Chronic Hepatitis BPhase 1NCT05310487
Phase 1 Study of 162, a Novel Neutralizing Antibody Targeting Hepatitis B Surface Antigen, in Healthy Adult Subjects
A Phase 1 study testing 162 in people with Chronic Hepatitis B, run by Yangshengtang Co., Ltd at 1 site in Australia.
Trial summary
This is the first in human study of 162, and the primary objective is to evaluate the safety and tolerability of 162 with a single ascending dose in healthy adult subjects. The dose-escalation stage will be conducted sequentially at 5 dose levels, which are 100 mg in the pre-test, and 200 mg, 400 mg, 800 mg and 1200… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- 162
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- 30 Sep 2022to 22 Oct 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteer to participate in the study, be able to understand the requirements of a clinical study, and sign informed consent form.
- Aged ≥ 18 and ≤ 55 years older, male and female.
- Body weight ≥ 50 kg for male, body weight ≥ 45 kg for female, and body mass index (BMI) scores between ≥ 18 kg/m2 and ≤ 32.0 kg/m2.
- Vital signs, physical examination, laboratory tests and 12-lead ECG, etc. within normal limits; or, with no clinically significant abnormalities as determined by the investigator.
- A male participant must agree to use adequate contraception from screening through at least 12 weeks after the last dose of investigational product or placebo. Refer to Section 5.5 for more information on highly effective methods of contraception.
- Women of childbearing potential must have a negative pregnancy test prior to the dosing administration, and agree to use adequate contraception from screening through at least 12 weeks after the last dose of investigational product or placebo. A female participant of non-childbearing potential will have had at least 12 continuous months of natural (spontaneous) amenorrhoea, follicle stimulating hormone (FSH) level > 40 mIU/mL at screening, and an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms); or have had surgical bilateral oophorectomy, hysterectomy or tubal ligation beyond 6 weeks prior to screening. Refer to Section 5.5 for more information on highly effective methods of contraception
Who cannot join
- History of anaphylaxis or clinically significant drug allergy or drug allergy witnessed in previous studies with experimental drugs, or allergy to the active ingredients or excipients of the investigational product.
- History of allergic reactions to monoclonal antibodies or antibody fragments.
- History or presence of infectious or non-infectious liver disease, including but not limited to a history of alcoholic liver disease, non-alcoholic steatohepatitis, drug or autoimmune liver disease.
- History or presence of immune-mediated diseases, including but not limited to idiopathic thrombocytopenic purpura, systemic lupus erythematosus, rheumatoid arthritis.
- History or presence of any chronic infectious condition, including but not limited to tuberculosis or parasitic infections.
- History of allogenic transplantation of organs, bone marrow or stem cell.
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- Active infection, or screening for infectious disease during the screening period (HBsAg, hepatitis C virus antibody [HCV-Ab], human immunodeficiency virus antibody [HIV-Ab], or syphilis antibody [TP-Ab]) is positive.
- QTcF >450 msec on 3 consecutive ECG recordings conducted at screening or baseline.
- Alanine transaminase (ALT) > 1.2 × ULN, aspartate aminotransferase (AST) > 1.2 × ULN or total bilirubin > 1.2 × ULN.
- Any other concomitant disease, condition or treatment that could interfere with the conduct of the study or that would, in the opinion of the Investigator or Sponsor, pose an unacceptable risk to the subject in the study or interfere with the interpretation of study data.
- Took any prescription drugs or over-the-counter drugs within 2 weeks prior to investigational product or placebo administration, or took any drugs within 5 half-lives at the time of investigational product or placebo administration (whichever is longer), but vitamins, supplements and topical corticosteroids will be permitted within 2 weeks prior to investigational product or placebo administration; or, took any herbal medicines within 30 days before investigational product or placebo administration.
- Those who have received live or attenuated vaccines (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, BCG, typhoid vaccine, etc.) within 4 weeks before screening, or any covid-19 vaccine within 2 weeks before screening.
- Those who donated plasma within 7 days prior to the dosing administration or donated or lost blood 500 mL or more within 8 weeks prior to the dosing administration, or plan to donate during the study or within 8 weeks after the end of the study.
- Those who underwent surgery within 4 weeks before screening, or plan to undergo surgery during the study.
- Those who are participating in other clinical studies, or currently not participating in a study and have been dosed in another clinical study in the past 4 weeks.
- Pregnant or lactating women.
- Those who are determined disqualified to join clinical studies by investigator for other causes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics of 162 With a Single Ascending Dose in Healthy Adult Subjects
This is the first in human study of 162, and the primary objective is to evaluate the safety and tolerability of 162 with a single ascending dose in healthy adult subjects.
The dose-escalation stage will be conducted sequentially at 5 dose levels, which are 100 mg in the pre-test, and 200 mg, 400 mg, 800 mg and 1200 mg in the formal test.
Two healthy adult subjects will be enrolled at 100 mg dose level and all given 162. Eight healthy adult subjects will be enrolled at each remaining dose levels (200 mg, 400 mg, 800 mg and 1200 mg), respectively.
- Conditions
- Chronic Hepatitis B
- Being tested
- 162, 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.
162Biological
The investigational product 162 is a novel neutralizing antibody targeting HBsAg, for the treatment of patients with chronic hepatitis B
PlaceboOther
an intervention that appearance is the same as 162, but contains no active ingredients
| Study group | Role | What they receive |
|---|---|---|
| 162 | Experimental | The dose-escalation stage will be conducted sequentially at 5 dose levels, which are 100 mg in the pre-test, and 200 mg, 400 mg, 800 mg and 1200 mg in the formal test. Two healthy adult subjects will be enrolled at 100 mg dose level and all given 162. At the start of each level with the exception of 100 mg level which there are only two subjects, two sentinel subjects will be randomized 1:1 to 162 or placebo. The remaining subjects will be randomized 5:1 to receive a single ascending dose of 162 or placebo. Receives: Biological: 162 |
| placebo | Placebo comparator | At the start of each level with the exception of 100 mg level which there are only two subjects, two sentinel subjects will be randomized 1:1 to 162 or placebo. The remaining subjects will be randomized 5:1 to receive a single ascending dose of 162 or placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
incidence and severity of adverse events after the administrtion of 162 or placebo
Measured: Day 1-Day 28
Secondary outcomes (7)
Peak Plasma Concentration (Cmax)
Maximum concentration of 162 in blood after administration
Measured: Day 1-Day 28
Area under the plasma concentration versus time curve from time 0 to the last test time(AUC last)
Area under the plasma concentration of 162 versus time curve from time 0 to the last test time
Measured: Day 1-Day 28
Area under the plasma concentration versus time curve from time 0 to infinity time(AUC 0-∞)
Area under the plasma concentration of 162 versus time curve from time 0 to infinity time
Measured: Day 1-Day 28
Half life (t1/2)
The elimination half-life time of 162 in blood
Measured: Day 1-Day 28
Clearance (Cl)
Clearance of 162 in blood
Measured: Day 1-Day 28
Apparent volume of distribution (Vd)
The apparent volume of distribution of 162 in vitro
Measured: Day 1-Day 28
Immunogenicity
To evaluate the level of anti-drug antibody (ADA) produced by the subjects.
Measured: Day 1-Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start30 Sep 2022
- Primary completion3 Oct 2023
- Study completion22 Oct 2023
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yangshengtang Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310487
- Sponsor's protocol ID
- YST-162-101
- Status last verified
- Jul 2023
- First submitted
- 23 Mar 2022
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics of 162 With a Single Ascending Dose in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05310487
- Acronym / sponsor ID
- YST-162-101
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yangshengtang Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 3 Oct 2023 (actual)
- Study completion
- 22 Oct 2023 (actual)
- First posted
- 5 Apr 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.
This is the first in human study of 162, and the primary objective is to evaluate the safety and tolerability of 162 with a single ascending dose in healthy adult subjects.
The dose-escalation stage will be conducted sequentially at 5 dose levels, which are 100 mg in the pre-test, and 200 mg, 400 mg, 800 mg and 1200 mg in the formal test.
Two healthy adult subjects will be enrolled at 100 mg dose level and all given 162. Eight healthy adult subjects will be enrolled at each remaining dose levels (200 mg, 400 mg, 800 mg and 1200 mg), respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 162 | Experimental | Biological: 162The dose-escalation stage will be conducted sequentially at 5 dose levels, which are 100 mg in the pre-test, and 200 mg, 400 mg, 800 mg and 1200 mg in the formal test. Two healthy adult subjects will be enrolled at 100 mg dose level and all given 162. At the start of each level with the exception of 100 mg level which there are only two subjects, two sentinel subjects will be randomized 1:1 to 162 or placebo. The remaining subjects will be randomized 5:1 to receive a single ascending dose of 162 or placebo. |
| placebo | Placebo comparator | Other: PlaceboAt the start of each level with the exception of 100 mg level which there are only two subjects, two sentinel subjects will be randomized 1:1 to 162 or placebo. The remaining subjects will be randomized 5:1 to receive a single ascending dose of 162 or placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Volunteer to participate in the study, be able to understand the requirements of a clinical study, and sign informed consent form.
- Aged ≥ 18 and ≤ 55 years older, male and female.
- Body weight ≥ 50 kg for male, body weight ≥ 45 kg for female, and body mass index (BMI) scores between ≥ 18 kg/m2 and ≤ 32.0 kg/m2.
- Vital signs, physical examination, laboratory tests and 12-lead ECG, etc. within normal limits; or, with no clinically significant abnormalities as determined by the investigator.
- A male participant must agree to use adequate contraception from screening through at least 12 weeks after the last dose of investigational product or placebo. Refer to Section 5.5 for more information on highly effective methods of contraception.
Key exclusion criteria (17 listed)
- History of anaphylaxis or clinically significant drug allergy or drug allergy witnessed in previous studies with experimental drugs, or allergy to the active ingredients or excipients of the investigational product.
- History of allergic reactions to monoclonal antibodies or antibody fragments.
- History or presence of infectious or non-infectious liver disease, including but not limited to a history of alcoholic liver disease, non-alcoholic steatohepatitis, drug or autoimmune liver disease.
- History or presence of immune-mediated diseases, including but not limited to idiopathic thrombocytopenic purpura, systemic lupus erythematosus, rheumatoid arthritis.
- History or presence of any chronic infectious condition, including but not limited to tuberculosis or parasitic infections.
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 |
|---|---|---|
| 162The investigational product 162 is a novel neutralizing antibody targeting HBsAg, for the treatment of patients with chronic hepatitis B | Biological | 162 |
| Placeboan intervention that appearance is the same as 162, but contains no active ingredients | Other | placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Day 1-Day 28
incidence and severity of adverse events after the administrtion of 162 or placebo
7 secondary outcomes
Peak Plasma Concentration (Cmax)
Time frame: Day 1-Day 28
Area under the plasma concentration versus time curve from time 0 to the last test time(AUC last)
Time frame: Day 1-Day 28
Area under the plasma concentration versus time curve from time 0 to infinity time(AUC 0-∞)
Time frame: Day 1-Day 28
Half life (t1/2)
Time frame: Day 1-Day 28
Clearance (Cl)
Time frame: Day 1-Day 28
Apparent volume of distribution (Vd)
Time frame: Day 1-Day 28
Immunogenicity
Time frame: Day 1-Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Individual participant dataSharing planned: No
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Chronic Hepatitis B
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 162 in people with Chronic Hepatitis B, run by Yangshengtang Co., Ltd at 1 site in Australia.
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 6 inclusion and 17 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: finished, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: Day 1-Day 28). 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 27 Nov 2023.