This Phase I study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and cytokine profiles of LYNC-101 for Injection in healthy adult participants. The study consists of 2 parts: Part 1 is a single ascending dose (SAD) study and Part 2 is a multiple ascending dose (MAD) study. In Part 1, participants will receive a single intravenous infusion of LYNC-101 for Injection or placebo across sequential ascending dose cohorts. In Part 2, participants will receive intravenous infusions of LYNC-101 for Injection or placebo once every 3 weeks for a total of 3 doses across sequential ascending dose cohorts.
Healthy male or female participants aged 18-60 years (inclusive).
Body weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI) of 18-32 kg/m² (inclusive).
Able to fully understand the study, voluntarily agree to participate in the study, and sign the informed consent form.
Participants agree to have no plans for conception, sperm donation, or egg donation from the date of signing the informed consent form until 3 months after the last dose and must use effective non-pharmacological contraception with partners of childbearing potential.
Participants with clinically significant abnormalities (as judged by the PI or delegate) in vital signs, physical examinations, laboratory tests, or 12-lead ECG during the screening period.
Participants with positive test result for any of the following: hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or treponema pallidum-specific antibody (TP-Ab).
Participants with history or current presence of any clinically significant disease or disorder of the circulatory, endocrine, metabolic, urinary, digestive, dermatologic, hematologic, nervous, or psychiatric systems, which, as assessed by the Investigator, precludes safe participation in the study.
History of childhood asthma (regardless of resolution), depression, migraine, or Gilbert's Syndrome. Note: Participants with a history of cholecystectomy are eligible for inclusion.
Sequential
LYNC-101
DrugSAD:Administered as a single dose via intravenous infusion. MAD:Administered via intravenous infusion every 3 weeks.
LYNC-101 Placebo
DrugLYNC-101 Placebo SAD:Administered as a single dose via intravenous infusion. MAD:Administered via intravenous infusion every 3 weeks.
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Treatment groupsSee each treatment group below.
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs)
Changes in 12-lead electrocardiogram parameters (ECG QT Interval, etc)
Heart rate (HR), PR interval, QT interval, QRS interval, and QTcF interval should be recorded. During the screening period, if an abnormal corrected QT interval (QTcF) is determined by the Investigator, it may be re-measured up to 2 times, with a recommended interval of at least 5 minutes between each measurement, and the average QTcF value of the three measurements should be calculated. QTcF = QT/(RR\^0.33), RR = 60 / HR. During the study, the Investigator will determine whether a repeat measurement is necessary.
Changes in vital signs (Number of participants with treatment-related adverse events as assessed by CTCAE v6.0)
Including sitting blood pressure, respiration, pulse, and body temperature (axillary, tympanic, or forehead temperature are all acceptable, but participants at the same study site must use a consistent method). Vital signs will be measured at the times specified in the study schedule. Additional vital sign tests may be performed during the study if abnormalities are clinically significant.
Changes in physical examination findings (Number of participants with treatment-related adverse events as assessed by CTCAE v6.0)
Physical examinations will be conducted according to the study assessment schedule. Comprehensive physical examinations include general condition (including overall appearance, skin, mucous membranes, lymph nodes, etc.), head, neck, chest, abdomen, spine and extremities, and nervous system, and other.
Maximum observed plasma concentration (Cmax) of LYNC-101
Time to maximum observed plasma concentration (Tmax) of LYNC-101
Area under the plasma concentration-time curve from time 0 to 504 hours (AUC0-504h)
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t)
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