NCT07771140 A Phase I Clinical Trial to Evaluate HECN30227 Injection in Healthy Subjects and Subjects With Chronic Hepatitis B
| NCT ID | NCT07771140 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sunshine Lake Pharma Co., Ltd. |
| Condition | HBV Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2025-12-02 |
| Primary Completion | 2027-04-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 78 participants in total. It began in 2025-12-02 with a primary completion date of 2027-04-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
Inclusion Criteria: 1. Subjects must understand and comply with the study procedures, voluntarily participate, and sign the informed consent form. 2. Male subjects must weigh at least 50 kg; female subjects must weigh at least 45 kg. 3. 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. 4. 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. 5. 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. 6. HBV DNA \< 90 IU/mL at screening. 7. HBsAg \> 100 IU/mL at screening. 8. Serum ALT and AST ≤ 2 × ULN, and total serum bilirubin ≤ 2 × ULN at screening and baseline. Exclusion Criteria: 1. Subjects who have undergone major surgery within 3 months prior to screening, or plan to undergo surgery during the study period. 2. 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). 3. 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. 4. 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. 5. 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. 6. Subjects who participated in another clinical trial within 3 months prior to screening. 7. 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. 8. Subjects who are breastfeeding or have a positive serum pregnancy test result. 9. Subjects with significant hepatic fibrosis or liver cirrhosis. 10. 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. 11. Subjects diagnosed with any malignant tumor within 5 years prior to screening , or those assessed to have potential malignant tumors at present. 12. Subjects with international normalized ratio (INR) \>1.5, or platelet count \<90×10⁹/L, or serum albumin \<35 g/L at screening. 13. Subjects with alpha-fetoprotein (AFP) \>50 ng/mL at screening. 14. Subjects with endogenous creatinine clearance (CLcr) \<60 mL/min/1.73 m² at screening. 15. Subjects receiving, or who have received any interferon-containing regimen or immunosuppressive therapy within 1 year prior to screening. 16. Subjects whom the investigator considers unsuitable for participation in this trial for any other reasons.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07771140 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying HBV Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07771140 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07771140 currently recruiting?
Yes, NCT07771140 is actively recruiting participants. Contact the research team at hwgcp@ayefy.com for enrollment information.
Where is the NCT07771140 trial being conducted?
This trial is being conducted at Hefei, China.
Who is sponsoring the NCT07771140 clinical trial?
NCT07771140 is sponsored by Sunshine Lake Pharma Co., Ltd.. The trial plans to enroll 78 participants.