A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AK001

A

Allakos

Status and phase

Completed
Phase 1

Conditions

Atopy

Treatments

Drug: Placebo
Drug: AK001

Study type

Interventional

Funder types

Industry

Identifiers

NCT02563938
AK001-001

Details and patient eligibility

About

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.

Full description

AK001 is a monoclonal antibody which may be useful in the treatment of patients with severe allergic diseases.

Enrollment

34 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

34 participants in 2 patient groups, including a placebo group

AK001
Experimental group
Description:
Up to six single ascending doses of AK001.
Treatment:
Drug: AK001
Saline Solution
Placebo Comparator group
Description:
Saline solution will be administered as a single infusion.
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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