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
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.
- 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