SA1211 Injection Phase 1 Study
ConditionChronic Hepatitis B
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSuzhou Siran Biotechnology Co.,Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- SA1211 injection
- SA1211 injection placebo
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Suzhou Siran Biotechnology Co.,Ltd.
Lead sponsor
Beijing Siran Biotechnology Co.,Ltd.
Collaborator
Source ClinicalTrials.gov