Hypoplasminogenemia Clinical Trial
Official title:
A Phase 1, Dose Escalation, and Pharmacokinetic Study of ProMetic Plasminogen Administered as Intravenous Infusion in Adults and Children With Hypoplasminogenemia
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.
The Phase 1 study will be a single center study, the subjects will be from across country. It
is an open-label, single-arm, dose-escalation study in patients with hypoplasminogenemia aged
12 years and older.
Three dose cohorts are planned to achieve a target sample size of 12 evaluable subjects. This
will ensure a minimum of 4 evaluable subjects in each cohort. Due to the challenges of
patient availability and burden of cross country travel, each cohort will enroll no more than
6 subjects. Any subject may participate in multiple cohorts, as judged appropriate by the
investigator.
In each cohort, each subject must be diagnosed with hypoplasminogenimia and have a
plasminogen activity level of ≤ 40% before they will be administered a single dose of
Plasminogen (Human), the investigational medicinal product. Plasminogen will be administered
as an intravenous (IV) infusion at the following doses:
- Cohort 1: 2 mg/kg
- Cohort 2: 6 mg/kg
- Cohort 3*: 12 mg/kg * Optional. If optimal dosing information is demonstrated in either
Cohort 1 or 2, Cohort 3 will not be pursued.
At each dose level, Plasma plasminogen activity and antigen levels will be measured to
develop a pharmacokinetic profile. Blood samples will be drawn at the following time points:
baseline immediately before dosing; at the end of infusion; and at 1, 6, 24, 48, 72, 96, 120,
168, and 216 hours after the end of infusion. Visits 1-4 and 11 must be conducted at the
clinical site. A subject may conduct Visits 5-10 at the clinical site or have the study
procedures performed by a Home Health Nurses Group (HHNG) nurse through home visits, if
continued visits to the study site are not possible or practical.
Subjects will have another visit 14 days after the IV infusion for Visit 10 (Day 15,
Short-term-Safety Visit). Subjects will return to the clinic 30 days after IV infusion for
Visit 11 (Day 30, Follow-up-Safety Visit) for the collection of adverse events (AEs),
immunogenicity testing, routine safety tests and procedures, and final viral safety testing,
unless the subject is entering into another Cohort.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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|
Phase 2/Phase 3 | |
| No longer available |
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||
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