Trial reportDrug design, development and therapy2026
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Administration JMKX003142 in Chinese Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled, Single, and Multiple Ascending Dose Phase I Clinical Trial.
Trial report in Drug design, development and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06344533 (Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003142 Injection Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Doses in Chinese Healthy Adult Subjects), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003142 Injection Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Doses in Chinese Healthy Adult Subjects
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12 authors.
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Abstract
Purpose: This study is the first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) profiles of single ascending doses (SAD) and multiple ascending doses (MAD) of JMKX003142 injection in healthy Chinese subjects. Patients and Methods: In this Phase I, randomized, double-blind, placebo-controlled study, 48 subjects in the SAD (0.1-6 mg) study received intravenous injection of JMKX003142 or placebo in ascending dose. Thirty subjects in the MAD (1-4 mg) study received an intravenous injection of JMKX003142 or placebo once a day for five consecutive days. The primary endpoint was the safety and tolerability of JMKX003142 injection, with the secondary and exploratory endpoints focusing on its PK and PD profiles, respectively. Results: The JMKX003142 injection exhibited favourable safety and tolerability, with all treatment-emergent adverse events (TEAEs) being mild. No serious adverse events, deaths or discontinuations due to TEAEs were observed. Following single and multiple intravenous injections of JMKX003142, the maximum concentration (C Conclusion: Overall, both single and multiple intravenous injections of JMKX003142 have been demonstrated to be safe, well tolerated, and to possess excellent PK characteristics as well as significant diuretic activity. Trial Registration: This study was registered with ClinicalTrials.gov (NCT06344533).
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