NCT04540042

Study to Assess the Safety and Efficacy of SelK2 on Airway Responses Following Allergen Challenge in Subjects With Asthma (Part 1) and in Subjects With Chronic Obstructive Pulmonary Disease (Part 2)

A Two Part, Randomised, Double-blind, Placebo-controlled, Phase 2 Parallel Group Study to Evaluate the Safety and Efficacy of Intravenously-Administered SelK2 on Airway Responses Following Allergen Challenge in Subjects With Asthma (Part 1) and to Evaluate the Safety and Efficacy of Intravenously-Administered SelK2 in Subjects With Chronic Obstructive Pulmonary Disease (Part 2)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Tetherex Pharmaceuticals Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study has two parts. The main purpose of Part 1 of this study will be to examine how safe and effective two doses of SelK2 is on participants with mild asthma. Lung function and inflammatory cell numbers will be measured in response to the administration of an allergen (a compound to which the participant is allergic) into the lungs in the presence or absence of SelK2. Part 2 of this study will examine how safe and effective one dose of SelK2 is on participants with chronic obstructive pulmonary disease (COPD). Lung function and inflammatory cell numbers will be measured in COPD patients in the presence or absence of SelK2. SelK2 may block the movement of key inflammatory cells into the lungs and consequently improve lung function in these two patient populations.

Conditions

• Asthma
• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	SelK2 (Part 1)	I.V., multiple-dose (Day 1 and Day 22)
DRUG	Placebo (Part 1)	I.V., multiple-dose (Day 1 and Day 22)
DRUG	SelK2 (Part 2)	I.V., single-dose (Day 1)
DRUG	Placebo (Part 2)	I.V., single-dose (Day 1)

Timeline

• Start date: 2020-08-18
• Primary completion: 2021-12-21
• Completion: 2022-01-13
• First posted: 2020-09-07
• Last updated: 2022-02-02

Locations

2 sites across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study