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

NCT ID: NCT07021157

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-09
• Study Completion Date: 2025-08-07

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.

Conditions

Chronic Kidney Disease(CKD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

SK-08

Intervention Type: DRUG

Dose groups of 5 mg, 7.5mg,12.5 mg, 30 mg, 45 mg, and 60 mg were given SK-08 once.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Dose groups of 5 mg, 7.5mg,12.5 mg, 30 mg, 45 mg, and 60 mg were given placebo once.

Interventions

SK-08

Dose groups of 5 mg, 7.5mg,12.5 mg, 30 mg, 45 mg, and 60 mg were given SK-08 once.

Intervention Type: DRUG

Placebo

Dose groups of 5 mg, 7.5mg,12.5 mg, 30 mg, 45 mg, and 60 mg were given placebo once.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Consun Pharmaceutical Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital，Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

JIAN LIU, Master

Role: CONTACT

lindaliu87@zju.edu.cn

13958054006

Facility Contacts

JIAN LIU, Master

Role: primary

lindaliu87@zju.edu.cn

13958054006

Other Identifiers

2024-CP-SK08-01

Identifier Type: -

Identifier Source: org_study_id