NCT03096795

Safety and Tolerability of MEDI3506 in Healthy Participants, in Participants With COPD and Healthy Japanese Participants

Completed Phase 1 Last updated 5 October 2020

What this trial tests

Phase 1 trial testing MEDI3506 in Part I (SAD) - Healthy Participants in 88 participants. Completed in 30 September 2019.

Timeline

15 May 2017

Primary endpoint
30 September 2019

30 September 2019

Quick facts

Lead sponsor	MedImmune LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	88
Start date	15 May 2017
Primary completion	30 September 2019
Estimated completion	30 September 2019
Sites	2 locations across United Kingdom

Drugs / interventions tested

• MEDI3506 — full drug profile →
• Placebo

Conditions studied

• Part I (SAD) - Healthy Participants — all drugs for Part I (SAD) - Healthy Participants →
• Part II (MAD) - Chronic Obstructive Pulmonary Disease — all drugs for Part II (MAD) - Chronic Obstructive Pulmonary Disease →
• Part III (J-SD) - Healthy Japanese Participants — all drugs for Part III (J-SD) - Healthy Japanese Participants →

Sponsor

MedImmune LLC — full company profile →

Who can join

Adults 18 to 80, any sex, with Part I (SAD) - Healthy Participants or Part II (MAD) - Chronic Obstructive Pulmonary Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 1, randomised, blinded, placebo controlled, study designed to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity response to single and multiple doses of MEDI3506.

Publications & conference data

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

1. Tozorakimab (MEDI3506): an anti-IL-33 antibody that inhibits IL-33 signalling via ST2 and RAGE/EGFR to reduce inflammation and epithelial dysfunction.
   England E, Rees DG, Scott IC, Carmen S, et al · · 2023 · cited 85× · PMID 37330528 · DOI 10.1038/s41598-023-36642-y
2. The use of biologics for immune modulation in allergic disease.
   van de Veen W, Akdis M. · · 2019 · cited 45× · PMID 30882368 · DOI 10.1172/jci124607
3. Angiogenesis, Lymphangiogenesis, and Inflammation in Chronic Obstructive Pulmonary Disease (COPD): Few Certainties and Many Outstanding Questions.
   Poto R, Loffredo S, Palestra F, Marone G, et al · · 2022 · cited 32× · PMID 35626756 · DOI 10.3390/cells11101720
4. IL33 and Mast Cells-The Key Regulators of Immune Responses in Gastrointestinal Cancers?
   Eissmann MF, Buchert M, Ernst M. · · 2020 · cited 31× · PMID 32719677 · DOI 10.3389/fimmu.2020.01389
5. A Randomized Phase I Study of the Anti-Interleukin-33 Antibody Tozorakimab in Healthy Adults and Patients With Chronic Obstructive Pulmonary Disease.
   Reid F, Singh D, Albayaty M, Moate R, et al · · 2024 · cited 27× · PMID 38115209 · DOI 10.1002/cpt.3147
6. The Role of IL-33/ST2 in COPD and Its Future as an Antibody Therapy.
   Riera-Martínez L, Cànaves-Gómez L, Iglesias A, Martin-Medina A, et al · · 2023 · cited 27× · PMID 37240045 · DOI 10.3390/ijms24108702
7. Targeting the Epithelium-Derived Innate Cytokines: From Bench to Bedside.
   Ham J, Shin JW, Ko BC, Kim HY. · · 2022 · cited 21× · PMID 35291657 · DOI 10.4110/in.2022.22.e11
8. IL-33/ST2 axis in diverse diseases: regulatory mechanisms and therapeutic potential.
   Sheng F, Li M, Yu JM, Yang SY, et al · · 2025 · cited 16× · PMID 39925809 · DOI 10.3389/fimmu.2025.1533335