Healthy ParticipantsPhase 1NCT07847697
A Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, PK/PD Characteristics, and Efficacy of SCTB10
A Phase 1 study testing SCTB10 in people with Healthy Participants, run by Sinocelltech Ltd. at 1 site in China.
Trial summary
Phase Ia to evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of SCTB10 following a single dose in healthy participants Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- SCTB10
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2026to 30 Aug 2029
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of written informed consent prior to initiation of any study procedures.
- Healthy male participants aged 18 to 50 years (inclusive).
- Body mass index (BMI) between 19 and 26 kg/m² (inclusive), and body weight ≥ 50 kg.
- Agreement by the participant and their partner to use highly effective contraception during the study period and for 6 months following the last dose of study medication.
Who cannot join
- History of hypersensitivity or allergy to monoclonal antibodies, or a known atopic constitution.
- History of coronary and/or peripheral atherosclerosis, or congestive heart failure.
- Presence of high-risk factors for thrombosis.
- Clinically significant abnormal findings during screening, as determined by the investigator.
- Abnormal infectious disease screening results.
- Abnormal results in urine drug screening or breath alcohol test.
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- Use of any medication or dietary supplements within 14 days prior to the first dose.
- Participation in another clinical trial involving the use of any investigational drug or medical device within 12 weeks prior to screening.
- Receipt of any biologic products (including antibodies or their derivatives) within 16 weeks prior to dosing (or within 5 half-lives, whichever is longer).
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
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin
About this study
Official title: A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Single and Multiple Doses of SCTB10 in Healthy Participants and Patients With Hemophilia A
Phase Ia to evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of SCTB10 following a single dose in healthy participants
- Conditions
- Healthy Participants
- Being tested
- SCTB10, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCTB10Drug
SCTB10 will be subcutaneously administered as a single dose in healthy volunteers
PlaceboDrug
Placebo will be subcutaneously administered in Healthy Volunteers
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
| SCTB10 group | Experimental | Not described Receives: Drug: SCTB10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
dose limited toxicity (DLT).
To determine the maximum tolerated dose (MTD) and/or RP2D.
Measured: Up to approximately 6 weeks.
Incidence of TEAE.
TEAE refers to 'treatment emergent adverse event'.
Measured: Up to approximately 25 weeks.
Incidence of TRAE.
Incidence of TEAE related to the experimental drug.
Measured: Up to approximately 25 weeks.
Incidence of SAE.
SAE refers to 'serious adverse event'.
Measured: Up to approximately 25 weeks
Secondary outcomes (3)
Blood Concentrations of SCTB10
The pharmacokinetics of SCTB10 will be analyzed based on the drug concentrations at respective timepoints in the blood samples (or blood derivative)
Measured: Up to approximately 25 weeks
Activated Partial Thromboplastin Time and Thrombin Generation Assay
pharmacodynamics
Measured: Up to approximately 25 weeks
Incidence of anti-SCTB10 antibody (ADA) and neutralizing antibody (Nab).
immunogenicity
Measured: Up to approximately 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 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
- NCT07847697
- Sponsor's protocol ID
- SCTB10-A201
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Single and Multiple Doses of SCTB10 in Healthy Participants and Patients With Hemophilia A
- ClinicalTrials.gov ID
- NCT07847697
- Acronym / sponsor ID
- SCTB10-A201
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Aug 2029 (estimated)
- First posted
- 29 Sep 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.
Phase Ia to evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of SCTB10 following a single dose in healthy participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: Placebo |
| SCTB10 group | Experimental | Drug: SCTB10 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Provision of written informed consent prior to initiation of any study procedures.
- Healthy male participants aged 18 to 50 years (inclusive).
- Body mass index (BMI) between 19 and 26 kg/m² (inclusive), and body weight ≥ 50 kg.
- Agreement by the participant and their partner to use highly effective contraception during the study period and for 6 months following the last dose of study medication.
Key exclusion criteria (9 listed)
- History of hypersensitivity or allergy to monoclonal antibodies, or a known atopic constitution.
- History of coronary and/or peripheral atherosclerosis, or congestive heart failure.
- Presence of high-risk factors for thrombosis.
- Clinically significant abnormal findings during screening, as determined by the investigator.
- Abnormal infectious disease screening results.
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 |
|---|---|---|
| SCTB10SCTB10 will be subcutaneously administered as a single dose in healthy volunteers | Drug | SCTB10 group |
| PlaceboPlacebo will be subcutaneously administered in Healthy Volunteers | Drug | Placebo group |
Primary outcome
dose limited toxicity (DLT).
Time frame: Up to approximately 6 weeks.
To determine the maximum tolerated dose (MTD) and/or RP2D.
Incidence of TEAE.
Time frame: Up to approximately 25 weeks.
TEAE refers to 'treatment emergent adverse event'.
Incidence of TRAE.
Time frame: Up to approximately 25 weeks.
Incidence of TEAE related to the experimental drug.
Incidence of SAE.
Time frame: Up to approximately 25 weeks
SAE refers to 'serious adverse event'.
3 secondary outcomes
Blood Concentrations of SCTB10
Time frame: Up to approximately 25 weeks
Activated Partial Thromboplastin Time and Thrombin Generation Assay
Time frame: Up to approximately 25 weeks
Incidence of anti-SCTB10 antibody (ADA) and neutralizing antibody (Nab).
Time frame: Up to approximately 25 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 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 SCTB10 in people with Healthy Participants, 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 9 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 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dose limited toxicity (DLT). (time frame: Up to approximately 6 weeks.). The study lists 4 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 Sep 2026.