NCT00432770

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2007

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

April 20, 2007

Status Verified

April 1, 2007

First QC Date

February 6, 2007

Last Update Submit

April 19, 2007

Conditions

Thrombosis

Interventions

ARC1779DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bioanalytical Systems, Inc

Baltimore, Maryland, 21201, United States

Location

Related Publications (2)

  • 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.

    PMID: 30957581DERIVED

  • 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.

    PMID: 18025536DERIVED

MeSH Terms

Conditions

Thrombosis

Interventions

ARC 1779

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 6, 2007

First Posted

February 8, 2007

Study Start

December 1, 2006

Study Completion

March 1, 2007

Last Updated

April 20, 2007

Record last verified: 2007-04

Locations

US(1)