Clinical trial NCT05674448: A Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With Chronic Hepatitis B and Hepatitis D Co-infection
Official title: An Open-label Phase IIa Study to Evaluate the Antiviral Effect and Safety of HH-003 Injection in Subjects With Chronic Hepatitis B and D Co-infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Hepatitis B and Hepatitis D Co-infection
Lead sponsor: Huahui Health
Sponsor class: INDUSTRY
First posted: 2023-01-06
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open-label phase IIa study of HH-003 to evaluate its antiviral activity and safety in subjects with chronic hepatitis B and hepatitis D co-infection. HH-003 is a human monoclonal antibody targeting the pre-S1 domain of the HBV large envelope protein. It blocks engagement of preS1 with sodium taurocholate co-transporting polypeptide (NTCP), the cellular receptor for HBV/HDV.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent form;
* Male or female subjects aged from 18 to 70 years inclusively;
* 18 kg/m2≤BMI≤32 kg/m2, body weight ≥45 kg for men and ≥40 kg for women;
* Positive HBsAg, anti-HDV IgG antibody and HDV RNA at screening;
* Women of childbearing potential or male subjects with female partners of childbearing potential should agree to use an adequate and highly effective contraceptions from screening to the end of study or until 12 weeks after last dose of the study drug (whichever is longer).

Exclusion Criteria:

* Be pregnant or lactating at screening;
* Subjects with decompensated liver cirrhosis;
* Subjects with liver dysfunction (including but not limited to ascites, hepatic encephalopathy and upper gastrointestinal bleeding) within 3 months prior to screening;
* Average daily alcohol consumption \>40g for men and \>20g for women or drug abuse within 6 months prior to screening;
* Subjects with other serious diseases that is inappropriate for study participation per the Investigator's or the Sponsor's discretion (including but not limited to serious cardiac or pulmonary disease, chronic or recurrent urinary disorders, uncontrolled diabetes and autoimmune diseases, epilepsy requiring treatment);
* History of hepatocellular carcinoma (HCC) or hepatocellular carcinoma suggested by liver histopathology or liver imaging;
* Interferon antiviral therapy within 1 year prior to screening.

Primary outcomes:
measure: Percentage of Participants with HBV DNA Negativation or Decrease by ≥1 log10 from Baseline at Week 24
timeFrame: Week 24
measure: Percentage of Participants with HDV RNA Negativation or Decrease by ≥1 log10 from Baseline at Week 24
timeFrame: Week 24
measure: Change from Baseline in Serum HBsAg Levels at Week 24
timeFrame: from baseline to Week 24
Secondary outcomes:
measure: Percentage of participants with ALT normalization at week 24
timeFrame: Week 24
measure: Changes from Baseline in Serum HBsAg Levels during the Study Period
timeFrame: from baseline to Week 48
measure: Changes from Baseline in Serum HBV RNA Levels during the Study Period
timeFrame: from baseline to Week 48
measure: Changes from Baseline in Serum HBV DNA Levels during the Study Period
timeFrame: from baseline to Week 48
measure: Changes from Baseline in Serum HDV RNA Levels during the Study Period
timeFrame: from baseline to Week 48
measure: Changes from Baseline in Serum HBeAg Levels in HBeAg-positive Subjects at Screening
timeFrame: from baseline to Week 48
Other outcomes:
Locations:
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
Study officials:
References: