NCT07021157

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Consun Pharmaceutical Group · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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)

Interventions

Type	Name	Description
DRUG	SK-08	Dose groups of 5 mg, 7.5mg,12.5 mg, 30 mg, 45 mg, and 60 mg were given SK-08 once.
DRUG	Placebo	Dose groups of 5 mg, 7.5mg,12.5 mg, 30 mg, 45 mg, and 60 mg were given placebo once.

Timeline

• Start date: 2025-03-09
• Primary completion: 2025-08-07
• Completion: 2025-08-07
• First posted: 2025-06-13
• Last updated: 2025-06-24

Locations

1 site across 1 country: China