January 1, 1998The Journal of Clinical Pharmacology

Pharmacokinetics and Safety of a Novel Recombinant Soluble Human Thrombomodulin, ART‐123, in Healthy Male Volunteers

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Why the study?

What are the safety and pharmacokinetic properties of ART-123 in healthy male volunteers?

Structured PICO

What are the safety and pharmacokinetic properties of ART-123 in healthy male volunteers?

Population

16 healthy male volunteers

Intervention

ART-123 (recombinant soluble human thrombomodulin) administered by intravenous infusion over 2 hours (single doses of 0.03, 0.1, and 0.3 mg; multiple doses of 0.2 mg once daily for 3 days)

Outcome

Safety and pharmacokinetics (plasma concentration, half-life, urinary recovery)safety

ART-123, a novel recombinant soluble human thrombomodulin, demonstrates a favorable safety and pharmacokinetic profile in healthy male volunteers, supporting further clinical development.

Limitations

Further studies are needed to evaluate the safety and pharmacokinetics of ART-123 in the targeted population

Discussion

No takes yet. Share an insight, caveat, or question.

Implication

Supports dose selection for trials; leaves open efficacy and safety in target populations.

Cite This Study

Nakashima et al. (1998) studied this question.

synapsesocial.com/papers/6a7717a31400807f0f1e86fe https://doi.org/10.1002/j.1552-4604.1998.tb04375.x

View Full Paper

Ask AI

Bookmark

Pharmacokinetics and Safety of a Novel Recombinant Soluble Human Thrombomodulin, ART‐123, in Healthy Male Volunteers

Structured PICO

Limitations

Discussion

Implication

Cite This Study

Pharmacokinetics and Safety of a Novel Recombinant Soluble Human Thrombomodulin, ART‐123, in Healthy Male Volunteers

Structured PICO

Limitations

Discussion

Implication

Cite This Study

Also Consider

Also Consider