A Study to Evaluate the Safety, Tolerability and PK of SK-08
ConditionChronic Kidney Disease(CKD)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorConsun Pharmaceutical Group
About this trial
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.
Eligibility criteria
Qualifiers
Healthy male and female participants aged 18 to 45 years (inclusive).
Male participants: Body weight ≥50 kg; Female participants: Body weight ≥45 kg; Body mass index (BMI) between 19.0 and 26 kg/m².
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 .
Capable of understanding and voluntarily providing written informed consent prior to any study-related procedures.
Disqualifiers
Have a specific history of allergies or have an allergic constitution；
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.
Developed acute diseases from 2 weeks before screening to before randomization ;
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;
Trial design
Treatments tested in this trial
- SK-08
- Placebo
Treatment groups
48 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov