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Recruiting NCT07275918

SA1211 Injection Phase 1 Study

Phase I Interventional Chronic Hepatitis B

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SA1211 injection, SA1211 injection placebo.
Who it may be relevant to
Registry conditions: Chronic Hepatitis B. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SA1211 Injection in Healthy Participants and Participants With Chronic Hepatitis B

Overview

The goal of this clinical trial is to evaluate the safety, tolerability, immunogenicity and Pharmacokinetics (PK) characteristics of SA1211 Injection in healthy volunteers (Part A) and participants with chronic hepatitis B (CHB, Part B), and assess its preliminary efficacy in participants with chronic hepatitis B (CHB). The main questions it aims to answer are: What are the safety, tolerability, immunogenicity and PK characteristics of a single subcutaneous injection of SA1211 Injection in healthy volunteers (Part A)? What are the safety, tolerability, immunogenicity and PK characteristics of multiple subcutaneous injections of SA1211 Injection in participants with CHB (Part B)? What is the preliminary efficacy of SA1211 Injection in participants with CHB (Part B)? Participants will: * Part A (healthy volunteers): Receive a single subcutaneous injection of SA1211 Injection or placebo and complete relevant safety, tolerability and PK monitoring as required. * Part B (participants with CHB): Receive multiple subcutaneous injections of SA1211 Injection or placebo and complete relevant safety, tolerability, PK monitoring and preliminary efficacy assessment as required.

Interventions

  • Drug SA1211 injection
    subcutaneous injection
  • Drug SA1211 injection placebo
    subcutaneous injection

Primary outcome measures

  • Number of participants with AEs, SAEs and abnormal laboratory testings [Time frame: Approximate 24 weeks]
Secondary outcome measures (12)
  • Cmax: maximum concentration [Time frame: Pre-dose, multiple time-points post dose until 48 hours]
  • Tmax [Time frame: Pre-dose, multiple time-points post dose until 48 hours]
  • AUC0-t [Time frame: Pre-dose, multiple time-points post dose until 48 hours]
  • AUC0-inf [Time frame: Pre-dose, multiple time-points post dose until 48 hours]
  • t1/2 [Time frame: Pre-dose, multiple time-points post dose until 48 hours]
  • λz [Time frame: Pre-dose, multiple time-points post dose until 48 hours]
  • Vd/F [Time frame: Pre-dose, multiple time-points post dose until 48 hours]
  • CL/F [Time frame: Pre-dose, multiple time-points post dose until 48 hours]
  • Css (Steady-State Concentration) [Time frame: Pre-dose, multiple time-points post dose until 48 hours]
  • DF (Degree of Fluctuation) [Time frame: Pre-dose, multiple time-points post dose until 48 hours]
  • The number of participants with chronic hepatitis B (CHB) who achieved hepatitis B surface antigen (HBsAg) clearance [Time frame: Approximate 24 weeks]
  • Maximum HBsAg Decline in CHB Participants Within 24 Weeks (log10) [Time frame: Approximate 24 weeks]

Eligibility criteria

Inclusion criteria

  • Able to correctly understand and sign the informed consent form in writing.
  • Male or female participants.
  • For healthy participants: aged 18-55 years old (inclusive of the cut-off values).
  • For participants with chronic hepatitis B (CHB): aged 18-65 years old (inclusive of the cut-off values).
  • Body Mass Index (BMI) meets the following requirements.
  • For healthy participants: within the range of 18-28 kg/m² (inclusive of the cut-off values).
  • For participants with chronic hepatitis B (CHB): within the range of 18-32 kg/m² (inclusive of the cut-off values).
  • During the screening period, the results of the following examinations are either normal or abnormal but not clinically insignificant:

\- Clinical laboratory tests: complete blood count, blood biochemistry, coagulation function, urine routine. Thyroid function test. 12-lead electrocardiogram (ECG). Abdominal ultrasound. Posteroanterior chest X-ray.

  • For participants with chronic hepatitis B (CHB): documented hepatitis B virus (HBV) infection for at least 6 months before screening, with positive hepatitis B surface antigen (HBsAg) and/or positive HBV deoxyribonucleic acid (HBV DNA).
  • For female participants of childbearing potential: must not be pregnant or lactating, and agree to use effective contraception during the study period.
  • For male participants of childbearing potential: agree to use effective contraception during the study period to ensure effective contraception for their sexual partners.

Exclusion criteria

  • Participants with concurrent hepatitis C virus (HCV), human immunodeficiency virus (HIV) or syphilis infection; or those previously diagnosed with hepatitis A, D, or E who have not been cured.
  • Participants with severe diseases, including but not limited to diseases of the nervous, cardiovascular, hematological and lymphatic, immune, renal, hepatic, thyroid, gastrointestinal, respiratory, metabolic, and skeletal systems, as well as a history of malignant tumors.
  • Participants with severe mental illness or uncontrolled mental disorders, including but not limited to schizophrenia, bipolar disorder, or depression.
  • Participants with a systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg at screening, who are deemed unsuitable for the study by the investigator.
  • Participants who have undergone major surgery within 6 months before screening, or plan to undergo surgery during the study period.
  • Participants with severe infection or trauma within 4 weeks before screening.
  • Participants with a severe allergic constitution, or a confirmed allergy to this product or its formulation components.
  • Participants who smoked more than 5 cigarettes per day or the equivalent amount of tobacco within 3 months before screening.
  • Participants deemed unsuitable for the trial by the investigator due to other factors.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Hospital of Jilin University — Changchun

Identifiers

NCT: NCT07275918 · SAHB101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗