Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-03-31

Brief Summary

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The purpose of this study is to establish the overall safety and tolerability of ARC1779 in healthy volunteers, and to characterize its pharmacokinetic and pharmacodynamic profile with respect to parameters of platelet function and von Willebrand Factor activity.

Detailed Description

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The purpose of this study is to establish the overall safety and tolerability of ARC1779 in healthy volunteers, and to characterize its pharmacokinetic and pharmacodynamic profile with respect to parameters of platelet function and von Willebrand Factor activity.

Conditions

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Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ARC1779

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ≥ 18 to ≤ 65 years of age
* Weight ≤ 110 kg
* Negative qualitative urine drug/alcohol test
* Female volunteers must be of non-childbearing potential
* Male volunteers must agree to use a medically acceptable contraceptive
* Volunteers must be capable of understanding and complying with the protocol and must have signed the informed consent document

Exclusion Criteria

Any clinically significant medical disorder (e.g. diabetes, hypertension, etc.)

* Tendency to bleed easily
* History of recent trauma or surgery
* History of gout or renal stones

Clinically significant abnormal lab parameters for the following:

* PT INR \> 1.4
* aPTT \> reference laboratory values
* Serum creatinine \> 1.3 mg/dL
* Platelet count of ≤ 100,000/mm3
* ALT/AST \> 2 times ULN
* WBC ≤ 3000 x 109/L
* Hemoglobin \< 11 g/dL
* Total bilirubin \> 1.2 mg/dL
* CBT \> 15 min

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Locations

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Bioanalytical Systems, Inc

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.

Reference Type DERIVED

PMID: 30957581 (View on PubMed)

Gilbert JC, DeFeo-Fraulini T, Hutabarat RM, Horvath CJ, Merlino PG, Marsh HN, Healy JM, Boufakhreddine S, Holohan TV, Schaub RG. First-in-human evaluation of anti von Willebrand factor therapeutic aptamer ARC1779 in healthy volunteers. Circulation. 2007 Dec 4;116(23):2678-86. doi: 10.1161/CIRCULATIONAHA.107.724864. Epub 2007 Nov 19.