Trials / Terminated
TerminatedNCT02481180
Tolerance, Pharmacokinetics and Preliminary Efficacy of T0001 in RA (Rheumatoid Arthritis)
An Open, Dose Escalation, Multiple Dose Study to Assess Tolerance、Pharmacokinetics、Preliminary Efficacy of T0001 in RA (Rheumatoid Arthritis)
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the MTD, Pharmacokinetics and preliminary efficacy of T0001 in Rheumatoid Arthritis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | T0001 | injection (SC) T0001 15mg weekly for 12 weeks |
| DRUG | T0001 | injection (SC) T0001 30mg weekly for 12 weeks |
| DRUG | T0001 | injection (SC) T0001 30mg every two weeks for 12 weeks |
| DRUG | T0001 | injection (SC) T0001 50mg every two weeks for 12 weeks |
| DRUG | Enbrel | injection (SC) enbrel 50mg twice a week for 12 weeks |
Timeline
- Start date
- 2015-07-31
- Primary completion
- 2017-11-06
- Completion
- 2017-11-06
- First posted
- 2015-06-25
- Last updated
- 2019-07-08
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02481180. Inclusion in this directory is not an endorsement.