Predose (0 hours) up to 162 Days (3864 hours)
Change in HBsAg (reduction) from baseline through Day 78 in Multiple Dose HBV Infected Patients
Time frame: Screening, Day -1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78
Results and safety
The study was stopped early (reason given: Lack of antiviral activity at the projected efficacious dose.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALG-010133 in people with Chronic Hepatitis B, run by Aligos Therapeutics at 10 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea, China, Hong Kong, Moldova, New Zealand and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of antiviral activity at the projected efficacious dose.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: up to 15 days for Part 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.