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RecruitingNCT07600788Updated Jul 29, 2026

A Clinical Study Evaluating the Pharmacokinetic Characteristics and Safety of AHB-137 Injection in Participants With Mild to Moderate Liver Dysfunction and Those With Normal Liver Function.

A Phase 1 interventional study of AHB-137 injection in Chronic Hepatitis B, sponsored by Ausper Biopharma Co., Ltd.. Recruiting at 5 sites in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-29.

Sponsored by Ausper Biopharma Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 4 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

A clinical study evaluating the pharmacokinetic characteristics and safety of AHB-137 injection in participants with mild to moderate liver dysfunction and those with normal liver function.

02

Conditions studied

  • Chronic Hepatitis B

Keywords

  • Hepatitis B
  • Chronic
03

In context

Hepatitis B, Chronic

895 studies on the registry are indexed under Hepatitis B, Chronic; 151 are open to participants now.

This study's planned enrollment of 32 is below the median of 100 across 659 interventional studies indexed under Hepatitis B, Chronic.

Browse Hepatitis B, Chronic studies →

Lead sponsor

Ausper Biopharma Co., Ltd. is the lead sponsor of 14 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Voluntarily participate in the study, sign an form before the study and be able to complete the study according to the requirements of the protocol;
  • At the time of signing the informed consent form, male or female participants aged 18-65 years (including threshold values);
  • meets the criteria;
  • Take effective measures as required;
  • Participants with liver function impairment need to meet certain liver function assessments;
  • Participants with normal liver function should meet certain age, weight, and gender requirements to match those with liver function impairment, and should also undergo certain physical and laboratory tests.

Exclusion criteria

Exclusion Criteria:

  • Diagnosed or suspected liver cancer participants who have undergone liver transplantation;
  • History of vasculitis or presence of signs and symptoms of potential vasculitis or laboratory tests;
  • Unstable control of hypertension or diabetes, progressive nervous system disease, history of immune related extrahepatic diseases, and unstable cardiac function;
  • Participants with a history of malignant tumors or undergoing malignant tumor assessment;
  • Screening for participants who have undergone significant trauma or surgery within the previous 3 months, as well as those who plan to undergo surgery;
  • Participants with thyroid dysfunction who are not suitable for inclusion in the study;
  • Allergic or allergic constitution to AHB-137;
  • Long term regular receipt of anticoagulant or antiplatelet drugs is required;
  • Those who have received any antisense oligonucleotide drugs or have been treated with siRNA drugs or interferon within the 12 months prior to screening;
  • Currently using or using any medication within the past 3 months prior to screening, except for short-term use or the use of topical/inhaled ; Individuals who have used immunomodulators and cytotoxic drugs within the 6 months prior to administration;
  • Those who have a history of vaccination or a plan to receive within one month before administration, those who have used creatine containing fitness supplements 14 days before administration, and those who have used albumin 14 days before administration;
  • , Syphilis positive ;
  • Those who are participating in another clinical trial and have not been eluted as required;
  • Positive results in urine drug screening and alcohol breath screening tests during screening;
  • Those who drink excessively and consume prohibited foods and beverages before administration;
  • Participants who have donated blood (or lost blood) ≥ 400 ml, received whole blood, or used red blood cell suspension within the past 3 months prior to screening; Individuals with a history of needle or blood dizziness, difficulty in blood collection, or intolerance to venipuncture blood collection;
  • Long term regular vigorous exercise or intense exercise within 48 hours before screening;
  • Any other circumstances or conditions that the researcher deems unsuitable for the subject to participate in this study;
  • Diseases that need to be excluded according to the merger plan for patients with abnormal liver function;
  • The laboratory test results do not meet the requirements of the protocol;
  • Participants with normal liver function who have a history of chronic liver disease or known liver or biliary abnormalities;
  • Participants with normal liver function who have used traditional Chinese medicine or other systemic medications with potential liver toxicity 14 days before administration;
  • Participants with normal liver function and abnormal values.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    Part1: Child-Pugh B group

    Drug: AHB-137 injection

  • Experimental
    Part2: Child-Pugh A group

    Drug: AHB-137 injection

  • Experimental
    Part1:Participants with normal liver function group

    Drug: AHB-137 injection

  • Experimental
    Part2:Participants with normal liver function group

    Drug: AHB-137 injection

Interventions

06

What researchers measure

Primary outcomes

  1. Key PK parameters of AHB-137 injection after single subcutaneous administration: peak concentration (Cmax)

    Time frame: Up to day 29

  2. Key PK parameters of AHB-137 injection after single subcutaneous administration: area under the drug time curve from 0 to infinity (AUC)

    Time frame: Up to day 29

Secondary outcomes

  1. PK parameter: Area under the drug time curve from 0 to the last endpoint quantifiable concentration time point (AUCo- Last)

    Time frame: Up to day 29

  2. PK parameter: Area under the drug time curve from 0 to 24 hours (AUCo-24)

    Time frame: Up to day 29

  3. PK parameter: Area under the drug time curve from 0 to 168 hours (AUCo-168)

    Time frame: Up to day 29

  4. PK parameter: D8 blood concentration (C168)

    Time frame: Up to day 29

  5. PK parameter: peak time (Tmax)

    Time frame: Up to day29

  6. Safety indicators

    The proportion of participants who experienced all adverse events (TEAEs), serious adverse events (SAEs), and adverse events of particular concern (AESIs) during the treatment period after a single subcutaneous administration of AHB-137 injection; And laboratory tests, 12 lead ECG, and changes in vital signs compared to baseline.

    Time frame: Up to day 29

07

Study locations

1 of 5 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for May 2028, 22 months after the start.

Of 73 industry-sponsored phase 1 interventional studies under Hepatitis B, Chronic, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 22 months is above that.

Counting every sponsor, half of 81 studies reached it within 16 months; a quarter within 6 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
May 14, 2026
First posted
May 22, 2026
StartActual
Jul 9, 2026
Primary completionEst.
May 15, 2028
CompletionEst.
May 15, 2028
Last update
Jul 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07600788
Responsible party
Sponsor
First posted
May 22, 2026
Start date
Jul 9, 2026
Primary completion
May 15, 2028 (estimated)
Completion
May 15, 2028 (estimated)
Last update
Jul 29, 2026

Study contacts

Lu
Contact
clinicaltrial@ausperbio.com
0571-86959519
Jing Zhang
principal investigator · Huashan Hospital
Yuxian Huang
principal investigator · Huashan Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Hepatitis B Virus Antisense Oligonucleotide AHB-137

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