Phase Ia to evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of SCTB10 following a single dose in healthy participants
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.
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.
Parallel
SCTB10
DrugSCTB10 will be subcutaneously administered as a single dose in healthy volunteers
Placebo
DrugPlacebo will be subcutaneously administered in Healthy Volunteers
dose limited toxicity (DLT).
To determine the maximum tolerated dose (MTD) and/or RP2D.
Incidence of TEAE.
TEAE refers to 'treatment emergent adverse event'.
Incidence of TRAE.
Incidence of TEAE related to the experimental drug.
Incidence of SAE.
SAE refers to 'serious adverse event'.
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)
Activated Partial Thromboplastin Time and Thrombin Generation Assay
pharmacodynamics
Incidence of anti-SCTB10 antibody (ADA) and neutralizing antibody (Nab).
immunogenicity
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