Phase 1 Single Ascending Doses(SAD): Six cohorts of 53 healthy volunteers (HVs) will receive a single IV bolus injection of study drug or placebo.
Phase 1 Multiple Ascending Doses(MAD): Three cohorts of 30 HVs will receive multiple IV bolus injections of study drug or placebo every day. After 7 days of continuous administration, the safety, tolerance and Pharmacokinetic/Pharmacodynamic characteristics of multiple administrations were evaluated.
Male and female participants aged between 18 and 55 years inclusive (as of the time of signing the informed consent form);
Male participants with body weight ≥ 50 kg and female participants with body weight ≥ 45 kg, with a body mass index (BMI) ranging from 19 to 26 kg/m² (inclusive of boundary values);
Participants and their partners have no plans for conception, sperm donation or oocyte donation from signing the informed consent form until 2 months after the last dose of study drug, and are willing to adopt highly effective contraceptive measures;
Female participants: not pregnant or breastfeeding; female participants of child-bearing potential must have negative serum pregnancy test results at screening and baseline visits;
Subjects with previous or current clinical acute or chronic diseases including but not limited to cardiovascular, endocrine-metabolic, neuropsychiatric, digestive, respiratory, hematopoietic-lymphoid, immune, urinary, musculoskeletal diseases and malignant tumors, who are judged unsuitable for enrollment by the investigator;
Subjects with personal or family history of hereditary angioedema;
Subjects who have undergone major surgery within 6 months prior to screening, or plan to receive surgical operations during the trial;
Subjects who have taken any medicines or health supplements (including Chinese herbal medicines) within 14 days before dosing; or those who are known to require other drug treatments during the trial at screening.
Parallel
KR25102 for Injection
DrugIntravenous injection of KR25102 for Injection at different dose levels in SAD and MAD cohorts.
Placebo for KR25102 for Injection
DrugIntravenous injection of matching placebo.
Incidence and Severity of Adverse Events (AEs)
including vital signs, physical examination (neurological examination and injection-site examination included), 12-lead electrocardiogram, laboratory tests, abdominal ultrasonography, etc.
Single-Dose Pharmacokinetic (PK) Parameters
AUC₀-ₜ
Single-Dose Pharmacokinetic (PK) Parameters
AUC₀-inf
Single-Dose Pharmacokinetic (PK) Parameters
Tmax
Single-Dose Pharmacokinetic (PK) Parameters
Tlag
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