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

NCT02563938 | Completed Phase 1

• 1 other identifier: AK001-001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopy

Outcome Measures

Primary Outcomes (1)

• Evaluation of safety and tolerability of AK001 measured by number of subjects with adverse events and dose limiting toxicities (DLTs) respectively

  Within 86 days

Secondary Outcomes (4)

• Immediate hypersensitivity skin testing

  Within 28 days

• Peripheral blood counts for eosinophils and basophils

  Within 28 days

• Serum eosinophilic cationic protein (ECP) and tryptase levels

  Within 28 days

• 24-hour urine measurement of histamine, N-methylhistamine, and 11-beta-prostaglandin F2

  Within 28 days

Study Arms (2)

AK001

EXPERIMENTAL

Up to six single ascending doses of AK001.

Drug: AK001

Saline Solution

PLACEBO COMPARATOR

Saline solution will be administered as a single infusion.

Drug: Placebo

Interventions

AK001 DRUG

Given parenterally.

AK001

Placebo DRUG

Also known as: Saline solution

Saline Solution

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allakos Inc.: lead

Study Sites (1)

Unknown Facility

Cypress, California, United States

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Study Director

  Allakos Inc.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: September 30, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: June 29, 2016

Record last verified: 2016-06

Locations

US (1)