a study to evaluate the safety, tolerability and pk of sk-08

Conditions: Chronic Kidney Disease(CKD)

Summary: the trial is conducted in a single-center, randomized, double-blind, placebo-controlled, dose-increasing design. to evaluate the safety, tolerability, pharmacokinetics(pk) ,and pharmacodynamics (pd) characteristics of sk-08 in healthy participants.

the trial is conducted in a single-center, randomized, double-blind, placebo-controlled, dose-increasing design. to evaluate the safety, tolerability, pharmacokinetics(pk) ,and pharmacodynamics (pd) characteristics of sk-08 in healthy participants. seven dose groups (a1 to a7) were preset. a total of 48 healthy subjects were planned to be enrolled.

Eligibility criteria:
inclusion criteria: 1. healthy male and female participants aged 18 to 45 years (inclusive). 2. male participants: body weight ≥50 kg; female participants: body weight ≥45 kg; body mass index (bmi) between 19.0 and 26 kg/m². 3. participants must have no plans for conception during the trial and for 3 months after the last dose, and must voluntarily use effective contraception with no plans for sperm or egg donation . 4. capable of understanding and voluntarily providing written informed consent prior to any study-related procedures. exclusion criteria: 1. have a specific history of allergies or have an allergic constitution； 2. have a history of chronic diseases or severe diseases in the cardiovascular, liver, kidney, biliary tract, respiratory, blood and lymphatic, endocrine, immune, mental, neuromuscular, gastrointestinal systems, etc. 3. developed acute diseases from 2 weeks before screening to before randomization ; 4. patients with previous or current hypotension or insufficient blood volume, intracranial hypertension or cerebral hemorrhage, or those with ocular diseases (such as angle-closure glaucoma), who are not suitable for inclusion after assessment by the researcher; 5. those with clinical significance hypokalemia, hyperkalemia, hypomagnesemia, hypermagnesemia, hypocalcemia, and hypercalcemia; 6. those who have used any drugs or health supplements from 2 weeks before screening to randomization ; 7. any drugs that may interact with this product have been used from 30 days before screening to randomization, such as cyp450 inhibitors or inducers ; 8. those who have undergone major surgical operations from 6 months before screening , or who plan to undergo surgery during the study period, or who have undergone surgeries as judged by the investigator to affect drug absorption, distribution, metabolism, and excretion; 9. those who have received live attenuated vaccine inoculation from 2 weeks before screening to randomization or those who need to receive live attenuated vaccine inoculation during the trial; 10. those who had a history of alcohol abuse within one year before screening； 11. those who smoked more than 5 cigarettes per day on average within 3 months before screening and before randomization, or were unable to stop using any tobacco products during the trial period; 12. those who cannot tolerate venipuncture/indwelling needles or have a history of fainting from needles or blood ; 13. other researchers determined that the subjects were not suitable to participate.

Keywords: chronic kidney disease(ckd)