NCT07903831Not yet recruitingPhase 1
Phase Ia/Ib Trial of SCTA02A Injection in Healthy Adults and Patients With Chronic Hepatitis B
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
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 16 Oct 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Sinocelltech Ltd.
- Diseases
- Hepatitis B
- NCT number
- NCT07903831
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 60
- From 1 Oct 2026 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.