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
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?
Trial 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.