Evaluation to Assess Safety and Tolerability of DM199 in Subjects With Acute Ischemic Stroke (ReMEDy1)

DiaMedica Therapeutics

Status and phase: Completed; Phase 2

Conditions: Acute Ischemic Stroke

Treatments: Drug: Recombinant human tissue kallikrein; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03290560

DM199-2017-001

Details and patient eligibility

About

This is a Phase II study to assess the safety and tolerability of DM199 in acute ischemic stroke patients. The study will be randomized, placebo controlled at multiple centers.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is >/= 18 years of age
2. Subject has been diagnosed with acute ischemic stroke with onset ≤ 24 hours from enrollment.
3. Subject has NIH stroke score (NIHSS) ≥ 6 and ≤ 25.
4. Subject or legally authorized representative is willing and able to sign written informed consent.

Exclusion criteria

1. Subject is currently prescribed angiotensin-converting-enzyme inhibitors (ACEi) and is unable or unwilling to convert to another antihypertensive pharmacological treatment during the active treatment period (+5 days) of the study.
2. Subject has a history of significant allergic diathesis such as urticaria, angioedema or anaphylaxis.
3. Subjects with current malignancy or active malignancy ≤ 3 years prior to enrollment except basal cell or squamous cell carcinoma of the skin or in situ cervical cancer that has undergone potentially curative therapy and at least six months have elapsed since the procedure.
4. Subject has a history of clinically significant acute bacterial, viral, or fungal systemic infections in the last four weeks prior to enrollment.
5. Subject has clinical or laboratory evidence of an active infection at the time of enrollment.
6. Subject has known alpha 1-antitrypsin deficiency (α1-antitrypsin deficiency).
7. Subject has a known diagnosis of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (Anti-HCV) at screening.
8. Subject is pregnant or nursing.
9. Subject is male or female of childbearing potential, is participating in heterosexual sexual activity that could lead to pregnancy, and is unable or unwilling to practice medically effective contraception during the study.
10. Subject is participating in any other investigational device or other drug study ≤ 4 weeks or 5 half-lives of the investigational product, whichever is longer.
11. Subject does not have sufficient venous access for infusion of study treatment or blood sampling.
12. In the opinion of the Investigator, subject is unlikely to be followed for the duration of t the study.
13. Subject is unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits.
14. Subject has any other medical condition which in the opinion of the Investigator will make participation medically unsafe or interfere with the study results.
15. Pre-stroke Modified Rankin Scale ≥4

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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92 participants in 2 patient groups, including a placebo group

Recombinant human tissue kallikrein

Experimental group

Description:

A single IV infusion of 1 microgram/kg followed by 8 subcutaneous injections of 3 microgram/kg occurring every 72 hours.

Treatment:

Drug: Recombinant human tissue kallikrein

Placebo

Placebo Comparator group

Description:

A single IV infusion of 1 microgram/kg followed by 8 subcutaneous injections of 3 microgram/kg occurring every 72 hours.

Treatment:

Other: Placebo