Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AK002 in Healthy Participants

NCT02859701 | Completed Phase 1

• 1 other identifier: AK002-002
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of AK002 as assessed by incidence, nature and severity of AEs and SAEs.

  Screening to day 112

Secondary Outcomes (6)

• Evaluate pharmacokinetic parameter AUC for AK002.

  Baseline to Day 112

• Change from baseline of absolute peripheral blood counts of eosinophils.

  baseline to Day 112

• Change from baseline of absolute peripheral blood counts of basophils.

  baseline to Day 112

• Changes in serum tryptase levels

  baseline to Day 112

• Evaluate pharmacokinetic parameter CMAX for AK002.

  baseline to day 112

Study Arms (2)

AK002

EXPERIMENTAL

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

Drug: AK002

Placebo

PLACEBO COMPARATOR

Placebo administered as anl IV infusion

Other: Placebo

Interventions

AK002 DRUG

IV AK002

AK002

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Normal healthy volunteers, age at screening 18 to 65 years, inclusive.
• 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.
• Participants must weigh at least 50 kg and have a Body Mass Index (BMI) between 18 and 30 kg/m2 Inclusive.
• 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.
• 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 \[25 mL\]).
• Participants must have a negative urine drug screen /alcohol breath test at screening and Day -1.
• Stool sample negative for parasites.
• Participants must have the ability and willingness to attend the necessary visits to the study centre.
• Written informed consent signed prior to entry into the study.
• Participants must be able to communicate effectively with the study site personnel.
• Participants using highly effective, double barrier contraception (both male and female partners) during the study and for 90 days following the dose of AK002

You may not qualify if:

• Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
• 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.
• 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.
• 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
• 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.
• Use of any prescription medication or neutraceuticals within 30 days of randomization.
• Use of over-the counter medication (with the exception of paracetamol), vitamin supplements, or herbal medicines within 7 days of randomization.
• 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.
• Any clinically significant laboratory abnormality or ECG.
• The participant has a known hypersensitivity to any component of the formulation of AK002.
• Absolute neutrophil count \<1500/microliter.
• Aspartate aminotransferase (AST) or alanine transaminase (ALT) \>1.5 x ULN unless deemed not clinically significant by Investigator discretion.
• 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.
• 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).
• The participant has poor peripheral venous access.

Sponsors & Collaborators

• Allakos Inc.: lead

Study Sites (1)

Nucleus Network Limited

Melbourne, Australia

Location

MeSH Terms

Interventions

AK002

Study Officials

• Jason Lickliter, MBBS PhD

  Nucleus Network Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: August 9, 2016
• Study Start: August 1, 2016
• Primary Completion: May 17, 2017
• Study Completion: May 17, 2017
• Last Updated: September 26, 2017

Record last verified: 2017-09

Locations

AU (1)