A Study to Evaluate Safety, Tolerability, and Bioavailability of Subcutaneous Lirentelimab (AK002) in Adult Healthy Volunteers

April 17, 2023 updated by: Allakos Inc.

A Phase 1 Study to Evaluate Safety, Tolerability, and Bioavailability of Subcutaneously Administered Lirentelimab (AK002) in Adult Healthy Volunteers

This is a Phase 1, single-center study to evaluate safety, tolerability, and bioavailability of subcutaneously administered lirentelimab (AK002) in adult healthy volunteers. Subjects will receive a single dose of intravenous AK002 or subcutaneous lirentelimab (AK002) assigned in a double-blind, randomized fashion.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Edgewater, Florida, United States, 32132
        • Allakos Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Provided written informed consent.
  2. Male or female aged ≥18 and ≤65 years at the time of signing the ICF.
  3. Determined by the Investigator to be in good health as documented by medical history, vital signs, physical examination, laboratory assessments, ECG, and by general observations.
  4. Subjects must weigh at least 50 kg and have a BMI between 18 g/m2 and 30 kg/m2, inclusive.
  5. Negative urine drug screen at Screening.
  6. Subjects must have the ability and willingness to attend the necessary visits to the study center and the ability to communicate effectively with the study site personnel.
  7. Negative screening ova and parasite test.
  8. Female subjects must be either post-menopausal for at least 1 year with FSH level >40 IU/mL at Screening or surgically sterile (tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 3 months, or if of childbearing potential, have a negative pregnancy test and agree to use dual methods of contraception, or abstain from sexual activity from Screening until the end of the study, or for 120 days following the last dose of study drug, whichever is longer.
  9. Male subjects with female partners of childbearing potential must agree to use a highly effective method of contraception from Screening until the end of the study or for 120 days following the last dose of study drug, whichever is longer. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant (e.g., missed or late menstrual period) at any time during study participation.

Exclusion Criteria:

  1. Peripheral blood absolute eosinophil count >300/µL.
  2. Known hypersensitivity to any constituent of the study drug.
  3. Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
  4. Presence of abnormal laboratory values considered to be clinically significant by the Investigator.
  5. Any disease of condition (medical or surgical) which, in the opinion of the Investigator, would place the subject at increased risk.
  6. History of malignancy except carcinoma in situ in the cervix, early stage prostate cancer, or non-melanoma skin cancers.
  7. Treatment with chemotherapy or radiotherapy in the preceding 6 months.
  8. Treatment for a helminthic parasitic infection within 6 months of screening.
  9. Use during the 30 days before Screening (or 5 half-lives, whichever is longer) or use during the Screening period of omalizumab, dupilumab, systemic immunosuppressive drugs, or systemic corticosteroids, except if receiving as part of a premedication protocol.
  10. Vaccination with live attenuated vaccines within 30 days prior to initiation of treatment in the study, during the treatment period, or vaccination expected within 5 half-lives (4 months) of study drug administration.
  11. Positive hepatitis serology results, except for vaccinated subjects or subjects with past but resolved hepatitis, at Screening.
  12. Positive HIV serology results at Screening.
  13. Alcohol, drug, or other substance abuse or dependence.
  14. Any other reason that, in the opinion of the Investigator or Medical Monitor, makes the subject unsuitable for enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Other: Placebo
Placebo
Experimental: SC 0.3 mg/kg of lirentelimab (AK002)
Subjects in this arm will receive a single dose of 0.3 mg/kg of lirentelimab (AK002) administered subcutaneously.
Drug: lirentelimab (AK002)
Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
Experimental: SC 1 mg/kg of lirentelimab (AK002)
Subjects in this arm will receive a single dose of 1 mg/kg of lirentelimab (AK002) administered subcutaneously.
Drug: lirentelimab (AK002)
Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
Experimental: SC 3 mg/kg of lirentelimab (AK002)
Subjects in this arm will receive a single dose of 3 mg/kg of lirentelimab (AK002) administered subcutaneously.
Drug: lirentelimab (AK002)
Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
Experimental: SC 5 mg/kg of lirentelimab (AK002)
Subjects in this arm will receive a single dose of 5 mg/kg of lirentelimab (AK002) administered subcutaneously.
Drug: lirentelimab (AK002)
Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
Experimental: IV 1 mg/kg of lirentelimab (AK002)
Subjects in this arm will receive a single dose of 1 mg/kg of lirentelimab (AK002) administered intravenously.
Drug: lirentelimab (AK002)
Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
Experimental: IV 3 mg/kg of lirentelimab (AK002)
Subjects in this arm will receive a single dose of 3 mg/kg of lirentelimab (AK002) administered intravenously.
Drug: lirentelimab (AK002)
Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
Experimental: IV 3 mg/kg of lirentelimab (AK002) (Priming)
Subjects in this arm will receive a single dose of 3 mg/kg of lirentelimab (AK002) administered intravenously from an IV bag prepared with extra volume for priming IV set.
Drug: lirentelimab (AK002)
Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
Experimental: SC 300 mg of lirentelimab (AK002)
Subjects in this arm will receive a single dose of 300 mg of lirentelimab (AK002) administered subcutaneously.
Drug: lirentelimab (AK002)
Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
Experimental: SC 450 mg of lirentelimab (AK002)
Subjects in this arm will receive a total of 450 mg of lirentelimab (AK002), administered as two separate subcutaneous injections.
Drug: lirentelimab (AK002)
Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Safety and tolerability of lirentelimab (AK002) administered subcutaneously by evaluating adverse events assessed using the CTCAE version 5
Time Frame: Day 0 (baseline) to Day 85
Day 0 (baseline) to Day 85
Pharmacokinetics, including bioavailability, of lirentelimab (AK002) administered subcutaneously
Time Frame: Day 0 (baseline) to Day 85
Day 0 (baseline) to Day 85

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Pharmacodynamics of lirentelimab (AK002) SC formulation as measured by changes in absolute peripheral blood counts of esoinophils
Time Frame: Day 0 (baseline) to Day 85
Day 0 (baseline) to Day 85
Bioavailability of lirentelimab (AK002) SC formulation relative to lirentelimab (AK002) IV by analyzing the area under the serum AUC
Time Frame: Day 0 (baseline) to Day 85
Day 0 (baseline) to Day 85

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allakos Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Henrik Rasmussen, MD, PhD, Allakos Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 23, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 10, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 10, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AK002-017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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