Safety and Tolerability of Single and Multiple Doses of ISIS 353512 in Healthy Volunteers
July 28, 2010 updated by: Ionis Pharmaceuticals, Inc.
Double Blind, Placebo-Controlled, Dose-Escalation, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ISIS 353512 Administered Intravenously and Subcutaneously to Healthy Volunteers
The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of ISIS 353512, to evaluate the blood concentration and rate elimination of ISIS 353512 from the blood, and to evaluate the effectiveness of ISIS 353512 in lowering a protein in the blood associated with inflammation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This will be a Phase 1, double blind, placebo-controlled, dose-escalation study conducted at a single center to 1)evaluate the safety and tolerability of single and multiple doses of ISIS 353512 administered intravenously and subcutaneously, 2)evaluate the pharmacokinetic profile of single and multiple doses of ISIS 353512 administered intravenously and subcutaneously, and 3)evaluate the pharmacodynamics of ISIS 353512 in lowering constitutive levels of c-reactive proteins in healthy volunteers.
Study Type
Interventional
Enrollment (Actual)
103
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3X 2H9
- Anapharm
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18 to 55 years
- Male or female although females must be post-menopausal or surgically sterile
- In good health
- BMI < 32 kg/m2
- Give written informed consent to participate in the study
- hsCRP at Screening ≥ 0.50 mg/L and ≤ 5.0 mg/L (for 2 measurements ≥ 2 weeks apart; with difference between measurements ≤ 2.5 mg/L)(Multiple Dose Subjects only, not including dose-titration cohorts)
Exclusion Criteria:
- Pregnant women, nursing mothers or women of childbearing potential
- Clinically significant abnormalities in medical history or physical examination
- Clinically significant ECG abnormalities or vital sign abnormalities (systolic blood pressure < 90 mm Hg or > 140 mm Hg, diastolic blood pressure < 50 mm Hg or > 90 mm Hg or heat rate < 50 or > 100 bpm) at Screening
- Clinically significant abnormalities on laboratory examination, other than hsCRP
- Clinically significant abnormalities in coagulation parameters
- Positive test for HIV, TB (PPD test) or hepatitis B or C at Screening
- History of latent or active tuberculosis or exposure to endemic areas within 8 weeks prior to PPD test at Screening
- History of positive PPD test or positive PPD test result (≥ 5 mm) indicating possible tuberculosis infection
- Fasting triglycerides > 400 mg/dL at Screening
- Malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for > 1 year)
- Evidence of ongoing chronic inflammatory condition or infection
- Any other concurrent condition which, in the opinion of the Investigator, would preclude participation in this study or interfere with compliance
- Regular use of alcohol within 6 months prior to Screening (> 14 units of alcohol per week; 1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol)
- Use of soft drugs (such as marijuana) within 3 months prior to Screening or hard drugs (such as cocaine, phencyclidine [PCP] and crack) within 1 year prior to Screening, or positive urine drug screen at Screening
- Smoking > 10 cigarettes per day
- Use of an investigational drug or participation in an investigational study involving a small molecule with 30 days prior to dosing or participation in an investigational study involving biologic compounds within 90 days prior to dosing
- Regularly taking OTC medications and/or vitamin supplements that may alter CRP, e.g., NSAIDs, aspirin, vitamin E, fish oil, within 14 days prior to Screening
- Receiving prescription medications, including hormone replacement therapy, statins, TNF-α inhibitors, or other anti-inflammatory or immunosuppressive drugs within 30 days prior to Screening
- Immunization with a live attenuated vaccine one month prior to dosing or planned vaccination during the course of the study
- Blood donation of 50 to 499 mL within 30 days of Screening or of > 499 mL within 60 days of Screening
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A
single-dose cohort (n=4, randomized 3 active : 1 placebo) receiving ISIS 355312 or placebo
|
50 mg via 2 hour IV infusion, single dose
50 mg via 2 hour IV infusion, 6 doses over 22 days
50 mg via SC injection, single dose
50 mg via SC injection, 6 doses over 22 days
2 hour IV infusion, 50 mg on day 3, 100 mg on day 5, and 200 mg on day 8
100 mg via 2 hour IV infusion, single dose
200 mg via 2 hour IV infusion, single dose
100 mg via SC injection, single dose
200 mg via SC injection, single-dose
100 mg via 2 hour IV infusion, 6 doses over 22 days
200 mg via 2 hour IV infusion, 6 doses over 22 days
100 mg via SC injection, 6 doses over 22 days
200 mg via SC injection, 6 doses over 22 days
100 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or oral placebo
200 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or steroid
2 hour IV infusion, 50 mg on day 1, 100 mg on day 3, 100 mg on day 5 and 200mg on day 8
|
|
Experimental: B
single-dose cohort (n=4, randomized 3 active : 1 placebo) receiving ISIS 353512 or placebo
|
50 mg via 2 hour IV infusion, single dose
50 mg via 2 hour IV infusion, 6 doses over 22 days
50 mg via SC injection, single dose
50 mg via SC injection, 6 doses over 22 days
2 hour IV infusion, 50 mg on day 3, 100 mg on day 5, and 200 mg on day 8
100 mg via 2 hour IV infusion, single dose
200 mg via 2 hour IV infusion, single dose
100 mg via SC injection, single dose
200 mg via SC injection, single-dose
100 mg via 2 hour IV infusion, 6 doses over 22 days
200 mg via 2 hour IV infusion, 6 doses over 22 days
100 mg via SC injection, 6 doses over 22 days
200 mg via SC injection, 6 doses over 22 days
100 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or oral placebo
200 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or steroid
2 hour IV infusion, 50 mg on day 1, 100 mg on day 3, 100 mg on day 5 and 200mg on day 8
|
|
Experimental: C
single-dose cohort (n=4, randomized 3 active : 1 placebo) receiving ISIS 353512 or placebo
|
50 mg via 2 hour IV infusion, single dose
50 mg via 2 hour IV infusion, 6 doses over 22 days
50 mg via SC injection, single dose
50 mg via SC injection, 6 doses over 22 days
2 hour IV infusion, 50 mg on day 3, 100 mg on day 5, and 200 mg on day 8
100 mg via 2 hour IV infusion, single dose
200 mg via 2 hour IV infusion, single dose
100 mg via SC injection, single dose
200 mg via SC injection, single-dose
100 mg via 2 hour IV infusion, 6 doses over 22 days
200 mg via 2 hour IV infusion, 6 doses over 22 days
100 mg via SC injection, 6 doses over 22 days
200 mg via SC injection, 6 doses over 22 days
100 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or oral placebo
200 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or steroid
2 hour IV infusion, 50 mg on day 1, 100 mg on day 3, 100 mg on day 5 and 200mg on day 8
|
|
Experimental: AA
multiple-dose cohort (n=4, randomized 3 active : 1 placebo) receiving 353512 or placebo
|
50 mg via 2 hour IV infusion, single dose
50 mg via 2 hour IV infusion, 6 doses over 22 days
50 mg via SC injection, single dose
50 mg via SC injection, 6 doses over 22 days
2 hour IV infusion, 50 mg on day 3, 100 mg on day 5, and 200 mg on day 8
100 mg via 2 hour IV infusion, single dose
200 mg via 2 hour IV infusion, single dose
100 mg via SC injection, single dose
200 mg via SC injection, single-dose
100 mg via 2 hour IV infusion, 6 doses over 22 days
200 mg via 2 hour IV infusion, 6 doses over 22 days
100 mg via SC injection, 6 doses over 22 days
200 mg via SC injection, 6 doses over 22 days
100 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or oral placebo
200 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or steroid
2 hour IV infusion, 50 mg on day 1, 100 mg on day 3, 100 mg on day 5 and 200mg on day 8
|
|
Experimental: BB
multiple-dose cohort (n=4, randomized 3 active : 1 placebo) receiving ISIS 353512 or placebo
|
50 mg via 2 hour IV infusion, single dose
50 mg via 2 hour IV infusion, 6 doses over 22 days
50 mg via SC injection, single dose
50 mg via SC injection, 6 doses over 22 days
2 hour IV infusion, 50 mg on day 3, 100 mg on day 5, and 200 mg on day 8
100 mg via 2 hour IV infusion, single dose
200 mg via 2 hour IV infusion, single dose
100 mg via SC injection, single dose
200 mg via SC injection, single-dose
100 mg via 2 hour IV infusion, 6 doses over 22 days
200 mg via 2 hour IV infusion, 6 doses over 22 days
100 mg via SC injection, 6 doses over 22 days
200 mg via SC injection, 6 doses over 22 days
100 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or oral placebo
200 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or steroid
2 hour IV infusion, 50 mg on day 1, 100 mg on day 3, 100 mg on day 5 and 200mg on day 8
|
|
Experimental: CC
multiple-dose cohort (n=4, randomized 3 active : 1 placebo) receiving ISIS 353512 or placebo
|
50 mg via 2 hour IV infusion, single dose
50 mg via 2 hour IV infusion, 6 doses over 22 days
50 mg via SC injection, single dose
50 mg via SC injection, 6 doses over 22 days
2 hour IV infusion, 50 mg on day 3, 100 mg on day 5, and 200 mg on day 8
100 mg via 2 hour IV infusion, single dose
200 mg via 2 hour IV infusion, single dose
100 mg via SC injection, single dose
200 mg via SC injection, single-dose
100 mg via 2 hour IV infusion, 6 doses over 22 days
200 mg via 2 hour IV infusion, 6 doses over 22 days
100 mg via SC injection, 6 doses over 22 days
200 mg via SC injection, 6 doses over 22 days
100 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or oral placebo
200 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or steroid
2 hour IV infusion, 50 mg on day 1, 100 mg on day 3, 100 mg on day 5 and 200mg on day 8
|
|
Experimental: G
single-dose cohort (n=4, randomized 3 active : 1 placebo) receiving ISIS 353512 or placebo
|
50 mg via 2 hour IV infusion, single dose
50 mg via 2 hour IV infusion, 6 doses over 22 days
50 mg via SC injection, single dose
50 mg via SC injection, 6 doses over 22 days
2 hour IV infusion, 50 mg on day 3, 100 mg on day 5, and 200 mg on day 8
100 mg via 2 hour IV infusion, single dose
200 mg via 2 hour IV infusion, single dose
100 mg via SC injection, single dose
200 mg via SC injection, single-dose
100 mg via 2 hour IV infusion, 6 doses over 22 days
200 mg via 2 hour IV infusion, 6 doses over 22 days
100 mg via SC injection, 6 doses over 22 days
200 mg via SC injection, 6 doses over 22 days
100 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or oral placebo
200 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or steroid
2 hour IV infusion, 50 mg on day 1, 100 mg on day 3, 100 mg on day 5 and 200mg on day 8
|
|
Experimental: H
single-dose cohort (n=4, randomized 3 active : 1 placebo) receiving ISIS 353512 or placebo
|
50 mg via 2 hour IV infusion, single dose
50 mg via 2 hour IV infusion, 6 doses over 22 days
50 mg via SC injection, single dose
50 mg via SC injection, 6 doses over 22 days
2 hour IV infusion, 50 mg on day 3, 100 mg on day 5, and 200 mg on day 8
100 mg via 2 hour IV infusion, single dose
200 mg via 2 hour IV infusion, single dose
100 mg via SC injection, single dose
200 mg via SC injection, single-dose
100 mg via 2 hour IV infusion, 6 doses over 22 days
200 mg via 2 hour IV infusion, 6 doses over 22 days
100 mg via SC injection, 6 doses over 22 days
200 mg via SC injection, 6 doses over 22 days
100 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or oral placebo
200 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or steroid
2 hour IV infusion, 50 mg on day 1, 100 mg on day 3, 100 mg on day 5 and 200mg on day 8
|
|
Experimental: I
single-dose cohort (n=4, randomized 3 active : 1 placebo) receiving ISIS 353512 or placebo
|
50 mg via 2 hour IV infusion, single dose
50 mg via 2 hour IV infusion, 6 doses over 22 days
50 mg via SC injection, single dose
50 mg via SC injection, 6 doses over 22 days
2 hour IV infusion, 50 mg on day 3, 100 mg on day 5, and 200 mg on day 8
100 mg via 2 hour IV infusion, single dose
200 mg via 2 hour IV infusion, single dose
100 mg via SC injection, single dose
200 mg via SC injection, single-dose
100 mg via 2 hour IV infusion, 6 doses over 22 days
200 mg via 2 hour IV infusion, 6 doses over 22 days
100 mg via SC injection, 6 doses over 22 days
200 mg via SC injection, 6 doses over 22 days
100 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or oral placebo
200 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or steroid
2 hour IV infusion, 50 mg on day 1, 100 mg on day 3, 100 mg on day 5 and 200mg on day 8
|
|
Experimental: GG
multiple-dose cohort (n=4, randomized 3 active : 1 placebo) receiving ISIS 353512 or placebo
|
50 mg via 2 hour IV infusion, single dose
50 mg via 2 hour IV infusion, 6 doses over 22 days
50 mg via SC injection, single dose
50 mg via SC injection, 6 doses over 22 days
2 hour IV infusion, 50 mg on day 3, 100 mg on day 5, and 200 mg on day 8
100 mg via 2 hour IV infusion, single dose
200 mg via 2 hour IV infusion, single dose
100 mg via SC injection, single dose
200 mg via SC injection, single-dose
100 mg via 2 hour IV infusion, 6 doses over 22 days
200 mg via 2 hour IV infusion, 6 doses over 22 days
100 mg via SC injection, 6 doses over 22 days
200 mg via SC injection, 6 doses over 22 days
100 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or oral placebo
200 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or steroid
2 hour IV infusion, 50 mg on day 1, 100 mg on day 3, 100 mg on day 5 and 200mg on day 8
|
|
Experimental: HH
multiple-dose cohort (n=4, randomized 3 active : 1 placebo) receiving ISIS 353512 or placebo
|
50 mg via 2 hour IV infusion, single dose
50 mg via 2 hour IV infusion, 6 doses over 22 days
50 mg via SC injection, single dose
50 mg via SC injection, 6 doses over 22 days
2 hour IV infusion, 50 mg on day 3, 100 mg on day 5, and 200 mg on day 8
100 mg via 2 hour IV infusion, single dose
200 mg via 2 hour IV infusion, single dose
100 mg via SC injection, single dose
200 mg via SC injection, single-dose
100 mg via 2 hour IV infusion, 6 doses over 22 days
200 mg via 2 hour IV infusion, 6 doses over 22 days
100 mg via SC injection, 6 doses over 22 days
200 mg via SC injection, 6 doses over 22 days
100 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or oral placebo
200 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or steroid
2 hour IV infusion, 50 mg on day 1, 100 mg on day 3, 100 mg on day 5 and 200mg on day 8
|
|
Experimental: II
multiple-dose cohort (n=4, randomized 3 active : 1 placebo) receiving ISIS 353512 or placebo
|
50 mg via 2 hour IV infusion, single dose
50 mg via 2 hour IV infusion, 6 doses over 22 days
50 mg via SC injection, single dose
50 mg via SC injection, 6 doses over 22 days
2 hour IV infusion, 50 mg on day 3, 100 mg on day 5, and 200 mg on day 8
100 mg via 2 hour IV infusion, single dose
200 mg via 2 hour IV infusion, single dose
100 mg via SC injection, single dose
200 mg via SC injection, single-dose
100 mg via 2 hour IV infusion, 6 doses over 22 days
200 mg via 2 hour IV infusion, 6 doses over 22 days
100 mg via SC injection, 6 doses over 22 days
200 mg via SC injection, 6 doses over 22 days
100 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or oral placebo
200 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or steroid
2 hour IV infusion, 50 mg on day 1, 100 mg on day 3, 100 mg on day 5 and 200mg on day 8
|
|
Experimental: F (100 mg)
single-dose cohort (n=4, randomized 3 active: 1 placebo) receiving ISIS 353512 or placebo
|
50 mg via 2 hour IV infusion, single dose
50 mg via 2 hour IV infusion, 6 doses over 22 days
50 mg via SC injection, single dose
50 mg via SC injection, 6 doses over 22 days
2 hour IV infusion, 50 mg on day 3, 100 mg on day 5, and 200 mg on day 8
100 mg via 2 hour IV infusion, single dose
200 mg via 2 hour IV infusion, single dose
100 mg via SC injection, single dose
200 mg via SC injection, single-dose
100 mg via 2 hour IV infusion, 6 doses over 22 days
200 mg via 2 hour IV infusion, 6 doses over 22 days
100 mg via SC injection, 6 doses over 22 days
200 mg via SC injection, 6 doses over 22 days
100 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or oral placebo
200 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or steroid
2 hour IV infusion, 50 mg on day 1, 100 mg on day 3, 100 mg on day 5 and 200mg on day 8
|
|
Experimental: Dose-Titration 1
multiple-dose cohort (n=4, randomized 3 active: 1 placebo) receiving ISIS 353512 or placebo
|
50 mg via 2 hour IV infusion, single dose
50 mg via 2 hour IV infusion, 6 doses over 22 days
50 mg via SC injection, single dose
50 mg via SC injection, 6 doses over 22 days
2 hour IV infusion, 50 mg on day 3, 100 mg on day 5, and 200 mg on day 8
100 mg via 2 hour IV infusion, single dose
200 mg via 2 hour IV infusion, single dose
100 mg via SC injection, single dose
200 mg via SC injection, single-dose
100 mg via 2 hour IV infusion, 6 doses over 22 days
200 mg via 2 hour IV infusion, 6 doses over 22 days
100 mg via SC injection, 6 doses over 22 days
200 mg via SC injection, 6 doses over 22 days
100 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or oral placebo
200 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or steroid
2 hour IV infusion, 50 mg on day 1, 100 mg on day 3, 100 mg on day 5 and 200mg on day 8
|
|
Experimental: F (200 mg)
single-dose cohort (n=4, randomized 3 active: 1 placebo) receiving ISIS 353512 or placebo
|
50 mg via 2 hour IV infusion, single dose
50 mg via 2 hour IV infusion, 6 doses over 22 days
50 mg via SC injection, single dose
50 mg via SC injection, 6 doses over 22 days
2 hour IV infusion, 50 mg on day 3, 100 mg on day 5, and 200 mg on day 8
100 mg via 2 hour IV infusion, single dose
200 mg via 2 hour IV infusion, single dose
100 mg via SC injection, single dose
200 mg via SC injection, single-dose
100 mg via 2 hour IV infusion, 6 doses over 22 days
200 mg via 2 hour IV infusion, 6 doses over 22 days
100 mg via SC injection, 6 doses over 22 days
200 mg via SC injection, 6 doses over 22 days
100 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or oral placebo
200 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or steroid
2 hour IV infusion, 50 mg on day 1, 100 mg on day 3, 100 mg on day 5 and 200mg on day 8
|
|
Experimental: Dose-Titration 7
multiple-dose cohort (n=4, randomized 3 active: 1 placebo) receiving ISIS 353512 or placebo
|
50 mg via 2 hour IV infusion, single dose
50 mg via 2 hour IV infusion, 6 doses over 22 days
50 mg via SC injection, single dose
50 mg via SC injection, 6 doses over 22 days
2 hour IV infusion, 50 mg on day 3, 100 mg on day 5, and 200 mg on day 8
100 mg via 2 hour IV infusion, single dose
200 mg via 2 hour IV infusion, single dose
100 mg via SC injection, single dose
200 mg via SC injection, single-dose
100 mg via 2 hour IV infusion, 6 doses over 22 days
200 mg via 2 hour IV infusion, 6 doses over 22 days
100 mg via SC injection, 6 doses over 22 days
200 mg via SC injection, 6 doses over 22 days
100 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or oral placebo
200 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or steroid
2 hour IV infusion, 50 mg on day 1, 100 mg on day 3, 100 mg on day 5 and 200mg on day 8
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To evaluate the safety and tolerability of single and multiple doses of ISIS 353512 administered intravenously and subcutaneously.
Time Frame: 14 Days post treatment of each cohort
|
14 Days post treatment of each cohort
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To evaluate the pharmacokinetic profile of single and multiple doses of ISIS 353512 administered intravenously and subcutaneously.
Time Frame: 14 Days post treatment of each cohort
|
14 Days post treatment of each cohort
|
|
To evaluate the pharmacodynamics of ISIS 353512 administered intravenously and subcutaneously.
Time Frame: 14 Days post treatment of each cohort
|
14 Days post treatment of each cohort
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
August 12, 2008
First Submitted That Met QC Criteria
August 12, 2008
First Posted (Estimate)
August 14, 2008
Study Record Updates
Last Update Posted (Estimate)
July 29, 2010
Last Update Submitted That Met QC Criteria
July 28, 2010
Last Verified
July 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- ISIS 353512 CS1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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