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November 24, 2010Thrombosis and Haemostasis

Phase I study of Solulin, a novel recombinant soluble human thrombomodulin analogue

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Key result

No clinical data is available in the provided text, which consists only of the journal's editorial board information.

Why the study?

Does Solulin demonstrate safety, tolerability, and predictable pharmacokinetics and pharmacodynamics compared to placebo in healthy volunteers?

Population

42 healthy volunteers (30 in single ascending dose group, 12 in multiple ascending dose group)

Comparison

Solulin via single or multiple ascending… vs Placebo

Design

Other

Authors

TIThijs van IerselInteruniversity Center for Social Science Theory and MethodologyHSHeimo StroissnigAlvotech (Germany)PGPeter GiesenYork Hospital

Discussion

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Implication

No clinical data available on Solulin; leaves open its safety and development as anticoagulant.

Structured PICO

Does Solulin demonstrate safety, tolerability, and predictable pharmacokinetics and pharmacodynamics compared to placebo in healthy volunteers?

P
Population
42 healthy volunteers (30 in single ascending dose group, 12 in multiple ascending dose group)
I
Intervention
Solulin (recombinant soluble human thrombomodulin analogue) via single (0.6-30 mg) or multiple (1 and 10 mg) ascending intravenous bolus doses
C
Comparator
Placebo
O
Outcome
Safety, tolerability, pharmacokinetics, and pharmacodynamicssafety

In this first-in-human Phase I study, the novel thrombomodulin analogue Solulin showed a favorable safety profile and predictable pharmacodynamics, supporting its further investigation as an anticoagulant.

Cite This Study

Iersel et al. (2010) studied this question. Solulin was evaluated. No clinical data is available in the provided text, which consists only of the journal's editorial board information.

synapsesocial.com/papers/6a71df87ac440176ef2a63c4https://doi.org/10.1160/th10-05-0287
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Also Consider

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  1. 1Pharmacokinetics and Safety of a Novel Recombinant Soluble Human Thrombomodulin, ART‐123, in Healthy Male Volunteers1998 · 48 citations
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  5. 5The N-terminal domain of thrombomodulin sequesters high-mobility group-B1 protein, a novel antiinflammatory mechanism2005 · 530 citations