NCT04324268 is a Phase 1 clinical trial of lirentelimab (AK002) in Study Conducted in Healthy Volunteers, sponsored by Allakos Inc..

Who is sponsoring NCT04324268?

NCT04324268 is sponsored by Allakos Inc..

What drugs are being tested in NCT04324268?

Interventions in NCT04324268: lirentelimab (AK002), Placebo.

What condition does NCT04324268 study?

NCT04324268 studies Study Conducted in Healthy Volunteers.

Is NCT04324268 still recruiting?

NCT04324268 is currently completed. Last updated 18 April 2023.

Last reviewed 2023-04-18 · How we verify

NCT04324268

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 18 April 2023

What this trial tests

Phase 1 trial testing lirentelimab (AK002) in Study Conducted in Healthy Volunteers in 66 participants. Completed in 10 February 2021.

Timeline

23 March 2020

Primary endpoint
10 February 2021

10 February 2021

Quick facts

Lead sponsor	Allakos Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	other
Enrollment	66
Start date	23 March 2020
Primary completion	10 February 2021
Estimated completion	10 February 2021
Sites	1 location across United States

Drugs / interventions tested

lirentelimab (AK002) — full drug profile →
Placebo

Conditions studied

Study Conducted in Healthy Volunteers — all drugs for Study Conducted in Healthy Volunteers →

Sponsor

Allakos Inc. — full company profile →

Who can join

Adults 18 to 65, any sex, with Study Conducted in Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Therapeutic monoclonal antibodies in allergy: Targeting IgE, cytokine, and alarmin pathways.
Eggel A, Pennington LF, Jardetzky TS. · · 2024 · cited 45× · PMID 39158477 · DOI 10.1111/imr.13380
Siglecs in allergy and asthma.
Bochner BS, O'Sullivan JA, Chang AT, Youngblood BA. · · 2023 · cited 18× · PMID 35835621 · DOI 10.1016/j.mam.2022.101104
Lessons learned from targeting eosinophils in human disease.
Kuang FL, Bochner BS. · · 2021 · cited 9× · PMID 33891135 · DOI 10.1007/s00281-021-00849-w

Verify or expand the search:

Other trials of lirentelimab (AK002)

Trials testing the same drug.

NCT04322708 — A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Esophagitis · Phase 2, PHASE3 · completed
NCT04322604 — A Study to Assess AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic G · Phase 3 · completed

Other Allakos Inc. trials

Trials by the same sponsor.

NCT06577116 — Open-Label Extension Study for Subjects With H1 Antihistamine Refractory Chronic Spontaneous Urticaria Completing Study · Phase 1 · completed
NCT06072157 — Study to Assess the Safety, Tolerability, Pharmacokinetics and Immunogenicity of AK006 in Healthy Subjects and Subjects · Phase 1 · completed
NCT05528861 — A Study to Assess Subcutaneous Lirentelimab (AK002) in Chronic Spontaneous Urticaria · Phase 2 · terminated
NCT05155085 — A Study to Assess Subcutaneous Lirentelimab (AK002) in Atopic Dermatitis · Phase 2 · terminated
NCT04856891 — A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Duodenitis · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04324268 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Allakos Inc.
Last refreshed: 18 April 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04324268.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing