A 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 to Healthy Volunteers - Full Text View

Sponsor:	Isis Pharmaceuticals
Collaborator:	Anapharm
Information provided by:	Isis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00734240

Purpose

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.

Condition	Intervention	Phase
Inflammatory Diseases	Drug: ISIS 353512	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Pharmacokinetics/Dynamics Study
Official Title:	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 to Healthy Volunteers

Further study details as provided by Isis Pharmaceuticals:

Primary Outcome Measures:

To evaluate the safety and tolerability of single and multiple doses of ISIS 353512 administered intravenously. [ Time Frame: 14 Days post treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the pharmacokinetic profile of single and multiple doses of ISIS 353512 administered intravenously. [ Time Frame: 14 Days post treatment ] [ Designated as safety issue: No ]
To evaluate the pharmacodynamics of ISIS 353512 administered intravenously. [ Time Frame: 14 Days post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	58
Study Start Date:	July 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental single-dose cohort (n=4, randomized 3 active : 1 placebo)receiving 50 mg ISIS 353512 or placebo.	Drug: ISIS 353512 50 mg via 2 hour IV infusion, Single Dose
B: Experimental single-dose cohort (n=4, randomized 3 active : 1 placebo)receiving 100 mg ISIS 353512 or placebo.	Drug: ISIS 353512 100 mg via 2 hour IV infusion, Single Dose
C: Experimental single-dose cohort (n=4, randomized 3 active : 1 placebo)receiving 200 mg ISIS 353512 or placebo.	Drug: ISIS 353512 200 mg via 2 hour IV infusion, Single Dose
D: Experimental single-dose cohort (n=4, randomized 3 active : 1 placebo)receiving 400 mg ISIS 353512 or placebo.	Drug: ISIS 353512 400 mg via 2 hour IV infusion, Single Dose
E: Experimental single-dose cohort (n=4, randomized 3 active : 1 placebo)receiving 600 mg ISIS 353512 or placebo.	Drug: ISIS 353512 600 mg via 2 hour IV infusion, Single Dose
AA: Experimental Multiple-dose cohort (n=4, randomized 3 active : 1 placebo) receiving six 50 mg doses of ISIS 353512 or placebo.	Drug: ISIS 353512 50 mg via 2 hour IV infusion, 6 doses Dose over 22 days.
BB: Experimental Multiple-dose cohort (n=4, randomized 3 active : 1 placebo) receiving six 100 mg doses of ISIS 353512 or placebo.	Drug: ISIS 353512 100 mg via 2 hour IV infusion, 6 doses Dose over 22 days.
CC: Experimental Multiple-dose cohort (n=10, randomized 8 active : 2 placebo) receiving six 200 mg doses of ISIS 353512 or placebo.	Drug: ISIS 353512 200 mg via 2 hour IV infusion, 6 doses Dose over 22 days.
DD: Experimental Multiple-dose cohort (n=10, randomized 8 active : 2 placebo) receiving six 400 mg doses of ISIS 353512 or placebo.	Drug: ISIS 353512 400 mg via 2 hour IV infusion, 6 doses Dose over 22 days.
EE: Experimental Multiple-dose cohort (n=10, randomized 8 active : 2 placebo) receiving six 600 mg doses of ISIS 353512 or placebo.	Drug: ISIS 353512 600 mg via 2 hour IV infusion, 6 doses Dose over 22 days.

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, 2)to evaluate the pharmacokinetic profile of single and multiple doses of ISIS 353512 administered intravenously, and 3) to evaluate the pharmacodynamics of ISIS 353512 in lowering constitutive levels of c-reactive proteins in healthy volunteers.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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 ≥ 2.0 mg/L and ≤ 5.0 mg/L (for 2 measurements ≥ 2 weeks apart)(Multiple Dose Subjects only)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734240

Contacts

Contact: Isabelle Boisclair

(514) 485-7500

Locations

Canada, Quebec
Anapharm	Recruiting
Montreal, Quebec, Canada, H3X 2H9
Contact: Boisclair iboisclair@anapharm.com
Principal Investigator: Richard Larouche, M.D.

Sponsors and Collaborators

Isis Pharmaceuticals

Anapharm

Investigators

Principal Investigator:

Richard Larouche, M.D.

Anapharm

More Information

No publications provided

Responsible Party:	ISIS Pharmaceuticals ( ISIS Pharmaceuticals )
Study ID Numbers:	ISIS 353512 CS1
Study First Received:	August 12, 2008
Last Updated:	August 12, 2008
ClinicalTrials.gov Identifier:	NCT00734240 History of Changes
Health Authority:	Canada: Health Canada

ClinicalTrials.gov processed this record on November 20, 2009