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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)

NCT04540042 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2022-02-02

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • Tetherex Pharmaceuticals Corporation

    lead INDUSTRY

Principal Investigators

  • Jonathan Stocker, Ph.D. · Tetherex Pharmaceuticals Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-18
Primary Completion
2021-12-21
Completion
2022-01-13
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04540042 on ClinicalTrials.gov