Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000681651
Ethics application status
Approved
Date submitted
21/06/2014
Date registered
27/06/2014
Date last updated
25/06/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety, Pharmacokinetics and Pharmacodynamics of ALD403
Scientific title
A Placebo-Controlled Trial to Determine the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of ALD403, a Humanized Anti-(Calcitonin Gene-Related Peptide) Monoclonal Antibody in Healthy Volunteers
Secondary ID [1] 284825 0
none
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migraine 292210 0
Condition category
Condition code
Neurological 292544 292544 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group A: ALD403 C1 process-derived 100 mg administered subcutaneously (SC) in the anterior abdominal wall on Days 1, 29, 57
Group B: ALD403 C2 process-derived 100 mg administered subcutaneously (SC) in the anterior abdominal wall on Days 1, 29, 57
Doses will be administered by study personnel at site visits.
Intervention code [1] 289617 0
Treatment: Drugs
Comparator / control treatment
Group C: Placebo for injection administered SC in the anterior abdominal wall Days 1, 29, 57
Group D: Placebo saline administered SC in the anterior abdominal wall Days 1, 29, 57
Control group
Placebo

Outcomes
Primary outcome [1] 292416 0
Vital Signs, Clinical Laboratory tests (hematology, chemistry) to assess safety of ALD403
Timepoint [1] 292416 0
Baseline, Days 1, 7, 15, 29, 35, 42, 57, 63, 70, 84, 140, 196
Primary outcome [2] 292417 0
ECG to assess safety of ALD403
Timepoint [2] 292417 0
Baseline, Days 1, 29, 57, 84, 140, 196
Primary outcome [3] 292418 0
Incidence of adverse events such as dizziness, rash and/or pain at injection site, headache; assessed by Principal Investigator.
Timepoint [3] 292418 0
Baseline throughout study to Day 196
Secondary outcome [1] 308899 0
Pharmacokinetics of ALD403
Timepoint [1] 308899 0
The concentrations of free ALD403 will be measured in plasma from all subjects in Groups A and B using a validated assay method after Dose 1, Dose 2, and Dose 3 and Day 70, Day 84, Day 140, and Day 196
Secondary outcome [2] 308900 0
Pharmacodynamics of ALD403 will be assessed by changes in forearm skin blood flow induced by topical capsaicin application and measured by a PeriCam blood perfusion imager.
Timepoint [2] 308900 0
Baseline, Days 1, 29, 42, 57, 70, 84, 140, 196.

Eligibility
Key inclusion criteria
Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception
Willing, committed, and able to comply with scheduled clinic visits and complete all trial-related procedures
Normal renal function as calculated by the Cockcroft-Gault equation at screening
Body Mass Index (BMI) between 18.0 and 30.0 kg/m2, and a total body weight of 50 to 100 kg inclusive
No history or presence of any other medical illness Ex-smoker (>6 months from quitting) or non-smoker
Agree not to post any personal medical data related to the trial or information related to the trial on any website or social media site (e.g., Facebook, Twitter) until the trial has been completed
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of febrile illness within 5 days prior to dosing
Clinically significant laboratory findings
Any ongoing co-morbidity or dermatological condition The presence of tattoos on the forearm, chest, or abdominal region Any medical condition that could put the patient at increased risk with exposure to an anti-CGRP antibody such as pre-existing cardiovascular (hypertension, ischemic heart disease), cerebrovascular disease, diabetes, or Raynaud’s disease
Onset of a new exercise routine or major change to a previous exercise routine within 2 weeks prior to screening visit. Subjects must be willing to refrain from unusually strenuous exercise for the duration of the trial
Hospitalization for any reason within 30 days of the screening visit
History of or positive human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), and/or Hepatitis C antibody (HCV) at screening
History of malignancy other than adequately treated carcinoma in-situ of the cervix, or adequately treated, non-metastatic squamous or basal cell carcinoma of the skin within five years prior to screening
History of past or current habitual drug abuse, including alcohol abuse History of rubber/latex allergy, or allergy to medical adhesives
History of capsaicin allergy
Known sensitivity to any of the components of the Investigational Product formulation
Receipt of any experimental, unregistered therapy (within or outside a clinical trial) within 30 days or 5 plasma half-lives (whichever is longer) before dosing
Receipt of monoclonal antibody treatment within 6 months of screening (within or outside a clinical trial)

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2014
Actual
2/07/2014
Date of last participant enrolment
Anticipated
Actual
18/08/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 289440 0
Commercial sector/Industry
Name [1] 289440 0
Alder Biopharmaceuticals
Country [1] 289440 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Alder Biopharmaceuticals
Address
11804 North Creek Parkway South
Bothell WA USA 98011
Country
United States of America
Secondary sponsor category [1] 288130 0
None
Name [1] 288130 0
Address [1] 288130 0
Country [1] 288130 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291199 0
The Alfred Hospital Ethics Committee
Ethics committee address [1] 291199 0
The Alfred Hospital
55 Commercial Road
Melbourne Victoria 3004
Ethics committee country [1] 291199 0
Australia
Date submitted for ethics approval [1] 291199 0
Approval date [1] 291199 0
01/08/2013
Ethics approval number [1] 291199 0
294/13

Summary
Brief summary
Purpose:
To determine the safety of multiple subcutaneous (SC) injections ALD403 compared to placebo in healthy female and male subjects.
To determine the pharmacokinetics, pharmacodynamics, and immunogenicity of ALD403 compared to placebo in healthy female and male subjects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49194 0
Dr Jason Lickliter
Address 49194 0
Nucleus Network Limited
Level 5 Burnet Institute, AMREP Precinct
89 Commercial Rd
Melbourne, VIC 3004
Country 49194 0
Australia
Phone 49194 0
+61 (0)3 9076 8906
Fax 49194 0
+61 (0)3 9076 8911
Email 49194 0
[email protected]
Contact person for public queries
Name 49195 0
Ms Sarah Wilson
Address 49195 0
Nucleus Network Limited
Level 5 Burnet Institute, AMREP Precinct
89 Commercial Rd
Melbourne, VIC 3004
Country 49195 0
Australia
Phone 49195 0
+61 (0)3 9076 8909
Fax 49195 0
Email 49195 0
[email protected]
Contact person for scientific queries
Name 49196 0
Ms Sarah Wilson
Address 49196 0
Nucleus Network Limited
Level 5 Burnet Institute, AMREP Precinct
89 Commercial Rd
Melbourne, VIC 3004
Country 49196 0
Australia
Phone 49196 0
+61 (0)3 9076 8909
Fax 49196 0
Email 49196 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.