Title

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AK001
A Phase 1, Randomized, Double-Blind, Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AK001 in Subjects With Atopic Disease
  • Phase

    Phase 1
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Indication/Condition

    Atopy
  • Intervention/Treatment

    ak001 ...
  • Study Participants

    34
This first-in-human study will evaluate the safety and tolerability of single doses of AK001 across a range of potentially active doses. Early signals of pharmacodynamic activity will also be evaluated.
AK001 is a monoclonal antibody which may be useful in the treatment of patients with severe allergic diseases.
Study Started
Sep 30
2015
Primary Completion
Mar 31
2016
Study Completion
Mar 31
2016
Last Update
Jun 29
2016
Estimate

Drug AK001

Given parenterally.

Drug Placebo

  • Other names: Saline solution

AK001 Experimental

Up to six single ascending doses of AK001.

Saline Solution Placebo Comparator

Saline solution will be administered as a single infusion.

Criteria

Inclusion Criteria:

BMI between 18-30
Determined to be in good health
Clinical laboratory values within limits of normal values
Normal 12-lead ECG
Stool sample negative for parasites
Non-smoker
Consumed an average of no more than 2 drinks per day within 6 months
Subjects of reproductive age must use a highly effective method of contraception
Positive skin test in certain cohorts
Elevated total eosinophil counts in certain cohorts

Exclusion Criteria:

Clinically significant medical history conditions or laboratory values
Receipt of investigational drug, biologic or medical device within 30 days prior to Screening
New drug therapy within 1 week of study drug administration
Antihistamine use within 2 weeks prior to Screening
Consumption of alcohol within 48 hours of study drug administration
Positive urine drug test or cotinine test at Screening or Day -1
History, within the last 2 years, of alcohol abuse, illicit drug use, or significant mental illness
Demonstration of veins unsuitable for repeated venipuncture or IV infusion
Recent treatment with alternative therapies which may confound clinical or laboratory assessments
Donation or loss of more than 500 mL of blood within 56 days prior to study drug administration
History of malignancy within last 5 years
History of severe allergic or anaphylactic reactions
Females who are pregnant or breastfeeding
No Results Posted