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Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 in Healthy Volunteers

Primary Purpose

Thrombosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ARC1779
Sponsored by
Archemix Corp.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thrombosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Bioanalytical Systems, Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 6, 2007
Last Updated
April 19, 2007
Sponsor
Archemix Corp.
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1. Study Identification

Unique Protocol Identification Number
NCT00432770
Brief Title
Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 in Healthy Volunteers
Official Title
A Phase 1, Single-Site, Double-Blind,Randomized, Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous Bolus or Intravenous Bolus Followed by Continuous Infusion Administration of ARC1779 Compared to Placebo in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Archemix Corp.

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
42 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ARC1779

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Bioanalytical Systems, Inc
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30957581
Citation
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.
Results Reference
derived
PubMed Identifier
18025536
Citation
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.
Results Reference
derived

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Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 in Healthy Volunteers

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