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

Consun Pharmaceutical Group

Status and phase: Enrolling; Phase 1

Conditions: Chronic Kidney Disease(CKD)

Treatments: Drug: Placebo; Drug: SK-08

Study type: Interventional

Funder types: Industry

Identifiers

NCT07021157

2024-CP-SK08-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

---

48 participants in 2 patient groups, including a placebo group

SK-08

Experimental group

Description:

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.

Treatment:

Drug: SK-08

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo