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Not yet recruitingNCT07884864Updated Oct 21, 2026

A Clinical Study of AHB-121 in Healthy Participants and Chronic Hepatitis B (CHB) Participants

A Phase 1 interventional study of AHB-121 and Placebo in Chronic Hepatitis B Virus, sponsored by Ausper Biopharma Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.

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

Updated Oct 21, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This is a clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of AHB-121 injection in healthy and chronic hepatitis B participants.

02

Conditions studied

  • Chronic Hepatitis B Virus

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Keywords

  • chronic hepatitis B
03

In context

Hepatitis B, Chronic

954 studies on the registry are indexed under Hepatitis B, Chronic; 147 are open to participants now.

This study's planned enrollment of 110 is close to the median of 100 across 692 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

  • Sign the informed consent form and be able to complete the research as required.
  • Age and weight meet the requirements.
  • During the screening, the results of physical examination, vital signs, laboratory tests, electrocardiogram, etc. are normal or have no clinical significance(healthy individuals).
  • Take effective contraceptive measures as required.
  • During the screening, HBsAg, HBV DNA, ALT, and HBeAg meet certain indicators (CHB participants).

Exclusion criteria

Exclusion Criteria:

  • Have a serious systemic disease or a history of malignant tumor.
  • Have other liver diseases besides chronic HBV infection, or have liver dysfunction, significant liver fibrosis/ cirrhosis, history of liver cell carcinoma or suspected cases.
  • Have autoimmune diseases or diseases with a risk of immune activation.
  • Have a questionable allergy to the test drugs and their components, or have an allergic constitution.
  • Participate in other clinical trials or receive investigational drug treatment within the specified time before screening, and have received related drug
  • Have received solid organ transplantation or hematopoietic stem cell transplantation before screening.
  • Have acute infection, major trauma or major surgery with clinical significance that has not fully recovered within the specified time before screening, or have a surgical plan during the study.
  • Have abnormal laboratory tests, vital signs or electrocardiogram results during screening and have clinical significance as judged by the researcher.
  • Have positive screening for related infectious diseases.
  • Have a history of drug abuse or alcoholism; or have a large amount of smoking before screening and cannot stop during the study.
  • Have consumed caffeine, xanthine-containing foods or beverages, or engaged in intense exercise within the specified time before administration, or have been unable to stop during the study.
  • Have positive urine drug screening or alcohol breath test during screening; have donated blood or lost a large amount of blood before screening, received blood transfusion, or have a blood donation plan during the study.
  • Have a positive pregnancy test during screening.
  • Abnormal skin at the injection site.
  • Have a history of fainting or hemisomnia, difficulty in blood collection, or inability to tolerate venipuncture blood collection.
  • The researcher considers that there are other factors that make one unsuitable to participate in this trial.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    Healthy participants group

    Drug: AHB-121 · Drug: Placebo

  • Experimental
    CHB group

    Drug: AHB-121 · Drug: Placebo

Interventions

  • DrugAHB-121

    AHB-121 will be used per week

  • DrugPlacebo

    Placebo will be used per week

06

What researchers measure

Primary outcomes

  1. Safety indicators

    Incidence and severity of TEAE/SAE; changes in laboratory tests, ECG, physical examination, and vital signs compared to baseline

    Time frame: Up to 18weeks

07

Study locations

1 site
  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
    Shanghai, Shanghai Municipality, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07884864
Lead sponsor
Ausper Biopharma Co., Ltd.
Responsible party
Sponsor
First posted
Oct 21, 2026
Start date
Oct 28, 2026 (estimated)
Primary completion
Apr 30, 2027 (estimated)
Completion
Feb 29, 2028 (estimated)
Last update
Oct 21, 2026

Study contacts

Lu
Contact
clinicaltrial@ausperbio.com
057186959519
Qing Xie
principal investigator · Ruijin Hospital
Jing Sun
principal investigator · Ruijin Hospital

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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