An Open Label, Phase 1b, Single CENTER, Ascending Dose Study TO ASSESS THE SAFETY AND TOLERABILITY of DM199 With a Comparative Pharmacokinetic Study of DM199 Administered Intravenously and a Bioavailability Assessment of Subcutaneous Administration of DM199 in Normal Healthy Subjects

DiaMedica Therapeutics Inc1 site in 1 country36 target enrollmentSeptember 2016

ConditionsStroke

InterventionsRecombinant human tissue kallikrein

DrugsRecombinant human tissue kallikrein

Overview

Phase: Phase 1
Intervention: Recombinant human tissue kallikrein
Conditions: Stroke
Sponsor: DiaMedica Therapeutics Inc
Enrollment: 36
Locations: 1
Primary Endpoint: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase 1B study to assess the safety, tolerability and pharmacokinetics of DM199 in healthy volunteers. The study will be consist of two parts: Part A will focus on intravenous dosing and Part B will directly compare intravenous dosing with subcutaneous dosing.

Registry

clinicaltrials.gov

Start Date

September 2016

End Date

March 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

DiaMedica Therapeutics Inc

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female between 18 and 50 years of age (inclusive);
•Healthy with no clinically significant medical problems;
•BMI between 18 to 30 kg/m2 with a weight between 50 to 100 kg (both inclusive);
•No history of alcohol or drug abuse (Paracetamol, Barbiturates, Benzodiazepines, Cocaine, Methadone, Amphetamines, Methamphetamines, Opiates, Phencyclidine, Tetrahydrocannabinol (cannabis), Tricyclic Antidepressants). Subjects should be enrolled only after passing the urine drug screen (positive test for paracetamol will be allowed);
•Non-smokers or light smokers (Less than 5 cigarettes per day) by history and planned during the study;
•No history of significant allergic diathesis such as urticaria, angioedema or anaphylaxis;
•Receiving no chronic medications that affect blood pressure control, the bradykinin or angiotensin system including angiotensin-converting-enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB);
•Willing and able to sign written, informed consent.

Exclusion Criteria

•Any significant past or current cardiac, pulmonary, hepatic, renal or other medical condition which in the opinion of the investigator would make participation of the subject in this study medically unsafe or compromise the accuracy of assessment of safety, pharmacokinetic and pharmacodynamic data of the study;
•Subjects who have abnormal safety labs outside the local lab ranges will be excluded at PI's discretion based on his/her assessment of clinical significance (can be repeated once at screening at PI's discretion);
•Subjects with past medical history of malignancy except basal cell or squamous cell carcinoma of the skin who have had curative surgical treatment and at least 6 months have elapsed since the procedure;
•A value outside the specified range of 90 mm Hg - 140 mm Hg for systolic blood pressure and 50 mm Hg - 90 mm Hg for diastolic blood pressure (both inclusive) at screening (can be repeated once at screening as per PI's discretion);
•Subjects using angiotensin-converting-enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB) to control blood pressure;
•History of clinically significant acute bacterial, viral, or fungal systemic infections in the last 4 weeks prior to screening;
•Clinical or laboratory evidence of an active infection at the time of screening;
•Known alpha 1-antitrypsin deficiency (α1-antitrypsin deficiency);
•Serological evidence of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (Anti-HCV) at screening;
•Vaccination within 3 months of screening for the study or requiring vaccination during the study or within 3 months after completion of the study;