Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05987072

A Study to Learn How the Study Medicine Called Sisunatovir is Tolerated and Acts in the Bodies of Chinese Healthy Adults.

Respiratory Syncytial Virus Infection Clinical Trial

Official title:
A PHASE 1, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY FOLLOWING SINGLE AND MULTIPLE DOSES OF SISUNATOVIR IN CHINESE HEALTHY PARTICIPANTS

Clinical Trial Summary

The purpose of the study is to learn about: - The activity of sisunotavir in the body over a period. It includes the processes by which sisunotavir is absorbed, distributed in the body, localized in the tissues, and removed from the body. - safety and tolerability of sisunatovir (PF-07923568) in Chinese healthy adult participants. This information is being collected to support further clinical development as well as medicine registration in China. This study is seeking for participants who: - are male and female participants aged 18 to 65 years of age. - are male and female participants who are healthy as seen by medical tests. - have body mass index (BMI) of 19 to 27 kg/m2 and a total body weight of more than 50 kilograms (110 pounds). About 12 participants will receive sisunatovir. Four capsules (strength=50 milligrams, 200 milligrams in total) of Sisunatovir will be given on Day 1 on empty stomach. This will be followed by 8 capsules of sisunatovir with 12 hours gap in between four capsules from Days 4 to 7. The participants will have to take 4 capsules of sisunatovir in the morning of 8th day with a meal. The total time of participants will be in the study is about 71 days. This includes the screening visit to the Follow-up contact. In screening visit, participants will be tested to see if they are fit to take part in the study.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Respiratory Syncytial Virus Infection
  • Respiratory Syncytial Virus Infections
Clinical Trial Details
NCT number NCT05987072
Study type Interventional
Source Pfizer
Contact
Status Completed
Phase Phase 1
Start date November 3, 2023
Completion date December 31, 2023
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 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
Completed NCT01909843 - ALX-0171 Safety Study in Adults With Hyperresponsive Airways Phase 1
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