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Starting soon Phase 1

Phase Ia/Ib Trial of SCTA02A Injection in Healthy Adults and Patients With Chronic Hepatitis B

NCT07903831 · tracked via the Priya Life Science China tracker
Phase
Phase 1
Started
2026-10
Last updated
2026-10-29

Condition(s) studied

Hepatitis B

Investigational drug(s) / intervention(s)

SCTA02APlacebo

SCTA02A: SCTA02A, an investigational monoclonal antibody.

Placebo: Placebo

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 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 Criteria: * Hypersensitivity or intolerance to immunoglobulin, the active ingredient or excipients of SCTA02A; Any history of severe allergic reactions * History of active infection or fever within 14 days prior to enrollment * Presence of primary disease of major organs * Diagnosis of autoimmune disease * 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 * History of prior malignancy * Major surgical procedure within 3 months prior to screening * Weekly alcohol consumption exceeding 14 standard units within 3 months prior to screening * History of drug or substance abuse

Primary outcome measure(s)

  • Incidence and severity of treatment-related adverse events (TRAEs) after administration.Maximum tolerated dose(MTD) — up to 16 weeks
  • HBsAg change from baseline (Ib) — up to 16 weeks

Trial sites (1)

FacilityCityRegionStatus
Beijing Friendship Hospital, Capital Medical University Beijing Beijing Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07903831 on ClinicalTrials.gov ↗ ← All trials in China