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

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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

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