Hepatitis BPhase 1NCT07903831
Phase Ia/Ib Trial of SCTA02A Injection in Healthy Adults and Patients With Chronic Hepatitis B
A Phase 1 study testing SCTA02A in people with Hepatitis B, run by Sinocelltech Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- SCTA02A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Jia, +86 10-63138585, jiabfhtrial@163.com
Dong, +86 10-63138585
About this study
Official title: 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.
Read the detailed description
SCTA02A, a hepatitis B virus neutralizing monoclonal antibody. This Phase I dose-escalation study consists of two parts: Part Ia is a single ascending dose study in healthy volunteers with 24 participants; Part Ib is a multiple ascending dose study in participants with chronic HBV infection with 36 participants, and will assess preliminary efficacy.
- Conditions
- Hepatitis B
- Being tested
- SCTA02A, Placebo
- Keywords
- Chronic Hepatitis B
- Medical subject headings
- Hepatitis B, Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCTA02ABiological
SCTA02A, an investigational monoclonal antibody.
PlaceboBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| SCTA02A | Experimental | Not described Receives: Biological: SCTA02A |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-related adverse events (TRAEs) after administration.Maximum tolerated dose(MTD)
Measured: up to 16 weeks
HBsAg change from baseline (Ib)
Measured: up to 16 weeks
Secondary outcomes (8)
Maximum Plasma Concentration (Cmax)
Measured: up to 16 weeks
Time to Reach Maximum Plasma Concentration (Tmax)
Measured: up to 16 weeks
Apparent Terminal Elimination Half-life (t1/2)
Measured: up to 16 weeks
Immunogenicity: ADA
Measured: up to 16 weeks
Incidence and severity of adverse events (AE) , serious adverse events (SAE) and adverse events of special interest (AESI)
Measured: up to 16 weeks
HBV DNA change from baseline (Ib)
Measured: up to 16 weeks
proportion of HBV DNA < LLOQ (Ib)
Measured: up to 16 weeks
ALT change from baseline (Ib)
Measured: up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Sinocelltech Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinocelltech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903831
- Sponsor's protocol ID
- SCTA02A-A101
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07903831
- Acronym / sponsor ID
- SCTA02A-A101
- Conditions
- Hepatitis B
- Keywords
- Chronic Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
SCTA02A, a hepatitis B virus neutralizing monoclonal antibody. This Phase I dose-escalation study consists of two parts: Part Ia is a single ascending dose study in healthy volunteers with 24 participants; Part Ib is a multiple ascending dose study in participants with chronic HBV infection with 36 participants, and will assess preliminary efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCTA02A | Experimental | Biological: SCTA02A |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCTA02ASCTA02A, an investigational monoclonal antibody. | Biological | SCTA02A |
| PlaceboPlacebo | Biological | Placebo |
Primary outcome
Incidence and severity of treatment-related adverse events (TRAEs) after administration.Maximum tolerated dose(MTD)
Time frame: up to 16 weeks
HBsAg change from baseline (Ib)
Time frame: up to 16 weeks
8 secondary outcomes
Maximum Plasma Concentration (Cmax)
Time frame: up to 16 weeks
Time to Reach Maximum Plasma Concentration (Tmax)
Time frame: up to 16 weeks
Apparent Terminal Elimination Half-life (t1/2)
Time frame: up to 16 weeks
Immunogenicity: ADA
Time frame: up to 16 weeks
Incidence and severity of adverse events (AE) , serious adverse events (SAE) and adverse events of special interest (AESI)
Time frame: up to 16 weeks
HBV DNA change from baseline (Ib)
Time frame: up to 16 weeks
proportion of HBV DNA < LLOQ (Ib)
Time frame: up to 16 weeks
ALT change from baseline (Ib)
Time frame: up to 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SCTA02A in people with Hepatitis B, run by Sinocelltech Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lili Ma (+86 10-58628288, lili_ma@sinocelltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-related adverse events (TRAEs) after administration.Maximum tolerated dose(MTD) (time frame: up to 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.