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

Phase 1 Recruiting 48 enrolled Consun Pharmaceutical Group

RandomizedSequentialDouble-blindTreatment

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.

Timeline

Start: 2025-03-09
Primary completion: 2025-08-07
Completion: 2025-08-07

Publications

Liu J, Du Y, Zhou H, Jia H, Zhai Y, Ruan J, Yan C, Xu N, Xin Y, Zheng L, Song Y, Jiang D, Yang J. Safety, pharmacokinetic, and pharmacodynamic characteristics of SK-08, a soluble guanylate cyclase activator, after oral administration in healthy participants: a randomized phase 1 trial. BMC Nephrol. 2026 Jul 9. doi: 10.1186/s12882-026-05138-y. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SK08	Other / unclassified	5 mg	Oral
Subject	SK08	Other / unclassified	7.5 mg	Oral
Subject	SK08	Other / unclassified	12.5 mg	Oral
Subject	SK08	Other / unclassified	30 mg	Oral
Subject	SK08	Other / unclassified	45 mg	Oral
Subject	SK08	Other / unclassified	60 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications