Chronic HBV InfectionPhase 1NCT05542979
A Study to Evaluate the Safety, Tolerability of HH-003 Injection in Participants With Chronic Hepatitis B Virus Infection
A Phase 1 study testing HH-003 injection in people with Chronic HBV Infection, run by Huahui Health at 11 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Chronic HBV Infection
- What is being tested?
- HH-003 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 11 sitesChina
- Study dates
- 5 Aug 2019to 15 Mar 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
Beijing Ditan Hospital,Capital Medical University
Beijing, Beijing Municipality, 100015
Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, 100050
Beijing Youan Hospital,Capital Medical University
Beijing, Beijing Municipality, 100069
The First Hospital of Jilin University
Changchun, Jilin, 130021
Mengchao Hepatobiliary Hospital Of Fujian Medical University
Fuzhou, Fujian, 350025
The First Affiliated Hospital,Zhejiang University School Of Medicine
Hangzhou, Zhejiang, 310003
Shandong Public Health Clinical Center
Jinan, Shandong, 250102
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Yanbian University Hospital(Yanbian Hospital)
Yanji, Jilin, 133000
The First Affiliated Hospital Of Zhengzhou University
Zhengzhou, Henan, 450000
Henan Infectious Disease Hospital(The Sixth Peoples Hospital Of Zhengzhou)
Zhengzhou, Henan, 450006
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase Ib Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple-dose HH-003 Injection in Treatment Naïve Participants With HBeAg-positive Chronic HBV Infection
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.
- Conditions
- Chronic HBV Infection
- Being tested
- HH-003 injection, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HH-003 injectionDrug
HH-003 injection is administrated via I.V. infusion
PlaceboDrug
Placebo is administrated via I.V. infusion
| Study group | Role | What they receive |
|---|---|---|
| HH-003 Group | Experimental | Not described Receives: Drug: HH-003 injection |
| Placebo Group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Measured: From the first dose of study drug until Day 57
Peak concentration (Cmax)
Measured: From predose to Day 113
Area under the drug-time curve (AUC0-2W）
Measured: From predose to Day 113
Area under the drug-time curve (AUClast)
Measured: From predose to Day 113
Area under the drug-time curve (AUCinf)
Measured: From predose to Day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start5 Aug 2019
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic HBV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huahui Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542979
- Sponsor's protocol ID
- HH0031802
- Status last verified
- Sep 2022
- First submitted
- 11 Sep 2022
- Last updated
- 16 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase Ib Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple-dose HH-003 Injection in Treatment Naïve Participants With HBeAg-positive Chronic HBV Infection
- ClinicalTrials.gov ID
- NCT05542979
- Acronym / sponsor ID
- HH0031802
- Conditions
- Chronic HBV Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Huahui HealthIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HH-003 Group | Experimental | Drug: HH-003 injection |
| Placebo Group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HH-003 injectionHH-003 injection is administrated via I.V. infusion | Drug | HH-003 Group |
| PlaceboPlacebo is administrated via I.V. infusion | Drug | Placebo Group |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: From the first dose of study drug until Day 57
Peak concentration (Cmax)
Time frame: From predose to Day 113
Area under the drug-time curve (AUC0-2W）
Time frame: From predose to Day 113
Area under the drug-time curve (AUClast)
Time frame: From predose to Day 113
Area under the drug-time curve (AUCinf)
Time frame: From predose to Day 113
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
Related trials for Chronic HBV Infection
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HH-003 injection in people with Chronic HBV Infection, run by Huahui Health at 11 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: From the first dose of study drug until Day 57). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2022.