ThrombosisPhase 1NCT00432770
Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 in Healthy Volunteers
A Phase 1 study testing ARC1779 in people with Thrombosis, run by Archemix Corp. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Thrombosis
- What is being tested?
- ARC1779
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Mar 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Bioanalytical Systems, Inc
Baltimore, Maryland, 21201
About this study
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
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.
Read the 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.
- Conditions
- Thrombosis
- Being tested
- ARC1779
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARC1779Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2007 (estimated)
- Study startDec 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 42 participants
Sponsor and investigators
- Lead sponsor
- Archemix Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432770
- Sponsor's protocol ID
- 1779-06-001
- Status last verified
- Apr 2007
- First submitted
- 6 Feb 2007
- Last updated
- 20 Apr 2007
- Results posted
- No
Publications
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.
PubMed 30957581Gilbert 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.
PubMed 18025536
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00432770
- Acronym / sponsor ID
- 1779-06-001
- Conditions
- Thrombosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants
- Lead sponsor
- Archemix Corp.Industry (pharma, biotech, devices)
- Study start
- Dec 2006
- Study completion
- Mar 2007 (actual)
- First posted
- 8 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 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
Key exclusion criteria (14 listed)
- 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
- PT INR > 1.4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARC1779 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2007.
- Derived from this study: PubMed 30957581Park 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.
- Derived from this study: PubMed 18025536Gilbert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ARC1779 in people with Thrombosis, run by Archemix Corp. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00432770, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2007.