Trials / Completed
CompletedNCT04123886
A Phase I Study Evaluating SCB-313(Recombinant Human TRAIL-Trimer Fusion Protein) for the Treatment of Malignant Pleural Effusion
A Phase I Study Evaluating the Safety, Tolerability and Pharmacokinetics of SCB-313, Recombinant Human Tumor Necrosis Factor-Related Apoptosis-Inducing Ligand-Trimer Fusion Protein, for the Treatment of Malignant Pleural Effusion
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Sichuan Clover Biopharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety and tolerability of single dose of SCB-313 by intrapleural injection.To evaluate the safety and tolerability of repeated dose of SCB-313 by intrapleural injection once a day for 3 days, and to determine the maximum tolerated dose (MTD) of SCB-313.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SCB-313 | SCB-313 Intrapleural injection, once daily. Single dose on Day 1 in Cycle 0 followed by 7-day safety assessment, then dose on Day 1,2,3 in Cycle 1 followed by 21-day observation . |
Timeline
- Start date
- 2020-01-08
- Primary completion
- 2021-09-30
- Completion
- 2022-03-31
- First posted
- 2019-10-11
- Last updated
- 2022-05-06
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04123886. Inclusion in this directory is not an endorsement.