Safety, tolerability, and how the body handles SK-08 in healthy adults

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

This will test whether SK-08 is safe, well tolerated, and how the body processes it in healthy adults aged 18–45.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Consun Pharmaceutical Group (Industry-sponsored)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07021157 on ClinicalTrials.gov

What this trial studies

This Phase 1, single-center, randomized, double-blind, placebo-controlled, dose-escalation trial plans to enroll up to 48 healthy volunteers across seven predefined dose cohorts (A1–A7). Participants will be randomized to receive SK-08 or placebo with blinded dosing and close safety monitoring. Serial blood sampling will characterize pharmacokinetics and pharmacodynamics, and adverse events and laboratory tests will evaluate tolerability. Findings will inform safe dose ranges and timing for subsequent patient trials in chronic kidney disease.

Who should consider this trial

Good fit: Healthy men and women aged 18–45 with BMI 19.0–26 kg/m² (minimum weight 50 kg for men, 45 kg for women), willing to use effective contraception and attend site visits, are eligible.

Not a fit: People with chronic or severe medical conditions (including existing kidney disease), pregnant or breastfeeding individuals, and those outside the specified age, weight, or BMI ranges are excluded and not expected to benefit directly.

Why it matters

Potential benefit: If successful, the trial could identify safe dose levels and how SK‑08 behaves in the body, enabling later patient studies that might lead to a new treatment option for chronic kidney disease.

How similar studies have performed: There are no published clinical results for SK‑08 specifically, and this standard first-in-human Phase 1 approach has produced mixed outcomes for other early CKD drug candidates.

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.

Where this trial is running

Hangzhou, Zhejiang

• The First Affiliated Hospital，Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: JIAN LIU, Master

Conditions Chronic Kidney Disease