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CompletedNCT05542979Updated Sep 16, 2022

A Study to Evaluate the Safety, Tolerability of HH-003 Injection in Participants With Chronic Hepatitis B Virus Infection

A Phase 1 interventional study of HH-003 injection and Placebo in Chronic HBV Infection, sponsored by Huahui Health. Completed at 11 sites in China. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-09-16.

Sponsored by Huahui Health · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 1 month after the study started (first participant enrolled Aug 2019, registered Sep 2022).
Phase
Phase 1
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
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Study summary

This is a multicenter, randomized, double-blind, placebo-controlled, multiple-ascending dose phase Ib study of HH-003 injection, which is a monoclonal antibody targeting Hepatitis B virus. This study aims to evaluate the safety, tolerability and pharmacokinetics of HH-003 injection in treatment-naive participants chronically infected with hepatitis B virus.

02

Conditions studied

  • Chronic HBV Infection
03

In context

Lead sponsor

Huahui Health is the lead sponsor of 18 studies on the registry; 5 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

  • 18 to 45 years old
  • Body weight ≥ 45 kg for men and ≥ 40 kg for women, and 18 kg/m\^2≤BMI≤28 kg/m\^2
  • Positive serum HBsAg or HBV DNA for at least 6 months,or previous liver biopsy results confirm the Hepatitis B
  • HBeAg positive, and 2000 IU/mL\<HBsAg\<100,000 IU/mL
  • Have not received interferon treatment before, and have not received nucleotide/nucleoside analogue treatment within 6 months prior to Screening

Exclusion criteria

Exclusion Criteria:

  • Positive test for hepatitis C antibody (HCV-Ab), treponema pallidum antibody (TP-Ab), or anti-HIV antibody (HIV-Ab)
  • Hemoglobin \<100 g/L, platelets \<100,000/mm\^3 (100×10\^9/L), absolute neutrophils count \<1,500/mm\^3 (1.5×10\^9/L)
  • Serum albumin \<35 g/L, international normalized ratio (INR)>1.5; serum creatinine >115 μmol/L, Glomerular Filtration Rate (GFR) \<70 mL/min/1.73m\^2(calculated by Modification of Diet in Renal Disease (MDRD) formula); uric acid>540 μmol/L; triglyceride>3.5mmol/L
  • Participants with a history of alcoholic liver disease, moderate or higher nonalcoholic fatty liver disease, autoimmune liver disease, Gilbert syndrome or other hereditary liver disease, drug-induced liver disease and other chronic liver diseases
  • Participants with a history of progressive liver fibrosis (eg: liver cirrhosis diagnosed by liver histopathological examination, or esophagogastric varices diagnosed by endoscopy)
  • Participants with confirmed or suspected decompensated HBV cirrhosis with complications of ascites, hepatic encephalopathy, gastroesophageal variceal bleeding, and Child-Pugh score of B\~C, or with primary liver cancer
  • Alpha Fetoprotein (AFP) >50 ng/ml at screening or the suspected malignant liver mass indicated by imaging
  • Any previous or current malignant neoplasms
  • Breast-feeding or pregnant females
  • Participants who are not suitable to participate in this trial per the Investigator's judgment
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
68 participants (actual)

Study arms

  • Experimental
    HH-003 Group

    Drug: HH-003 injection

  • Placebo comparator
    Placebo Group

    Drug: Placebo

Interventions

  • HH-003 injection is administrated via I.V. infusion

  • DrugPlacebo

    Placebo is administrated via I.V. infusion

06

What researchers measure

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: From the first dose of study drug until Day 57

  2. Peak concentration (Cmax)

    Time frame: From predose to Day 113

  3. Area under the drug-time curve (AUC0-2W)

    Time frame: From predose to Day 113

  4. Area under the drug-time curve (AUClast)

    Time frame: From predose to Day 113

  5. Area under the drug-time curve (AUCinf)

    Time frame: From predose to Day 113

07

Study locations

11 sites
  • Beijing Ditan Hospital,Capital Medical University
    Beijing, Beijing Municipality 100015, China
  • Beijing Friendship Hospital,Capital Medical University
    Beijing, Beijing Municipality 100050, China
  • Beijing Youan Hospital,Capital Medical University
    Beijing, Beijing Municipality 100069, China
  • Mengchao Hepatobiliary Hospital Of Fujian Medical University
    Fuzhou, Fujian 350025, China
  • The First Hospital of Lanzhou University
    Lanzhou, Gansu 730000, China
  • The First Affiliated Hospital Of Zhengzhou University
    Zhengzhou, Henan 450000, China
  • Henan Infectious Disease Hospital(The Sixth Peoples Hospital Of Zhengzhou)
    Zhengzhou, Henan 450006, China
  • The First Hospital of Jilin University
    Changchun, Jilin 130021, China
  • Yanbian University Hospital(Yanbian Hospital)
    Yanji, Jilin 133000, China
  • Shandong Public Health Clinical Center
    Jinan, Shandong 250102, China
  • The First Affiliated Hospital,Zhejiang University School Of Medicine
    Hangzhou, Zhejiang 310003, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05542979
Lead sponsor
Huahui Health
Responsible party
Sponsor
First posted
Sep 16, 2022
Start date
Aug 5, 2019
Primary completion
Mar 15, 2022
Completion
Mar 15, 2022
Last update
Sep 16, 2022

Oversight

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

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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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