Spots Global Cancer Trial Database for A Study Investigate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Response of SLN124 in Adults With Alpha/Beta-thalassaemia and Very Low- and Low-risk Myelodysplastic Syndrome
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Trial Identification
Brief Title: A Study Investigate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Response of SLN124 in Adults With Alpha/Beta-thalassaemia and Very Low- and Low-risk Myelodysplastic Syndrome
Official Title: A Randomised, Single-blind, Placebo-controlled, Phase 1, Single-ascending and Multiple-dose Study in Adult Subjects With Alpha/Beta-thalassaemia and Very Low- and Low-risk Myelodysplastic Syndrome to Investigate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Response of SLN124.
Study ID: NCT04718844
Study Description
Brief Summary: This study will investigate the safety and tolerability of SLN124 in patients with Thalassaemia or patients with Very Low- and Low-risk Myelodysplastic Syndrome (MDS) after single ascending s.c. doses and multiple doses in healthy male and female subjects. Up to 7 cohorts of 56 patients with Thalassaemia and up to 7 cohorts of 56 patients with MDS will be enrolled. Each subject will receive single or multiple doses of SLN124 or placebo given by subcutaneous (s.c) injection.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Universitaetsklinikum Duesseldorf, Düsseldorf, , Germany
Universitat Leipzig, Leipzig, , Germany
Rambam Health Care Campus, Haifa, , Israel
Sheba Medical Center, Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Bar-Ilan University - Faculty of Medicine, Zefat, , Israel
AUSL della Romagna - Ospedale di Ravenna, Ravenna, , Italy
Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia, Reggio Emilia, , Italy
Jordan University Hospital, Amman, , Jordan
King Hussein Cancer Center, Amman, , Jordan
Irbid Speciality Hospital, Irbid, , Jordan
Sarawak General Hospital, Kampung Sarawak, , Malaysia
Hospital Ampang, Kampung Selangor, , Malaysia
King Chulalongkorn Memorial Hospital, Bangkok, , Thailand
Mahidol University - Faculty of Medicine - Ramathibodi Hospital, Bangkok, , Thailand
Mahidol University - Siriraj Hospital, Bangkok, , Thailand
Faculty of Medicine, Chiang Mai University, Chiang Mai, , Thailand
University Hospital of Wales, Cardiff, , United Kingdom
The Leeds Teaching Hospitals NHS Trust - Saint James's University Hospital, Leeds, , United Kingdom
Hammersmith Medicines Research Ltd (HMR), London, , United Kingdom
Contact Details
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