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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02859701




Registration number
NCT02859701
Ethics application status
Date submitted
13/07/2016
Date registered
9/08/2016
Date last updated
26/09/2017

Titles & IDs
Public title
Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AK002 in Healthy Participants
Scientific title
A Phase 1, Double-Blind, Placebo-Controlled, Single Ascending and Multi Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AK002 in Healthy Participants
Secondary ID [1] 0 0
AK002-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AK002

Experimental: AK002 - AK002 will be administered as an intravenous (IV) infusion in 8 cohorts of single escalating doses and two cohorts with multiple doses

Placebo comparator: Placebo - Placebo administered as anl IV infusion


Treatment: Drugs: AK002
IV AK002
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability of AK002 as assessed by incidence, nature and severity of AEs and SAEs.
Timepoint [1] 0 0
Screening to day 112
Secondary outcome [1] 0 0
Evaluate pharmacokinetic parameter AUC for AK002.
Timepoint [1] 0 0
Baseline to Day 112
Secondary outcome [2] 0 0
Change from baseline of absolute peripheral blood counts of eosinophils.
Timepoint [2] 0 0
baseline to Day 112
Secondary outcome [3] 0 0
Change from baseline of absolute peripheral blood counts of basophils.
Timepoint [3] 0 0
baseline to Day 112
Secondary outcome [4] 0 0
Changes in serum tryptase levels
Timepoint [4] 0 0
baseline to Day 112
Secondary outcome [5] 0 0
Evaluate pharmacokinetic parameter CMAX for AK002.
Timepoint [5] 0 0
baseline to day 112
Secondary outcome [6] 0 0
Changes in Eosinophilic Cationic protein levels
Timepoint [6] 0 0
Baseline to day 112

Eligibility
Key inclusion criteria
1. Normal healthy volunteers, age at screening 18 to 65 years, inclusive.
2. Determined by the Investigator to be in good health, as documented by medical history, physical examination (including, but not limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), vital sign assessments, clinical laboratory assessments, and by general observations.
3. Participants must weigh at least 50 kg and have a Body Mass Index (BMI) between 18 and 30 kg/m2 Inclusive.
4. Participants must have clinical laboratory values within <1.5 x upper limit of normal (ULN) as specified by the testing laboratory, unless deemed not clinically significant by the Investigator.
5. Consumed an average of no more than 3 drinks per day within the 6 months prior to administration of study drug (beer [284 mL], wine [125 mL] or distilled spirits [25 mL]).
6. Participants must have a negative urine drug screen /alcohol breath test at screening and Day -1.
7. Stool sample negative for parasites.
8. Participants must have the ability and willingness to attend the necessary visits to the study centre.
9. Written informed consent signed prior to entry into the study.
10. Participants must be able to communicate effectively with the study site personnel.
11. Participants using highly effective, double barrier contraception (both male and female partners) during the study and for 90 days following the dose of AK002
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
2. The participant has any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will complete the study.
3. The participant has evidence of any medical or surgical disease or condition which, in the opinion of the Investigator, might compromise the haematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, skeletal, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of AK002, or would place the participant at increased risk.
4. The participant has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1
5. Use of any new drugs (including prescription and over-the-counter drugs and herbal supplements) within 1 week or 5 half-lives (whichever is longer), prior to administration of study drug.
6. Use of any prescription medication or neutraceuticals within 30 days of randomization.
7. Use of over-the counter medication (with the exception of paracetamol), vitamin supplements, or herbal medicines within 7 days of randomization.
8. Participants who initiated immunotherapy 90 days or more before the Screening visit and have been on a monthly regimen for allergy prevention or treatment may be considered for inclusion,
9. Use of immunosuppressants, oral corticosteroids, angiotensin converting enzyme (ACE) inhibitors or beta blockers within 2 weeks or 5 half-lives (whichever is longer), prior to Screening.
10. Any clinically significant laboratory abnormality or ECG.
11. The participant has a known hypersensitivity to any component of the formulation of AK002.
12. Absolute neutrophil count <1500/microliter.
13. Aspartate aminotransferase (AST) or alanine transaminase (ALT) >1.5 x ULN unless deemed not clinically significant by Investigator discretion.
14. The participant has history or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration, or is unwilling to agree to abstain from alcohol limitations and drugs throughout the study.
15. The participant has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 3 months prior to Check-in (Day -1). Cotinine urine test is positive at Screening or Check-in (Day -1).
16. The participant has poor peripheral venous access.
17. Blood donation or significant blood loss (more than 500 mL) within 60 days
18. Plasma donation within 7 days prior to Day 1.
19. Administration of Investigational Product (IP) in another trial within 30 days prior to the first study drug administration (or within 5 half lives of the drug, whichever is longer).
20. Females who are pregnant or lactating or intend to become pregnant before, during, or within 90 days after participating in this study; or intending to donate ova during such time period.
21. Surgery within the past three months prior to the first study drug administration determined by the PI to be clinically relevant.
22. Failure to satisfy the PI of fitness to participate for any other reason.
23. History of severe allergic or anaphylactic reactions.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/05/2017
Sample size
Target
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Nucleus Network Limited - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Allakos Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Single-centre, randomised, double blind, placebo controlled, single ascending dose study and multiple dose study. AK002 will be administered as an intra-venous (IV) infusion in eight cohorts of single escalating doses and two cohorts with multiple doses. The study will comprise of 3 parts: Part A (Cohorts 1 - single ascending dose); Part B (Cohorts 2 to 9 - single ascending dose); Part C (Cohorts 10 and 11 - multiple dose).
Trial website
https://clinicaltrials.gov/study/NCT02859701
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jason Lickliter, MBBS PhD
Address 0 0
Nucleus Network Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02859701