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NCT02312180 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study of ProMetic Plasminogen (Human) Intravenous in Adults and Children With Plasminogen Deficiency
A Phase 1 study, sponsored by Prometic Biotherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT02312180: Completed Phase 1 study, sponsored by Prometic Biotherapeutics.
NCT02312180 is a Phase 1 study that has completed, run by Prometic Biotherapeutics. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02312180, a Phase 1 study, has completed, sponsored by Prometic Biotherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
ProMetic is intiitating a first-in-man study entitled "A Phase 1, Dose Escalation, and Pharmacokinetic Study of ProMetic Plasminogen Administered as Intravenous Infusion in Adults and Children with Hypoplasminogenemia". The general objectives of this clinical study, (Protocol #2002C005G), are to determine the optimal dose and interval required to support the planned Phase 2/3 study and to investigate initial safety and tolerability.
Primary Outcome
The following PK parameters will be calculated from PLG activity and antigen levels using the non-compartmental PK analysis method: Area under the concentration time curve (both AUC0-t and AUC0-inf), maximum plasma concentration (Cmax), volume of distribution (Vd), clearance (Cl), and mean residence time (MRT). Pharmacokinetic (PK) profile of lyophilized plasminogen (PLG) at 3 dose levels (the third dose is optional) in subjects with hypoplasminogenemia to determine the desirable dose and dosing
Interventions
- BIOLOGICAL Plasminogen (Human) Intravenous
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2014-12 |
| Est. Completion | 2016-02 |
| Phase | Phase 1 |
What the finished NCT02312180 record still lists
NCT02312180 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which Plasminogen (Human) Intravenous is the first listed.
NCT02312180 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02312180 about?
NCT02312180 is a clinical study titled "A Phase 1 Study of ProMetic Plasminogen (Human) Intravenous in Adults and Children With Plasminogen Deficiency". ProMetic is intiitating a first-in-man study entitled "A Phase 1, Dose Escalation, and Pharmacokinetic Study of ProMetic Plasminogen Administered as Intravenous Infusion in Adults and Children with Hypoplasminogenemia". The general objectives of this clinical study, (Protocol #2002C005G), are to det...
What is the current status of trial NCT02312180?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2014-12. Estimated completion is 2016-02.
What interventions are being tested in trial NCT02312180?
The interventions under investigation include: Plasminogen (Human) Intravenous (BIOLOGICAL).
Who is sponsoring clinical trial NCT02312180?
This trial is sponsored by Prometic Biotherapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02312180's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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