WHO ICTRP trial
A MULTICENTRE, SAD, AND MAD CLINICAL TRIAL TO EVALUATE THE SAFETY, TOLERABILITY…
NL-OMON52682 · Overview of Medical Research in the Netherlands (NL-OMON) · Recruiting
Key facts
| Trial ID | NL-OMON52682 |
|---|---|
| Public title | A MULTICENTRE, SAD, AND MAD CLINICAL TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF IV TREATMENT OF CALY-002 IN HEALTHY SUBJECTS AND SUBJECTS WITH COELIAC DISEASE AND EOSINOPHILIC OESOPHAGITIS |
| Scientific title | A MULTICENTRE, SAD, AND MAD CLINICAL TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF IV TREATMENT OF CALY-002 IN HEALTHY SUBJECTS AND SUBJECTS WITH COELIAC DISEASE AND EOSINOPHILIC OESOPHAGITIS - CALY-CL19-001 |
| Primary sponsor | Calypso Biotech BV |
| Registry | Overview of Medical Research in the Netherlands (NL-OMON) |
| Recruitment status | Recruiting |
| Study type | Interventional |
| Countries | Belgium;Finland;Germany;Netherlands;Norway |
| Conditions | Allergic esophagus inflammation Coeliac disease Gluten intolerance; Eosinophilic oesophagitis;10017943;Allergic esophagus inflammation;Coeliac disease;Gluten intolerance; Eosinophilic oesophagitis |
| Interventions | Subjects in Cohorts B1 (70 mg dose) and B2 (210 mg dose) will receive the study drug (CALY-002 or placebo) IV once every 2 weeks (q2w) for 8 weeks (2 × 28-day treatment cycles; a total of 4 doses). All subjects in cohort C1 will receive IV… |
| Registration date | Nov 28, 2022 |
| Target size | 6 |
| Secondary IDs | 2020-000726-25;NL74371.056.20 |
| Registry page | onderzoekmetmensen.nl |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: