Clinical Trials Logo
  1. Home
  2. Other
  3. NCT01909843

ALX-0171 Safety Study in Adults With Hyperresponsive Airways

Respiratory Syncytial Virus Infection Clinical Trial

Official title:
A Phase I, Single-centre, Open Label Study to Evaluate the Potential Occurrence, Reversibility and Prevention of Bronchoconstriction as Individual Response to Escalating Doses Followed by Repeated Doses of ALX-0171, Administered by Oral Inhalation to Adults With Hyperresponsive Airways

Clinical Trial Summary

This is a Phase I, single-centre, open label study to evaluate the occurrence and subsequent reversibility and prevention, of bronchoconstriction following single and repeated oral inhalations of ALX-0171 in adults with hyperresponsive airways.

This phase I study is an exploratory study and serves to evaluate the occurrence and reversibility of bronchoconstriction upon inhalation of ALX-0171. The study is an open label trial with a sequential administration regimen of placebo and verum in all planned study subjects. Each subject will start the treatment with a single dose of ALX-0171 placebo (= formulation buffer) followed by escalating doses of ALX-0171 verum.

Eventually a second administration of ALX-0171 placebo may take place at the end of the study (as defined per protocol).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Respiratory Syncytial Virus Infection
  • Respiratory Syncytial Virus Infections
  • Virus Diseases
Clinical Trial Details
NCT number NCT01909843
Study type Interventional
Source Ablynx
Contact
Status Completed
Phase Phase 1
Start date July 2013
Completion date December 2013
View Details
See also
  Status Clinical Trial Phase
Completed NCT02016690 - Synagis® Liquid 50mg, 100mg for Intramuscular Injection Special Investigation in Immuno Compromised Children With Synagis N/A
Completed NCT01107535 - Effectiveness of Synagis (Palivizumab) Immunoprophylaxis in Preterm Infants With High Risk of Severe Respiratory Syncytial Virus (RSV) Infection N/A
Completed NCT04491877 - Study of an Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers Phase 1/Phase 2
Completed NCT05987072 - A Study to Learn How the Study Medicine Called Sisunatovir is Tolerated and Acts in the Bodies of Chinese Healthy Adults. Phase 1
Completed NCT01006629 - Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children Phase 2/Phase 3
Completed NCT00593918 - Innate Immunity and Respiratory Syncytial Virus (RSV) Infection in Children N/A
Recruiting NCT06134648 - Study of a Respiratory Syncytial Virus/Human Metapneumovirus Vaccine Candidate Phase 1/Phase 2
Completed NCT03473002 - A Safety and Immunogenicity Study of Intranasal Sendai Virus Vectored Respiratory Syncytial Virus (SeVRSV) Vaccine in Healthy Adults Phase 1
Completed NCT02135614 - Efficacy, Pharmacokinetics, and Safety of Presatovir in Hospitalized Adults With Respiratory Syncytial Virus (RSV) Infection Phase 2
Recruiting NCT06206720 - A Study of Deuremidevir Hydrobromide for Suspension in Chinese Infants Hospitalized With RSV Phase 2
Completed NCT02254421 - Presatovir in Hematopoietic Cell Transplant Recipients With Respiratory Syncytial Virus (RSV) Infection of the Lower Respiratory Tract Phase 2
Recruiting NCT06237296 - Study of the Safety and Immune Response of an Investigational mRNA Vaccine for the Prevention of Respiratory Syncytial Virus and/or Human Metapneumovirus in Participants Aged 18 to 49 Years and 60 Years and Older Phase 1
Completed NCT01537198 - Surveillance of Synagis in Korean Pediatric Patients N/A
Active, not recruiting NCT05687279 - Study on a Live-attenuated Respiratory Syncytial Virus Vaccine for Assessment of Safety, Transmissibility, and Genetic Stability of the Vaccine Virus Among Close Contacts in Infants and Toddlers 6 to < 24 Months of Age in Puerto Rico (USA) Phase 1/Phase 2
Completed NCT01297504 - A One-Year Observation of Palivizumab in Infants at Risk for Respiratory Syncytial Virus Infection in Latin America N/A
Recruiting NCT06079320 - A Study to Learn About the Study Medicine Sisunatovir in Adults With Respiratory Syncytial Virus (RSV) Infection Phase 2/Phase 3
Completed NCT06424795 - Molecular and Microbiome/Metagenome Correlates of Recurrent Wheeze in RSV Infected Infants
Completed NCT02309320 - 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/Phase 2
Recruiting NCT06194318 - First-in-human Safety and Immunogenicity Study of SCB-1019 in Healthy Adults Phase 1
Completed NCT01466062 - Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less With Immunocompromised Medical Conditions Phase 3