Fe 999301 (DrugBank: -)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 96 | クローン病 | 1 |
| 97 | 潰瘍性大腸炎 | 2 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2016-000205-36-DE (EUCTR) | 11/07/2016 | 14/03/2016 | A Clinical Trial to Evaluate Activity, Safety and Tolerability of FE 999301 by Intravenous Infusions in Patients with Active Inflammatory Bowel Disease (IBD). | A Single-Centre, Exploratory Trial to Assess the Mechanisms of Molecular Activity, Safety and Tolerability of One Dose Level of FE 999301 by Intravenous Infusions in Patients with Active Inflammatory Bowel Disease (IBD) - FUTURE | Inflammatory Bowel Disease (Crohn`s Disease and Ulcerative Colitis) MedDRA version: 19.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: FE 999301 | University Hospital Schleswig-Holstein (UKSH) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Germany |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03235752 (ClinicalTrials.gov) | February 6, 2018 | 28/7/2017 | Safety and Efficacy of TJ301 IV in Participants With Active Ulcerative Colitis | A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of TJ301 (FE 999301) Administered Intravenously in Patients With Active Ulcerative Colitis | Active Ulcerative Colitis | Drug: TJ301 300mg;Drug: TJ301 600mg;Drug: Placebo | I-Mab Biopharma HongKong Limited | NULL | Recruiting | 18 Years | 70 Years | All | 90 | Phase 2 | Australia;China;Korea, Republic of;Taiwan |
| 2 | EUCTR2016-000205-36-DE (EUCTR) | 11/07/2016 | 14/03/2016 | A Clinical Trial to Evaluate Activity, Safety and Tolerability of FE 999301 by Intravenous Infusions in Patients with Active Inflammatory Bowel Disease (IBD). | A Single-Centre, Exploratory Trial to Assess the Mechanisms of Molecular Activity, Safety and Tolerability of One Dose Level of FE 999301 by Intravenous Infusions in Patients with Active Inflammatory Bowel Disease (IBD) - FUTURE | Inflammatory Bowel Disease (Crohn`s Disease and Ulcerative Colitis) MedDRA version: 19.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: FE 999301 | University Hospital Schleswig-Holstein (UKSH) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Germany |