Trials / Terminated
TerminatedNCT03485053
A Single Ascending Study of IOP Injection in Patients With Iron Deficient Anemia
2 Part, Phase II Study of Intravenous, Single Ascending Dose Administrations of IOP Injection in Patients With Iron Deficient Anemia
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- MegaPro Biomedical Co. Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose is to evaluate the efficacy and safety of IOP Injection (MPB-1514) for the treatment of iron-deficient anemia (IDA).
Detailed description
The Phase II study is to establish the maximum tolerated dose of i.v. IOP Injection (MPB-1514) in Part 1 and to evaluate the safety and efficacy of the maximally tolerated dose of IOP Injection with different infusions schemes in Part 2.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IOP Injection / MPB-1514 | Dilute with 5% Dextrose solution (D5W) |
Timeline
- Start date
- 2018-11-29
- Primary completion
- 2020-09-30
- Completion
- 2021-08-31
- First posted
- 2018-04-02
- Last updated
- 2021-10-28
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03485053. Inclusion in this directory is not an endorsement.