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NCT07847697
A Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, PK/PD Characteristics, and Efficacy of SCTB10
Conditions: Healthy Participants
Sex: Male
Ages: 18 Years – 50 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 12
Sponsor: Sinocelltech Ltd.
Location: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences Tianjin
Summary
Phase Ia to evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of SCTB10 following a single dose in healthy participants
Eligibility Criteria
Inclusion Criteria:
1. Provision of written informed consent prior to initiation of any study procedures.
2. Healthy male participants aged 18 to 50 years (inclusive).
3. Body mass index (BMI) between 19 and 26 kg/m² (inclusive), and body weight ≥ 50 kg.
4. 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 Criteria:
1. History of hypersensitivity or allergy to monoclonal antibodies, or a known atopic constitution.
2. History of coronary and/or peripheral atherosclerosis, or congestive heart failure.
3. Presence of high-risk factors for thrombosis.
4. Clinically significant abnormal findings during screening, as determined by the investigator.
5. Abnormal infectious disease screening results.
6. Abnormal results in urine drug screening or breath alcohol test.
7. Use of any medication or dietary supplements within 14 days prior to the first dose.
8. Participation in another clinical trial involving the use of any investigational drug or medical device within 12 weeks prior to screening.
9. Receipt of any biologic products (including antibodies or their derivatives) within 16 weeks prior to dosing (or within 5 half-lives, whichever is longer).
Source: ClinicalTrials.gov (NCT07847697). StuddyBuddy aggregates publicly available trial information.