WHO ICTRP trial
An RSV Human Challenge Study of Palivizumab in Healthy Adult Participants
EUCTR2020-001044-26-GB · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2020-001044-26-GB |
|---|---|
| Public title | An RSV Human Challenge Study of Palivizumab in Healthy Adult Participants |
| Scientific title | A Double-Blind, Randomised, Placebo-Controlled Exploratory Study to Estimate the Prophylactic Efficacy of Palivizumab in Healthy Adult Participants Inoculated with Respiratory Syncytial Virus (RSV) - An RSV Human Challenge Study of Palivizumab in Healthy Adult Participa |
| Primary sponsor | mAbxience Research S.L. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | United Kingdom |
| Conditions | Respiratory Syncytial Virus Infection MedDRA version: 20.0 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Virus Diseases… |
| Interventions | Trade Name: Synagis Product Name: Synagis Pharmaceutical Form: Solution for injection/infusion Pharmaceutical form of the placebo: Solution for injection/infusion Route of administration of the placebo: Intravenous use |
| Registration date | Jun 24, 2020 |
| Target size | 56 |
| Secondary IDs | MB05-P-01-20 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: