HBV InfectionPhase 1NCT07771140
A Phase I Clinical Trial to Evaluate HECN30227 Injection in Healthy Subjects and Subjects With Chronic Hepatitis B
A Phase 1 study testing HECN30227 injection(SAD) and HECN30227 injection (MAD) in people with HBV Infection, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
To evaluate the safety, efficacy, pharmacokinetics and immunogenicity of single and multiple doses of HECN30227 Injection in healthy volunteers and patients with chronic hepatitis B Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HBV Infection
- What is being tested?
- HECN30227 injection(SAD) and HECN30227 injection (MAD)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 2 Dec 2025to 11 Apr 2027
- 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
- Subjects must understand and comply with the study procedures, voluntarily participate, and sign the informed consent form.
- Male subjects must weigh at least 50 kg; female subjects must weigh at least 45 kg.
- Vital signs, physical examination, laboratory tests, electrocardiography (ECG), chest X-ray, and abdominal ultrasound (liver, gallbladder, spleen, pancreas, and both kidneys) are normal, or abnormalities are judged by the investigator to be clinically insignificant.
- Female subjects of childbearing potential or male subjects must agree to use effective contraception from the time of signing the informed consent form until 6 months after the last dose of study drug.
- Subjects must have received stable treatment with nucleos(t)ide analogues (NAs) (e.g., entecavir, tenofovir disoproxil fumarate, or tenofovir alafenamide) for at least 6 months prior to screening.
- HBV DNA < 90 IU/mL at screening.
- HBsAg > 100 IU/mL at screening.
- Serum ALT and AST ≤ 2 × ULN, and total serum bilirubin ≤ 2 × ULN at screening and baseline.
Who cannot join
- Subjects who have undergone major surgery within 3 months prior to screening, or plan to undergo surgery during the study period.
- Subjects with a history of allergy to the study drug or any of its components, or with allergic diathesis (allergic to two or more types of drugs or foods).
- Subjects with a history of alcohol abuse within 1 year prior to screening , or those with a positive blood alcohol test result prior to dosing.
- Subjects with a history of drug abuse or use of illicit drugs within 1 year prior to screening, or those with a positive urine drug screening result prior to dosing.
- Subjects who donated blood ≥200 mL, or donated any blood component, or suffered a total blood loss ≥200 mL for any reason within 3 months prior to screening; or those with a history of blood transfusion or blood product administration.
- Subjects who participated in another clinical trial within 3 months prior to screening.
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- Subjects who develop an acute illness (e.g., acute respiratory disease) or receive concomitant medication from the time of signing the informed consent form to prior to the first dose.
- Subjects who are breastfeeding or have a positive serum pregnancy test result.
- Subjects with significant hepatic fibrosis or liver cirrhosis.
- Subjects with a history of hepatic decompensation manifestations or disease at screening or in the past, including but not limited to ruptured esophageal and gastric variceal bleeding, ascites, hepatic encephalopathy, etc.
- Subjects diagnosed with any malignant tumor within 5 years prior to screening , or those assessed to have potential malignant tumors at present.
- Subjects with international normalized ratio (INR) >1.5, or platelet count <90×10⁹/L, or serum albumin <35 g/L at screening.
- Subjects with alpha-fetoprotein (AFP) >50 ng/mL at screening.
- Subjects with endogenous creatinine clearance (CLcr) <60 mL/min/1.73 m² at screening.
- Subjects receiving, or who have received any interferon-containing regimen or immunosuppressive therapy within 1 year prior to screening.
- Subjects whom the investigator considers unsuitable for participation in this trial for any other reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Anhui Medical University
Hefei
wei Hu
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Dose-escalating Phase I Trial With Single and Multiple Dosing to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of HECN30227 Injection in Healthy Volunteers and Subjects With Chronic Hepatitis B
To evaluate the safety, efficacy, pharmacokinetics and immunogenicity of single and multiple doses of HECN30227 Injection in healthy volunteers and patients with chronic hepatitis B
- Conditions
- HBV Infection
- Being tested
- HECN30227 injection(SAD), Placebo(MAD), Placebo(SAD), HECN30227 injection (MAD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HECN30227 injection(SAD)Drug
single subcutaneous administrations
Placebo(MAD)Drug
0.9% Sodium Chloride Injection
Placebo(SAD)Drug
0.9% Sodium Chloride Injection
HECN30227 injection (MAD)Drug
multiple subcutaneous administrations
| Study group | Role | What they receive |
|---|---|---|
| HECN30227 50~800 mg | Experimental | Not described Receives: Drug: HECN30227 injection(SAD); Drug: Placebo(SAD) |
| HECN30227 100~400 mg | Experimental | Not described Receives: Drug: Placebo(MAD); Drug: HECN30227 injection (MAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events In Part 1
A summary of adverse events, including Serious Adverse Events(SAEs)
Measured: 85 days
Number of Adverse Events In Part 2
A summary of adverse events, including Serious Adverse Events(SAEs)
Measured: 169days
Secondary outcomes (5)
Peak Plasma Concentration (Cmax) of single dose
Measured: 48 h
Peak Plasma Concentration (Cmax) of Multiple dose
Measured: 57 days
Area under the plasma concentration-time curve(AUC0-t）
Measured: 57 days
Time to the peak plasma concentration (Tmax)
Measured: 57 days
Maximum Change of Serum HBsAg From Baseline
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start2 Dec 2025
- Primary completion11 Apr 2027 (estimated)
- Study completion11 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBV InfectionStudies of the same condition, open and under way.
- More trials run by Sunshine Lake Pharma Co., Ltd.The sponsor's other registered studies.
- 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
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771140
- Sponsor's protocol ID
- HECN30227-HBV-101
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Dose-escalating Phase I Trial With Single and Multiple Dosing to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of HECN30227 Injection in Healthy Volunteers and Subjects With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT07771140
- Acronym / sponsor ID
- HECN30227-HBV-101
- Conditions
- HBV Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- 11 Apr 2027 (estimated)
- Study completion
- 11 Apr 2027 (estimated)
- First posted
- 18 Aug 2026 (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.
To evaluate the safety, efficacy, pharmacokinetics and immunogenicity of single and multiple doses of HECN30227 Injection in healthy volunteers and patients with chronic hepatitis B
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HECN30227 50~800 mg | Experimental | Drug: HECN30227 injection(SAD), Drug: Placebo(SAD) |
| HECN30227 100~400 mg | Experimental | Drug: Placebo(MAD), Drug: HECN30227 injection (MAD) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must understand and comply with the study procedures, voluntarily participate, and sign the informed consent form.
- Male subjects must weigh at least 50 kg; female subjects must weigh at least 45 kg.
- Vital signs, physical examination, laboratory tests, electrocardiography (ECG), chest X-ray, and abdominal ultrasound (liver, gallbladder, spleen, pancreas, and both kidneys) are normal, or abnormalities are judged by the investigator to be clinically insignificant.
- Female subjects of childbearing potential or male subjects must agree to use effective contraception from the time of signing the informed consent form until 6 months after the last dose of study drug.
- Subjects must have received stable treatment with nucleos(t)ide analogues (NAs) (e.g., entecavir, tenofovir disoproxil fumarate, or tenofovir alafenamide) for at least 6 months prior to screening.
Key exclusion criteria (16 listed)
- Subjects who have undergone major surgery within 3 months prior to screening, or plan to undergo surgery during the study period.
- Subjects with a history of allergy to the study drug or any of its components, or with allergic diathesis (allergic to two or more types of drugs or foods).
- Subjects with a history of alcohol abuse within 1 year prior to screening , or those with a positive blood alcohol test result prior to dosing.
- Subjects with a history of drug abuse or use of illicit drugs within 1 year prior to screening, or those with a positive urine drug screening result prior to dosing.
- Subjects who donated blood ≥200 mL, or donated any blood component, or suffered a total blood loss ≥200 mL for any reason within 3 months prior to screening; or those with a history of blood transfusion or blood product administration.
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 |
|---|---|---|
| HECN30227 injection(SAD)single subcutaneous administrations | Drug | HECN30227 50~800 mg |
| Placebo(MAD)0.9% Sodium Chloride Injection | Drug | HECN30227 100~400 mg |
| Placebo(SAD)0.9% Sodium Chloride Injection | Drug | HECN30227 50~800 mg |
| HECN30227 injection (MAD)multiple subcutaneous administrations | Drug | HECN30227 100~400 mg |
Primary outcome
Number of Adverse Events In Part 1
Time frame: 85 days
A summary of adverse events, including Serious Adverse Events(SAEs)
Number of Adverse Events In Part 2
Time frame: 169days
A summary of adverse events, including Serious Adverse Events(SAEs)
5 secondary outcomes
Peak Plasma Concentration (Cmax) of single dose
Time frame: 48 h
Peak Plasma Concentration (Cmax) of Multiple dose
Time frame: 57 days
Area under the plasma concentration-time curve(AUC0-t）
Time frame: 57 days
Time to the peak plasma concentration (Tmax)
Time frame: 57 days
Maximum Change of Serum HBsAg From Baseline
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HECN30227 injection(SAD) and HECN30227 injection (MAD) in people with HBV Infection, run by Sunshine Lake Pharma Co., Ltd. at 1 site 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 8 inclusion and 16 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 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 wei Hu (13856086475, hwgcp@ayefy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events In Part 1 (time frame: 85 days). The study lists 2 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 18 Aug 2026.