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
This trial accepts healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
SK-08
DrugDose groups of 5 mg, 7.5mg,12.5 mg, 30 mg, 45 mg, and 60 mg were given SK-08 once.
Placebo
DrugDose groups of 5 mg, 7.5mg,12.5 mg, 30 mg, 45 mg, and 60 mg were given placebo once.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: SK-08Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Safety Evaluation
The occurrence of AE during the experiment
Time frame
up to Day 12Secondary outcomes
1
PK Evaluation（Cmax）
Pharmacokinetic characteristics after administration (Cmax）
Time frame
within 1 hour pre-dosing and at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.25hour，2.5 hour, 2.75hour，3 hour, 3.5hour，4 hour, 5hour，6 hour, 8 hour, 12 hour, 24 hour , 48 hour, 72 hour and 96hour post-dosing2
PK Evaluation（Tmax）
Pharmacokinetic characteristics after administration
Time frame
within 1 hour pre-dosing and at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.25hour，2.5 hour, 2.75hour，3 hour, 3.5hour，4 hour, 5hour，6 hour, 8 hour, 12 hour, 24 hour , 48 hour, 72 hour and 96hour post-dosing3
PK Evaluation（ AUC0-T）
Pharmacokinetic characteristics after administration (AUC0-T）
Time frame
within 1 hour pre-dosing and at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.25hour，2.5 hour, 2.75hour，3 hour, 3.5hour，4 hour, 5hour，6 hour, 8 hour, 12 hour, 24 hour , 48 hour, 72 hour and 96hour post-dosing4
PK Evaluation ( AUC0-∞）
Pharmacokinetic characteristics after administration ( AUC0-∞）
Time frame
within 1 hour pre-dosing and at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.25hour，2.5 hour, 2.75hour，3 hour, 3.5hour，4 hour, 5hour，6 hour, 8 hour, 12 hour, 24 hour , 48 hour, 72 hour and 96hour post-dosingSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov