ArticleClinical pharmacology in drug development2025
A Phase 1C, Open Label, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of DM199 Administered Intravenously with a Polyvinyl Chloride Bag in Adult Healthy Subjects and Adults Recently Taking Angiotensin-Converting Enzyme Inhibitors.
Article in Clinical pharmacology in drug development, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
6 citing papers in PubMed.
- Safety and tolerability of Rinvecalinase Alfa (DM199) for acute ischemic stroke (ReMEDy1).International journal of stroke : official journal of the International Stroke Society · 2026Trial
- Endothelial triple-pathway vasorelaxation as an adjunctive strategy in resistant hypertension.Journal of hypertension · 2026Review
- Emerging biomarkers in prostate cancer diagnosis and treatment: Insights into genetic, RNA and metabolic markers (Review).International journal of oncology · 2026Review
- Pharmacological characterization and neuroprotective efficacy of ZHB103, a novel long-acting rhKLK1.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026Article
- Article
- Kinin receptors in adipose tissue: drivers of inflammation and metabolic dysfunction in obesity.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2025Review
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Authors and funding
4 authors.
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Abstract
This small phase 1C, open-label, single ascending dose study evaluated the safety, tolerability, and pharmacokinetics (PKs) of DM199, a recombinant form of human tissue kallikrein-1 (KLK1). A small sample size of both healthy subjects and hypertensive adults recently taking angiotensin-converting enzyme inhibitors was studied. KLK1 has a known role in vasodilation and blood flow regulation, with potential implications for treatment of acute ischemic stroke (AIS) by focally enhancing cerebral perfusion. A total of 12 subjects were enrolled; 9 healthy subjects received escalating doses of DM199 (0.1-0.5 µg/kg), while 3 hypertensive subjects received the maximum tolerated dose of 0.5 µg/kg. Safety assessments indicated that DM199 was well tolerated, with mild adverse events reported, such as headache and flushing. No infusion-related hypotensive events occurred, and all subjects completed the study without significant clinical issues. The study was performed following prior PK analyses revealing that DM199 exposure was greater when administered with polyvinyl chloride infusion materials compared with polyolefin infusion materials. This study supports a revised dosing strategy for DM199 in the ongoing ReMEDy2 trial for AIS and highlights the need for careful consideration of the risk-benefit profile in the clinical context of AIS treatment.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.