A Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With RSV Lower Respiratory Tract Infection to Evaluate the Safety, Tolerability, and Clinical Activity of ALX-0171

Phase 1

Completed

• Conditions: Respiratory Syncytial Virus Infection
• Interventions: Other: Placebo; Biological: ALX-0171

• Registration Number: NCT02309320
• Lead Sponsor: Ablynx, a Sanofi company

Brief Summary

The primary objective of the study is to investigate the safety and tolerability of ALX-0171.

The secondary objectives are to evaluate the clinical effect of ALX-0171 and to explore the pharmacodynamics (PD) and the systemic pharmacokinetics (PK) of ALX-0171.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-27
• Study Start: 2014-12
• Study First Submitted QC: 2014-12-04
• Study First Posted: 2014-12-05
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-09
• Last Update Posted: 2019-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

1. Subject is otherwise healthy, but hospitalised for and clinically diagnosed with RSV LRTI (Lower Respiratory Tract Infection)
2. Subject has appearance of upper or lower respiratory tract infection symptoms that are likely related to RSV
3. Subject has a positive RSV diagnostic test
4. Others as defined in the protocol

Exclusion Criteria

1. Subject has history of wheezing
2. Subject is known to have significant comorbidities
3. Subject is known to be immunocompromised
4. Subject is suspected of having a clinically relevant infection other than RSV
5. Others as defined in the protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Inhalation of Placebo during 3 consecutive days
ALX-0171	ALX-0171	Inhalation of ALX-0171 during 3 consecutive days

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability as measured by the incidence of treatment emergent adverse events, clinical laboratory parameters and physical examination	1 day before first dose to 14 days after first dose

Secondary Outcome Measures

Name	Time	Method
Immunogenicity as measured by the concentration of anti-drug antibodies in serum	1 day before first dose to 14 days after first dose
Clinical activity as measured by the evaluation of the clinical response of the subjects	1 day before first dose to 14 days after first dose
Exploratory Pharmacokinetics as measured by the concentration of ALX-0171 in serum	Day 3
Exploratory Pharmacodynamics as measured by the concentration of viral load in respiratory secretions and exploratory biomarkers in serum	1 day before first dose to 14 days after first dose

Trial Locations

Locations (10)

Investigator Site 4; 🇬🇧 Kent, United Kingdom

Investigator Site 2; 🇬🇧 City Of Edinburgh, United Kingdom

Investigator Site 1; 🇬🇧 Oxford, United Kingdom

Investigator Site 3; 🇬🇧 Tooting, United Kingdom

Investigator Site 5; 🇬🇧 Liverpool, United Kingdom

Investigator Site 6; 🇬🇧 Nottingham, United Kingdom

Investigator Site; 🇹🇭 Khon Kaen, Thailand

Investigator Site 7; 🇪🇸 Malaga, Spain

Investigators Site 3; 🇭🇺 Budapest, Hungary

Investigator Site 8; 🇪🇸 Sevilla, Spain