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Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 in Healthy Volunteers

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00432770
Enrollment
42
Registered
2007-02-08
Start date
2006-12-31
Completion date
2007-03-31
Last updated
2007-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombosis

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.

Interventions

DRUGARC1779

Sponsors

Archemix Corp.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026