This study is designed to evaluate the safety, tolerability, PK and PD of GenSci136 in a randomized, double-blind, placebo-controlled trial involving healthy adult participants.
Male or female, aged 18 to 45 years (both inclusive) at the time of signing informed consent form (ICF).
Male body weight ≥ 50 kg or female body weight ≥ 45 kg; BMI between 18-28 kg/m2 (both inclusive) at screening.
Males of reproductive age and females of childbearing potential must agree to take highly effective contraceptive methods from screening to the end of the study, and have no plans for conception, sperm donation, or egg donation; females of childbearing potential must have a negative pregnancy test at screening/baseline period and are not breastfeeding.
Able to understand the trial procedures, voluntarily participate in the trial, understand and voluntarily sign the ICF, be able to follow all the trial requirements and complete the study.
Known hypersensitivity to GenSci136 or any of the excipients contained in the GenSci136 formulation, or history of serious hypersensitivity reactions to any drug, compound, food, or other substance, or an allergic constitution.
Presence of tattoo, sunburn, scar or any other factors that may interfere with the assessment of the injection site at the intended injection area.
A history or presence of other significant metabolic, dermatologic, hepatic, renal, hematologic, cardiovascular, gastrointestinal, psychoneurological, respiratory, and/or other major disease that, in the opinion of the investigator, would affect the evaluation of the study.
Any major surgery within 3 months before screening, plan to undergo elective surgery during the study period, or have a history of any surgery that may affect the absorption, distribution, metabolism or excretion of the IMP.
Parallel
GenSci136
DrugAdministered SC.
Placebo
DrugAdministered SC.
● Incidence and severity of treatment-emergent adverse events (TEAEs) ● Incidence and severity of serious adverse events (SAEs)
Serum Concentration of free GenSci136/total GenSci136
Serum concentrations at different time points will be listed and summarized by descriptive statistics.
Maximum serum concentration (Cmax)
PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above.
Time to maximum serum concentration (Tmax)
PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above.
Area under the concentration-time curve from the time zero to last measurable concentration (AUC0-t)
PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above.
Click on the lead sponsor to view all of their trials.
