Early safety study of SCTB10 in healthy adults
Tests SCTB10, a new drug, for safety in healthy adults.
Plain-language title generated from the registry record
Registry title: A Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, PK/PD Characteristics, and Efficacy of SCTB10
Key facts
- Where
- Tianjin, 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 50 years old?
Source: NCT07847697, who can take part
Where in China
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical SciencesTianjin, 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
- NCT07847697
- Record updated
- 10 November 2026
- Original description
Phase Ia to evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of SCTB10 following a single dose in healthy participantsRead full original descriptionShow less
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
Inclusion: 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.
Exclusion: Abnormal results in urine drug screening or breath alcohol test; 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); 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; Abnormal infectious disease screening results; Clinically significant abnormal findings during screening, as determined by the investigator.