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Chronic Hepatitis B InfectionPhase 1NCT07511218

A Phase I Clinical Study of AHB - 171 in Healthy Participants(HP) and Chronic Hepatitis B (CHB) Participants

A Phase 1 study testing AHB-171 Injection and Nucleos(t)ide Analogue (NA) in people with Chronic Hepatitis B Infection, run by Ausper Biopharma Co., Ltd. at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to evaluate the safety, tolerability, immunogenicity and Pharmacokinetics (PK) characteristics of AHB-171 Injection in healthy participants (Part A) and participants with chronic hepatitis B (CHB, Part B), and assess its preliminary efficacy in CHB participants. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Hepatitis B Infection
What is being tested?
AHB-171 Injection and Nucleos(t)ide Analogue (NA)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
110 participants
Where
2 sitesChina
Study dates
13 Apr 2026to 30 Jun 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy Participants:
  • Male or female participants, aged 18-55 years old (inclusive);
  • Body mass index between 18.0 and 28.0 kg/m^2 (inclusive);
  • Laboratory safety tests during the screening period, 12-lead electrocardiogram (ECG), abdominal ultrasound, thyroid ultrasound, chest anteroposterior position, etc., are assessed by the investigatoras normal or abnormal without clinical significance;
  • Female participants of childbearing potential must not be pregnant or lactating, must have a negative pregnancy test at screening, and must agree to use effective contraceptive methods and refrain from donating eggs from screening until 6 months after the last dose of the study drug.
  • Male participants must agree to use highly effective contraceptive methods (to ensure effective contraception for their female partners of childbearing potential) and refrain from donating sperm from screening until 6 months after the last dose of the study drug. Liver and kidney function tests meet the requirements at the time of screening.
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  • CHB Participants:
  • Male or female participants, aged 18-65 years old (inclusive);
  • Body mass index between 18.0 and 32.0 kg/m^2 (inclusive);
  • Participants who take effective contraceptive measures as required;
  • HBsAg > 100 IU/mL and ≤ 3000 IU/mL, and HBV DNA < 100 IU/mL at screening.
  • Have received stable treatment with NA for at least 6 months and stable on the same NA for at least 3 months before screening.

Who cannot join

  • Healthy Participants:
  • Currently participating in another study, or within 5 half-lives/3 months of the last dose of a previous investigational product.
  • Presence diseases (cardiovascular, neurological, renal, immunological, metabolic, etc.) or malignant tumors.- Major surgery or severe trauma within the past 6 months.
  • Acute infection (e.g., influenza, gastroenteritis) within 14 days; vaccination within 28 days prior to screening.
  • Allergy to any investigational drug component.
  • Heavy Smoking (> 5 cigarettes/day); history of drug/alcohol abuse; consumption of caffeine or alcohol within 48 hours before dosing.
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  • Blood donation/loss ≥400 mL or transfusion within 12 weeks, or plan to donate during study.
  • Abdominal skin issues that may affect drug injection/observation.
  • Positive for HBV, HCV, HIV, or syphilis.
  • Clinically significant ECG abnormality or TdP risk factors.
  • Any condition judged unsuitable by investigator.
  • CHB Participants:
  • Currently participating in another study, or within 5 half-lives/3 months of the last dose of a previous investigational product.
  • Presence of ascites, gastrointestinal bleeding, hepatic encephalopathy, or varices.
  • History or suspicion of hepatocellular carcinoma (HCC); AFP > 50 ng/mL.
  • Diagnosed or Suspected cirrhosis within 12 months.
  • History of transplantation, autoimmune diseases, or severe systemic diseases (besides chronic HBV).
  • Use of ASO, siRNA (oligonucleotide therapies), or interferon within 12 months.
  • Major injury/surgery within 6 months, planned surgery during study, or acute infection within 14 days.
  • Allergy to any investigational drug component.
  • Blood donation/loss ≥400 mL or transfusion within 12 weeks, or plan to donate during study.
  • Abdominal skin issues that may affect drug injection/observation.
  • Key laboratory result not suitable for clinical trial.
  • HIV, HCV, or active syphilis infection; uncured hepatitis A, D, or E.
  • Clinically significant ECG abnormality or TdP risk factors.
  • Any condition judged unsuitable by investigator.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Bella Lu contact

0571-86959519

clinicaltrial@ausperbio.com

China2 sites, 2 recruiting

  • AusperBio Investigational Site

    Ch’ang-ch’un, Jilin

    Bella Lu, 0571-86959519, clinicaltrial@ausperbio.com

    Yanhua Ding

    Recruiting

  • AusperBio Investigational Site

    Hangzhou, Zhejiang, 310052

    Bella Lu, 0571-86959519, clinicaltrial@ausperbio.com

    陆, clinicaltrial@ausperbio.com

    Recruiting

Other trials in China

About this study

Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AHB - 171 Injection in Healthy Participants (HP) and Chronic Hepatitis B(CHB) Participants

The goal of this clinical trial is to evaluate the safety, tolerability, immunogenicity and Pharmacokinetics (PK) characteristics of AHB-171 Injection in healthy participants (Part A) and participants with chronic hepatitis B (CHB, Part B), and assess its preliminary efficacy in CHB participants.

Being tested
AHB-171 Injection, Placebo, Nucleos(t)ide Analogue (NA)
Keywords
Hepatitis B, Chronic
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.

  • AHB-171 InjectionDrug

    AHB-171 Injection is adminstrated via subcutaneous injection

  • PlaceboDrug

    Placebo is admistrated via subcutaneous injection

  • Nucleos(t)ide Analogue (NA)Drug

    Oral administration

Study groups in NCT07511218
Study groupRoleWhat they receive
AHB-171 and placebo in CHB (Part B: MAD)ExperimentalDrug: AHB-171 Injection Drug: Placebo Drug: Nucleos(t)ide Analogue (NA) Background treatment
Receives: Drug: AHB-171 Injection; Drug: Placebo; Drug: Nucleos(t)ide Analogue (NA)
AHB-171 and placebo in HP(Part A: SAD)ExperimentalDrug: AHB-171Injection Drug: Placebo
Receives: Drug: AHB-171 Injection; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A & Part B Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Measured: PartA:Up to 16 weeks, PartB: Up to 48 weeks

  2. Severity of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Measured: PartA:Up to 16 weeks, PartB: Up to 48 weeks

  3. Change from baseline in laboratory tests

    Measured: PartA:Up to 16 weeks, PartB: Up to 48 weeks

  4. Change from baseline in physical examinations

    Measured: PartA:Up to 16 weeks, PartB: Up to 48 weeks

  5. Change from baseline in vital signs

    Measured: PartA:Up to 16 weeks, PartB: Up to 48 weeks

  6. Change from baseline in electrocardiograms (ECGs)

    Measured: PartA:Up to 16 weeks, PartB: Up to 48 weeks

  7. Part A:Plasma Cmax of AHB-171

    Measured: Up to Day 8

  8. Part A:Plasma Tmax of AHB-171

    Measured: Up to Day 8

  9. Part A Plasma AUC of AHB-171

    Measured: Up to Day 8

  10. Part A Plasma t1/2 of AHB-171

    Measured: Up to Day 8

  11. Proportion of participants with clinically significant abnormalities in laboratory tests

    Measured: PartA:Up to 16 weeks, PartB: Up to 48 weeks

  12. Proportion of participants with clinically significant abnormalities in electrocardiograms (ECGs)

    Measured: PartA:Up to 16 weeks, PartB: Up to 48 weeks

  13. Proportion of participants with physical examinations

    Measured: PartA:Up to 16 weeks, PartB: Up to 48 weeks

  14. Proportion of participants with other vital signs

    Measured: PartA:Up to 16 weeks, PartB: Up to 48 weeks

Secondary outcomes (18)

  1. Part A & Part B:Fraction excreted in urine in percentage for AHB-171

    Measured: Up to Day 3 in Part A; Up to Day 30 in Part B

  2. Part A & Part B:Amount excreted in urine for AHB-171

    Measured: Up to Day 3 in Part A; Up to Day 30 in Part B

  3. Part A & Part B:Renal clearance for AHB-171

    Measured: Up to Day 3 in Part A; Up to Day 30 in Part B

  4. Part A & Part B: Immunogenicity: The number of participants develop anti-drug antibodies (ADA) against AHB-171 and the ADA antibody titer

    Measured: Up to 16 weeks in Part A; Up to 48 weeks in Part B

  5. Part B:Plasma Cmax of AHB-171

    Measured: Up to Day 31

  6. Part B:Plasma Tmax of AHB-171

    Measured: Up to Day 31

  7. Part B Plasma AUC of AHB-171

    Measured: Up to Day 31

  8. Part B Plasma t1/2 of AHB-171

    Measured: Up to Day 31

  9. Part B: Proportion of CHB who achieved hepatitis B surface antigen (HBsAg) clearance

    Measured: Up to 48 weeks

  10. Part B: HBsAg Decline in CHB Participants at each assessment time point

    Measured: Up to 48 weeks

  11. Part B:Proportion of participants with HBsAg < 1 IU/mL, < 10 IU/mL, and < 100 IU/mL at each assessment time point.

    Measured: Up to 48 weeks

  12. Part B Proportion of participants achieve seroconversion to anti-HBs (HBsAb >10 IU/L) after HBsAg loss.

    Measured: Up to 48 weeks

  13. Part B Proportion of participants with HBV DNA < LLOQ (10 IU/mL)

    Measured: Up to 48 weeks

  14. Part B Proportion of participants with HBsAg < LOD and HBV DNA < LLOQ at each assessment time point

    Measured: Up to 48 weeks

  15. Part B Serum levels of HBsAg, HBV DNA, HBV RNA, HBcrAg, HBsAb , HBeAb , HBeAg

    Measured: Up to 48 weeks

  16. Part B The level of ALT.

    Measured: Up to 48 weeks

  17. PartB: Proportion of participants achieving ALT normalization and time to ALT normalization among those with baseline ALT > ULN.

    Measured: Up to 48 weeks

  18. Part B Correlation between pharmacokinetic and pharmacodynamic parameters of AHB-171

    Measured: Up to 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2026
  2. Study start13 Apr 2026
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

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
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07511218
Sponsor's protocol ID
AB-17-8002
Status last verified
Jul 2026
First submitted
30 Mar 2026
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AHB-171 Injection and Nucleos(t)ide Analogue (NA) in people with Chronic Hepatitis B Infection, run by Ausper Biopharma Co., Ltd. at 2 sites in China.

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 12 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. 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. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bella Lu (0571-86959519, clinicaltrial@ausperbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A & Part B Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: PartA:Up to 16 weeks, PartB: Up to 48 weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07511218.

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 21 Jul 2026.

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