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Trial registered on ANZCTR


Registration number
ACTRN12615000531516
Ethics application status
Approved
Date submitted
6/05/2015
Date registered
27/05/2015
Date last updated
6/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of ALD403
Scientific title
A Multiple Dose, 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] 286635 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migraine 294958 0
Condition category
Condition code
Neurological 295220 295220 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group A and Group B: ALD403 100 mg injected on Days 1 and 84
Group C: ALD403 100 mg infused on Days 1 and 84
Group D: ALD403 300 mg injected on Days 1 and 84

Doses will be administered by study personnel at site visits.
Intervention code [1] 291777 0
Treatment: Drugs
Comparator / control treatment
Placebo Saline injected and infused on Days 1 and 84

Control group
Placebo

Outcomes
Primary outcome [1] 294973 0
Incidence of adverse events assessed by Principal Investigator at site visits using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v4.03
Timepoint [1] 294973 0
Baseline throughout study to Day 168
Primary outcome [2] 294974 0
Vital Signs, Clinical Laboratory tests (hematology, chemistry) to assess safety of ALD403
Timepoint [2] 294974 0
Baseline, Days 1,15, 28, 56, 84, 98, 112, 140, and 168
Primary outcome [3] 295032 0
ECG to assess safety of ALD403
Timepoint [3] 295032 0
Baseline, Days 1,15, 28, 56, 84, 98, 112, 140, and 168
Secondary outcome [1] 314493 0
Pharmacokinetics of ALD403 will be assessed by measuring the concentrations of free ALD403 in plasma from all participants treated with ALD403 using a validated assay method
Timepoint [1] 314493 0
Days 1, 2, 3, 4, 5, 6, 7, 15, 28, 56, 84, 90, 112, 140, and 168.
Secondary outcome [2] 314494 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] 314494 0
Baseline, Days 2, 5, 7, 15, 28, 56, 84, 85, 88, 90, 98, 112, 140, and 168

Eligibility
Key inclusion criteria
1. Healthy females and males 18 to 65 years of age inclusive

2. Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (oral or injectable [depot] estrogen, and/or progestogen, or oral contraceptive, intrauterine contraceptive device, or double barrier method [e.g., condom and diaphragm) or exercise abstinence during and for at least 6 months after the last dose of study drug. Non-childbearing potential is defined as post-menopausal for at least 1 year or surgical sterilization or hysterectomy at least 3 months before trial start

3. Willing, committed, and able to comply with scheduled clinic visits and complete all trial-related procedures

4. Normal renal function as calculated by the Cockcroft-Gault equation at screening

5. No history or presence of any other medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, or any clinically significant laboratory abnormality, that in the judgment of the investigator, indicates a medical problem that would preclude trial participation
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Women who are pregnant, planning to become pregnant, or breastfeeding

2. Clinically significant laboratory findings showing evidence of organ dysfunction, any clinically significant deviation from the normal range, or clinically significant physical exam abnormalities at screening, as evaluated by the Investigator

3. Any ongoing co-morbidity or dermatological condition (e.g., psoriasis, eczema, severe acne requiring treatment) that in the opinion of the Investigator will interfere with the evaluation and participation in the trial

4. The presence of tattoos on the forearm, chest, or abdominal region that could interfere with the evaluation of safety and study endpoints in the trial

5. 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

6. Use of any concomitant medications within 14 days of dosing, unless authorized by the Sponsor and/or PI

7. 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

8. 12-lead ECG demonstrating QTcF > 450 msec at Screening. If QTcF exceeds 450 msec, the ECG should be repeated two more times and the average of the three QTcF values should be used to determine the subject's eligibility

9. Hospitalization for any reason within 30 days of the screening visit

10. History of or positive human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), and/or Hepatitis C antibody (HCV) at screening

11. 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

12. History of past or current habitual drug abuse, including alcohol abuse or positive urine drugs of abuse result at screening

13. History of capsaicin allergy

14. Less than or equal to 50% Increase in perfusion (skin blood flow) following topical capsaicin challenge relative to vehicle challenge at screening

15. Known sensitivity to any of the components of the Investigational Product formulation

16. 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

17. Receipt of monoclonal antibody treatment within 6 months of screening (within or outside a clinical trial) or previous treatment with ALD403

18. Planned or current participation in any other clinical trial during this 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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 291210 0
Commercial sector/Industry
Name [1] 291210 0
Alder BioPharmaceuticals, Inc.
Address [1] 291210 0
11804 North Creek Parkway South, Bothell WA USA 98011
Country [1] 291210 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Alder BioPharmaceuticals, Inc.
Address
11804 North Creek Parkway South, Bothell WA USA 98011
Country
United States of America
Secondary sponsor category [1] 289889 0
None
Name [1] 289889 0
Address [1] 289889 0
Country [1] 289889 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292774 0
The Alfred Hospital Ethics Committee
Ethics committee address [1] 292774 0
The Alfred Hospital
55 Commercial Road
Melbourne Victoria 3004
Ethics committee country [1] 292774 0
Australia
Date submitted for ethics approval [1] 292774 0
Approval date [1] 292774 0
01/05/2015
Ethics approval number [1] 292774 0
148/15

Summary
Brief summary
To determine the safety and tolerability of ALD403 via injection and infusion in healthy participants.

To determine the pharmacokinetics, pharmacodynamics, and immunogenicity of ALD403 via injection and infusion in healthy participants.
Trial website
Trial related presentations / publications
We do not have any trial-related citations at this time.
Public notes

Contacts
Principal investigator
Name 56958 0
Dr Jason Lickliter
Address 56958 0
Nucleus Network Limited
Level 5 Burnet Institute, AMREP Precinct
89 Commercial Rd
Melbourne, VIC 3004
Country 56958 0
Australia
Phone 56958 0
+61 (0)3 9076 8906
Fax 56958 0
+61 (0)3 9076 8911
Email 56958 0
J.Lickliter@nucleusnetwork.com.au
Contact person for public queries
Name 56959 0
Ms Biljana Georgievska
Address 56959 0
Nucleus Network Limited
Level 5 Burnet Institute, AMREP Precinct
89 Commercial Rd
Melbourne, VIC 3004
Country 56959 0
Australia
Phone 56959 0
+ 61 3 9076 9017
Fax 56959 0
Email 56959 0
B.Georgievska@nucleusnetwork.com.au
Contact person for scientific queries
Name 56960 0
Ms Biljana Georgievska
Address 56960 0
Nucleus Network Limited
Level 5 Burnet Institute, AMREP Precinct
89 Commercial Rd
Melbourne, VIC 3004
Country 56960 0
Australia
Phone 56960 0
+ 61 3 9076 9017
Fax 56960 0
Email 56960 0
B.Georgievska@nucleusnetwork.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary