Trial reportBMC nephrology2026
Safety, pharmacokinetic, and pharmacodynamic characteristics of SK-08, a soluble guanylate cyclase activator, after oral administration in healthy participants: a randomized phase 1 trial.
Trial report in BMC nephrology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07021157 (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), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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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
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13 authors.
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Abstract
backgroundUncoupling of the nitric oxide (NO)-soluble guanylate cyclase (sGC)-cyclic guanosine monophosphate (cGMP) axis and impaired cGMP synthesis are hallmarks of chronic kidney disease (CKD). While sGC has been a target of therapeutic interest for CKD, clinical progress has been limited.
methodsIn this single center, phase 1 study (NCT07021157), the pharmacokinetics (PK), pharmacodynamics (PD), and safety of SK-08, a novel, oral sGC activator, were evaluated. Healthy participants were randomized to SK-08 or placebo in the single-ascending-dose phase; in the food-effect phase, SK-08 10 mg was administered under fasted and fed conditions. cGMP was the key PD biomarker, and exposure-response analyses were performed.
resultsBetween 18th March 2025-17th June 2025, 16 participants were randomized and received SK-08 5 mg (n = 3), 7.5 mg (n = 3), or 10 mg (n = 6), or placebo (n = 4). Adverse events (AEs) were mild/moderate and resolved spontaneously, those with an incidence > 10% were hypotension (4/12, 33.3%) and dizziness (2/12, 16.7%). A higher C
conclusionsSK-08 was well tolerated in healthy participants and induced dose-related sGC activation. A potential association between C
trial registrationChinadrugtrials.org.cn (CTR20250337). Registered 20,250,126 Clinicaltrials.gov (NCT07021157). Registered 20,250,512.
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