Chronic Hepatitis BPhase 1NCT05561530
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
A Phase 1 study testing ALG-125755 in people with Chronic Hepatitis B, run by Aligos Therapeutics at 4 sites in 4 countries.
Trial 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 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-125755
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 7 Oct 2022to 15 Jun 2023
- 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
- Female subjects must have a negative serum pregnancy test at screening
- Subjects must have a 12-lead electrocardiogram (ECG) that meets the protocol criteria
- Male or female between 18 and 55 years of age, extremes included.
- Subjects must have a body mass index (BMI) of 18.0 to 32.0 kg/m2, extremes included.
- Subjects must be 18 to 70 years of age, inclusive of extremes.
- Subjects may have a BMI of 18.0 to 35.0 kg/m2, extremes included.
- 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
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 standard drinks/week for women and ≥21 standard drinks/week for men
Show all 14Show fewer
- Subjects with Hepatitis A, B, C, D, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
- Unwilling to abstain from alcohol use for 48 hours prior to start of study through end of study follow up.
- 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]
- Subjects who are positive for anti-HBs antibodies.
- 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).
- History or current evidence of cirrhosis.
- Subjects with liver fibrosis that is classified as Metavir Score ≥F3 liver disease
- Subjects must have absence of signs of hepatocellular carcinoma
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Bulgaria1 site
MBAL Sveta Sofia EOOD, Dept of Internal Medicine with Gastroenterology Section
Sofia
Moldova1 site
PMSI Republican Clinical Hospital "t. Mosneaga", ARENSIA Exploratory Medicine Phase 1 Unit
Chisinau
Romania1 site
National Institute for Infection Diseases, ARENSIA Exploratory Medicine S.R.L.
Bucharest
About this study
Official 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)
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
- Conditions
- Chronic Hepatitis B
- Being tested
- ALG-125755, 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-125755Drug
single or multiple doses of ALG-125755
PlaceboDrug
single or multiple doses of placebo
| Study group | Role | What they receive |
|---|---|---|
| ALG-125755 | Experimental | Subcutaneous injections of ALG-125755 in HV or CHB subjects, up to 6 injections over the course of up to 72 weeks Receives: Drug: ALG-125755 |
| Placebo | Placebo comparator | Subcutaneous injections of placebo in HV or CHB subjects, up to 6 injections over the course of up to 72 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 32 days for Part 1
Incidence and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Measured: Up to 52 days for Part 2
Incidence and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Measured: Up to 616 days for Part 3
Secondary outcomes (6)
Maximum plasma concentration (Cmax)
Pharmacokinetic parameters of ALG-125755 in plasma
Measured: Predose (0 hours) up to 616 days
Area under the concentration time curve [AUC]
Pharmacokinetic parameters of ALG-125755 in plasma
Measured: Predose (0 hours) up to 616 days
Time to maximum plasma concentration [Tmax]
Pharmacokinetic parameters of ALG-125755 in plasma
Measured: Predose (0 hours) up to 616 days
Antiviral activity of ALG-125755 as measured by quantitative changes in serum
Pharmacokinetic parameters of ALG-125755 in plasma
Measured: Predose (0 hours) up to 616 days
Minimum plasma concentration (Cmin)
Pharmacokinetic parameters of ALG-125755 in plasma
Measured: Predose (0 hours) up to 616 days
Change in HBsAg from baseline through up to 112 days from last dose in multiple dose HBV infected subjects
Measured: screening to up to 112 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start7 Oct 2022
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Why it stopped: Single doses demonstrated an acceptable safety profile and antiviral activity at all doses evaluated.
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
- 57 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
- NCT05561530
- Sponsor's protocol ID
- ALG-125755-501
- Status last verified
- Mar 2024
- First submitted
- 26 Sep 2022
- Last updated
- 15 Mar 2024
- 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 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT05561530
- Acronym / sponsor ID
- ALG-125755-501
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Single doses demonstrated an acceptable safety profile and antiviral activity at all doses evaluated.
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Aligos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 30 Sep 2022 (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-125755 to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics after single doses in healthy volunteers, and single and multiple doses in 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-125755 | Experimental | Drug: ALG-125755Subcutaneous injections of ALG-125755 in HV or CHB subjects, up to 6 injections over the course of up to 72 weeks |
| Placebo | Placebo comparator | Drug: PlaceboSubcutaneous injections of placebo in HV or CHB subjects, up to 6 injections over the course of up to 72 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female subjects must have a negative serum pregnancy test at screening
- Subjects must have a 12-lead electrocardiogram (ECG) that meets the protocol criteria
- Male or female between 18 and 55 years of age, extremes included.
- Subjects must have a body mass index (BMI) of 18.0 to 32.0 kg/m2, extremes included.
- Subjects must be 18 to 70 years of age, inclusive of extremes.
Key exclusion criteria (14 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
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-125755single or multiple doses of ALG-125755 | Drug | ALG-125755 |
| Placebosingle or multiple doses of placebo | Drug | Placebo |
Primary outcome
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
Time frame: Up to 32 days for Part 1
Incidence and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Time frame: Up to 52 days for Part 2
Incidence and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Time frame: Up to 616 days for Part 3
6 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: Predose (0 hours) up to 616 days
Area under the concentration time curve [AUC]
Time frame: Predose (0 hours) up to 616 days
Time to maximum plasma concentration [Tmax]
Time frame: Predose (0 hours) up to 616 days
Antiviral activity of ALG-125755 as measured by quantitative changes in serum
Time frame: Predose (0 hours) up to 616 days
Minimum plasma concentration (Cmin)
Time frame: Predose (0 hours) up to 616 days
Change in HBsAg from baseline through up to 112 days from last dose in multiple dose HBV infected subjects
Time frame: screening to up to 112 days
Results and safety
The study was stopped early (reason given: Single doses demonstrated an acceptable safety profile and antiviral activity at all doses evaluated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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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.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALG-125755 in people with Chronic Hepatitis B, run by Aligos Therapeutics at 4 sites in 4 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 7 inclusion and 14 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 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Bulgaria, Moldova, New Zealand, Romania. 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: Single doses demonstrated an acceptable safety profile and antiviral activity at all doses evaluated.). 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 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 (time frame: Up to 32 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 2024.