A Study to Evaluate the Safety, Tolerability and PK of SK-08

Phase 1

Recruiting

• Conditions: Chronic Kidney Disease(CKD)
• Interventions: Drug: SK-08; Drug: Placebo

• Registration Number: NCT07021157
• Lead Sponsor: Consun Pharmaceutical Group

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.

Study Timeline

• Study Start: 2025-03-09
• Status Verified: 2025-05
• Study First Submitted: 2025-05-12
• Study First Submitted QC: 2025-06-06
• Study First Posted: 2025-06-13
• Last Update Submitted: 2025-06-18
• Last Update Posted: 2025-06-24
• Primary Completion: 2025-08-07
• Study Completion: 2025-08-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
SK-08	SK-08	Seven sequential dose groups（A1-A7） will be evaluated: 5 mg, 7.5mg,12.5 mg, 20 mg, 30 mg, 45 mg, and 60 mg. SK-08 were given once for 5mg, 7.5mg,12.5 mg, 30 mg, 45 mg, and 60 mg dose groups.
Placebo	Placebo	Seven sequential dose groups（A1-A7） will be evaluated: 5 mg, 7.5mg,12.5 mg, 30 mg, 45 mg, and 60 mg. Placebo were given once for 5mg, 7.5mg,12.5 mg, 30 mg, 45 mg, and 60 mg dose groups.

Primary Outcome Measures

Name	Time	Method
Safety Evaluation	up to Day 12	The occurrence of AE during the experiment

Secondary Outcome Measures

Name	Time	Method
PK Evaluation（Cmax）	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	Pharmacokinetic characteristics after administration (Cmax）
PD Evaluation（changes in cGMP concentration levels）	within 1.00 hour pre-dosing and 0.50 hour, 1hour,1.5hour,2hour,2.5hour,3hour,4hour,5hour,6hour,8hour,12hour post-dosing	changes in cGMP concentration levels
PK Evaluation（Tmax）	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	Pharmacokinetic characteristics after administration
PK Evaluation（ AUC0-T）	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	Pharmacokinetic characteristics after administration (AUC0-T）
PK Evaluation ( AUC0-∞）	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	Pharmacokinetic characteristics after administration ( AUC0-∞）
PD Evaluation（Heart rate）	within 1.0hour pre-dosing, and at 1.0hour, 2.0hour, 4.0hour, 6.0h, and 12.0h post dosing	Heart rate
PD Evaluation（blood pressure）	within 1.0hour pre-dosing, and at 1.0hour, 2.0hour, 4.0hour, 6.0h, and 12.0h post dosing	blood pressure
QT interval analysis indicators（QTcF）	With in1hour pre-dosing,and at 0.5hour、1.0hour、1.5hour、2.0hour、4.0hour、6.0hour、12.0hour、24.0hour post-dosing	QTcF
QT interval analysis indicators（ΔQTcF）	With in1hour pre-dosing,and at 0.5hour、1.0hour、1.5hour、2.0hour、4.0hour、6.0hour、12.0hour、24.0hour post-dosing	ΔQTcF

Trial Locations

Locations (1)

The First Affiliated Hospital，Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China