Safety of SCTA02A injection in healthy adults and people with chronic hepatitis B
Tests SCTA02A injection for safety in healthy adults and people with hepatitis B.
Plain-language title generated from the registry record
Registry title: Phase Ia/Ib Trial of SCTA02A Injection in Healthy Adults and Patients With Chronic Hepatitis B
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for healthy adults and adults with chronic hepatitis B to test the safety and dosing of the study drug SCTA02A.
- Age
- Healthy volunteers: 18 to 60 years old. People with chronic hepatitis B: 18 to 65 years old.
- Sex
- Men and women can join.
- Disease stage
- Chronic hepatitis B infection, or healthy volunteers with no illness.
- Earlier treatment
- Cannot have used any prescription drugs, over-the-counter drugs or herbal medicines within 7 days before dosing. Cannot have had a vaccination within 30 days before screening. Cannot have been in another drug or device trial within 3 months before screening.
Main reasons for not taking part
- Allergy or intolerance to immunoglobulin or to SCTA02A ingredients, or any history of severe allergic reactions
- Active infection or fever within 14 days before enrollment
- Primary disease of a major organ, or an autoimmune disease
- History of cancer
- Major surgery within 3 months before screening, or a history of drug or substance abuse
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07903831, who can take part
Where in China
- Beijing Friendship Hospital, Capital Medical UniversityBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Sinocelltech Ltd.
- Trial code
- NCT07903831
- Record updated
- 29 October 2026
- Original description
Study SCTA02A-A101 is designed to assess the safety, tolerability and pharmacokinetics of SCTA02A in healthy volunteers and participants with chronic hepatitis B virus infection. Eligible participants will receive study treatment in this phase 1 dose-escalation study. All treated patients will also undergo a safety follow-up period after last study drug administration.Read full original descriptionShow less
A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase Ia/Ib Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of SCTA02A Injection in Healthy Adults and Patients With Chronic Hepatitis B
Study SCTA02A-A101 is designed to assess the safety, tolerability and pharmacokinetics of SCTA02A in healthy volunteers and participants with chronic hepatitis B virus infection. Eligible participants will receive study treatment in this phase 1 dose-escalation study. All treated patients will also undergo a safety follow-up period after last study drug administration.
Inclusion: Healthy volunteers: 18 to 60 years old (inclusive); Participants with chronic hepatitis B: 18 to 65 years old (inclusive); Sex: male or female; Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI): 18 kg/m² ≤ BMI ≤ 28 kg/m².
Exclusion: History of active infection or fever within 14 days prior to enrollment; Use of any prescription drugs, over-the-counter drugs, or herbal medicines within 7 days prior to dosing; Participation in another clinical trial of investigational drug or medical device within 3 months prior to screening; Vaccination within 30 days prior to screening; Major surgical procedure within 3 months prior to screening; Weekly alcohol consumption exceeding 14 standard units within 3 months prior to screening; Hypersensitivity or intolerance to immunoglobulin, the active ingredient or excipients of SCTA02A; Any history of severe allergic reactions; Presence of primary disease of major organs; Diagnosis of autoimmune disease; History of prior malignancy; History of drug or substance abuse.