Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000123943
Ethics application status
Approved
Date submitted
2/02/2011
Date registered
3/02/2011
Date last updated
26/02/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized, placebo controlled, double blind, phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single escalating doses of SAN-300 when administered to healthy subjects and patients with rheumatoid arthritis
Scientific title
A phase 1 study of healthy subjects and patients with rheumatoid arthritis receiving single doses of SAN-300 or placebo to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SAN-300
Secondary ID [1] 253526 0
Santarus, Inc. Study C2011-0301
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Active Rheumatoid Arthritis 261085 0
Condition category
Condition code
Inflammatory and Immune System 259226 259226 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
SAN-300 is a humanized anti-VLA-1 MAb. Eight cohorts of healthy subjects, plus 1 cohort of patients with rheumatoid arthritis, will receive single doses ranging from 0.03 mg/kg to 2 mg/kg, intravenously infused over 4 hours. Additionally, 3 Cohorts of healthy subjects will receive a single dose of SAN-300 by subcutaneous injection (an injection just beneath the skin). (The dose of SAN-300 in each Cohort is listed below: Cohort A (healthy subjects): 0.03 mg/kg Cohort B (healthy subjects): 0.1 mg/kg Cohort C (healthy subjects): 0.3 mg/kg Cohort D (healthy subjects): 1.0 mg/kg Cohort E (healthy subjects): 0.6 mg/kg Cohort F (healthy subjects): 0.8 mg/kg Cohort G (healthy subjects): 1.0 mg/kg Cohort H (healthy subjects): 2.0 mg/kg Cohort I (Rheumatoid Arthritis patients) 2.0 mg/kg. The subcutaneous cohorts are; Cohort J (healthy subjects): 2 mg/kg Cohort K (healthy subjects): 4 mg/kg Cohort L (healthy subjects): 6 mg/kg
Intervention code [1] 257955 0
Treatment: Drugs
Comparator / control treatment
Placebo for IV infusion is normal saline.
Placebo for subcutaneous (SC) injection is a histidine solution (pH 6) with a small amount of riboflavin for coloring so that it matches the drug product.
Control group
Placebo

Outcomes
Primary outcome [1] 262059 0
The safety and tolerability after a single dose of SAN-300 through 1 month after dosing.

Safety and tolerability will be assessed by serum chemistry, hematology, urinalysis, physical exam, vital signs, and electrocardiogram.
Timepoint [1] 262059 0
Subjects will receive the dose of study drug and remain in the clinic for 24 hours. There are 5 follow up visits conducted over 1 month (Day 3, Day 8, Day 15, Day 22 and Day 29).
Secondary outcome [1] 273069 0
Characterization of the pharmacokinetics and pharmacodynamics after a single dose of SAN-300, through 1 month after dosing
Timepoint [1] 273069 0
Subjects will receive the dose of study drug and remain in the clinic for 24 hours. There are 5 follow up visits conducted over 1 month (Day 3, Day 8, Day 15, Day 22 and Day 29).

Eligibility
Key inclusion criteria
Healthy Subjects:

-Healthy Men and Women

-18 to 55 years of age

-Those who are of child-bearing potential must be willing to use adequate birth control measures during the study.

Participation in the study lasts approximately 1 month.

Rheumatoid Arthritis (RA) Patients:

-18 to 65 years of age

-Diagnosis of RA for greater than or equal to 6 months; swollen joint count greater than or equal to 5 and tender joint count greater than or equal to 5; on current background therapy.

-Those who are of child-bearing potential must be willing to use adequate birth control measures during the study.

Participation in the study lasts approximately 1 month.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Healthy Subjects and Patients with Rheumatoid Arthritis:

-History of malignancy, carcinoma, other major diseases or severe allergic reactions.

-History of clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major diseases.

-History of opportunistic infection or recurrent clinically significant infections.

-History of malaria or travel to a malaria endemic region within one year.

-History of positive blood test for hepatitis C, hepatitis B or HIV.

-History of tuberculosis or positive QuantiFERON-TB Gold test.

-History of drug or alcohol abuse.

-Any live immunization/vaccination within 4 weeks before study drug administration.

Women who are pregnant or breastfeeding will be excluded.

Rheumatoid Arthritis Patients:

-Functional Class IV as defined by ACR classification.

-History of significant systemic involvement secondary to RA.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
When it is determined that the subject is eligible for the study and meets all the inclusion and exclusion criteria, they will be assigned to be enrolled in a sequential manner into one of the dosing groups. Sealed opaque envelopes will be used to conceal the treatment assignment. Within each dosing group, subjects will be randomly assigned to receive either SAN-300 or placebo. Dosing groups A, B, C, D, E, F, G, H, J, K and L include the healthy subjects and dosing group I includes the patients with active rheumatoid arthritis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Within each dosing group, subjects will be randomly assigned to receive either SAN-300 or placebo using a randomisation table created by computer software. In Cohorts A, B, E, F, G, H, J, K and L four subjects will receive SAN-300 and 2 will receive placebo. In Cohorts C and I, 6 subjects will receive SAN-300 and 2 will receive placebo. In Cohort D, 3 subjects will recieve SAN-300 and 1 will receive placebo.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
74
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258417 0
Commercial sector/Industry
Name [1] 258417 0
Santarus, Inc.
Country [1] 258417 0
United States of America
Funding source category [2] 286806 0
Commercial sector/Industry
Name [2] 286806 0
Santarus, Inc.
Country [2] 286806 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Santarus, Inc.
Address
3611 Valley Centre Drive, Suite 400, San Diego, California 92130
Country
United States of America
Secondary sponsor category [1] 257568 0
None
Name [1] 257568 0
Address [1] 257568 0
Country [1] 257568 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260395 0
The Alfred Hospital Ethics Committee
Ethics committee address [1] 260395 0
55 Commercial Road 3004, Melbourne Victoria
Ethics committee country [1] 260395 0
Australia
Date submitted for ethics approval [1] 260395 0
17/01/2011
Approval date [1] 260395 0
Ethics approval number [1] 260395 0
Ethics committee name [2] 287019 0
Bellberry Human Research Ethics Committee
Ethics committee address [2] 287019 0
229 Greenhil Rd
Dulwich, SA 5065
Ethics committee country [2] 287019 0
Date submitted for ethics approval [2] 287019 0
04/01/2012
Approval date [2] 287019 0
18/01/2012
Ethics approval number [2] 287019 0
New ethics HREC. Please modify.
Ethics committee name [3] 288872 0
There is no new Ethics committee
Ethics committee address [3] 288872 0
Ethics committee country [3] 288872 0
Date submitted for ethics approval [3] 288872 0
Approval date [3] 288872 0
Ethics approval number [3] 288872 0
Ethics committee name [4] 288873 0
There is no new Ethics committee
Ethics committee address [4] 288873 0
Ethics committee country [4] 288873 0
Date submitted for ethics approval [4] 288873 0
Approval date [4] 288873 0
Ethics approval number [4] 288873 0

Summary
Brief summary
Study C2011-0301 is the first study in man for SAN-300. SAN-300 is being developed for the treatment of rheumatoid arthritis. SAN-300 will be administered intravenously in 9 cohorts and subcutaneously in 3 cohorts. Approximately 66 healthy volunteers and approximately 8 patients with active rheumatoid arthritis will be enrolled to receive a single dose of SAN-300 or Placebo. Participation in the study is approximately 1 month, including dosing and follow-up visits. Subjects will receive the dose of study drug and remain in the clinic for 24 hours. There are 5 follow up visits conducted over 1 month.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32159 0
Andrew Redfern
Address 32159 0
Linear Clinical Research, 1st Floor, B Block, Hospital Avenue, Nedlands WA 6009
Country 32159 0
Australia
Phone 32159 0
+ 61 89346 3660
Fax 32159 0
Email 32159 0
[email protected]
Contact person for public queries
Name 15406 0
Cameron Johnson
Address 15406 0
Linear Clinical Research
1st Floor, B Block, Hospital Avenue
Nedlands WA 6009
Country 15406 0
Australia
Phone 15406 0
+61 (0) 8 6382 5100
Fax 15406 0
+61 (0) 8 9381 4453
Email 15406 0
[email protected]
Contact person for scientific queries
Name 6334 0
Cameron Johnson
Address 6334 0
Linear Clinical Research
1st Floor, B Block, Hospital Avenue
Nedlands WA 6009
Country 6334 0
Australia
Phone 6334 0
+61 (0) 8 6382 5100
Fax 6334 0
+61 (0) 8 9381 4453
Email 6334 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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