Clinical trial NCT07021157: A Study to Evaluate the Safety, Tolerability and PK of SK-08
Official title: A Randomized, Double-blind, Placebo-controlled, Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of Single-dose Increasing of SK-08 Tablets in Healthy Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Chronic Kidney Disease(CKD)
Keywords: Chronic Kidney Disease(CKD)
Lead sponsor: Consun Pharmaceutical Group
Sponsor class: INDUSTRY
First posted: 2025-06-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Primary outcomes:
measure: Safety Evaluation
timeFrame: up to Day 12
Secondary outcomes:
measure: PK Evaluation（Cmax）
timeFrame: 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-dosing
measure: PK Evaluation（Tmax）
timeFrame: 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-dosing
measure: PK Evaluation（ AUC0-T）
timeFrame: 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-dosing
measure: PK Evaluation ( AUC0-∞）
timeFrame: 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-dosing
measure: PD Evaluation（Heart rate）
timeFrame: within 1.0hour pre-dosing, and at 1.0hour, 2.0hour, 4.0hour, 6.0h, and 12.0h post dosing
measure: PD Evaluation（blood pressure）
timeFrame: within 1.0hour pre-dosing, and at 1.0hour, 2.0hour, 4.0hour, 6.0h, and 12.0h post dosing
measure: PD Evaluation（changes in cGMP concentration levels）
timeFrame: within 1.00 hour pre-dosing and 0.50 hour, 1hour,1.5hour,2hour,2.5hour,3hour,4hour,5hour,6hour,8hour,12hour post-dosing
measure: QT interval analysis indicators（QTcF）
timeFrame: With in1hour pre-dosing,and at 0.5hour、1.0hour、1.5hour、2.0hour、4.0hour、6.0hour、12.0hour、24.0hour post-dosing
measure: QT interval analysis indicators（ΔQTcF）
timeFrame: With in1hour pre-dosing,and at 0.5hour、1.0hour、1.5hour、2.0hour、4.0hour、6.0hour、12.0hour、24.0hour post-dosing
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: The First Affiliated Hospital，Zhejiang University
state: Zhejiang
Study officials:
References: