StrokePhase 1NCT02868996
An Open Label, Phase 1b, Ascending Dose Study of DM199
A Phase 1 study testing Recombinant human tissue kallikrein in people with Stroke, run by DiaMedica Therapeutics Inc at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Recombinant human tissue kallikrein
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteAustralia
- Study dates
- Sep 2016to Mar 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- Females who are pregnant or nursing;
- Females of childbearing potential (i.e., any woman who is not surgically sterile e.g., hysterectomy, bilateral oophorectomy or >1-year postmenopause status confirmed by follicle-stimulating hormone (FSH) levels as defined by established lab ranges) and all men who, if participating in heterosexual sexual activity that could lead to pregnancy are unable or unwilling to practice medically effective contraception during the study. They should agree to use two reliable methods of contraception (e.g., double-barrier condom plus diaphragm, condom or diaphragm plus a stable dose of hormonal contraception) throughout the study period and until 3 months after receiving study drug. Women of childbearing potential will require compulsory pregnancy testing. A negative pregnancy test (serum and urine) will be documented during screening and at Day -1 respectively;
- Participation in any other drug study within 8 weeks or 5 half-lives of the study drug, whichever is longer;
- Unable or unwilling to comply with the protocol requirements for study visits and procedures;
- Subjects who do not have good venous access for infusion of study drug or for blood sampling;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Stroke
- Being tested
- Recombinant human tissue kallikrein
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human tissue kallikreinDrug
Also called DM199
Intravenous DM199
| Study group | Role | What they receive |
|---|---|---|
| Low dose (Part A) | Experimental | Recombinant human tissue kallikrein Receives: Drug: Recombinant human tissue kallikrein |
| Medium low dose (Part A) | Experimental | Recombinant human tissue kallikrein Receives: Drug: Recombinant human tissue kallikrein |
| Medium high dose (Part A) | Experimental | Recombinant human tissue kallikrein Receives: Drug: Recombinant human tissue kallikrein |
| High dose (Part A) | Experimental | Recombinant human tissue kallikrein Receives: Drug: Recombinant human tissue kallikrein |
| Subcutaneous (Part B) | Experimental | Recombinant human tissue kallikrein Receives: Drug: Recombinant human tissue kallikrein |
| IV (Part B) | Experimental | Recombinant human tissue kallikrein Receives: Drug: Recombinant human tissue kallikrein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Assessment of safety of intravenous dosing
Measured: 30 days
Secondary outcomes (2)
Concentration of DM199 in plasma
Assess plasma drug levels
Measured: 3 days
Concentration of bradykinin in plasma
Assess drug associated biomarkers (e.g. plasma bradykinin levels)
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- DiaMedica Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868996
- Sponsor's protocol ID
- DM199-2016-001
- Status last verified
- Dec 2017
- First submitted
- 8 Aug 2016
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02868996
- Acronym / sponsor ID
- DM199-2016-001
- Conditions
- Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- DiaMedica Therapeutics IncIndustry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- Sep 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Low dose (Part A) | Experimental | Drug: Recombinant human tissue kallikreinRecombinant human tissue kallikrein |
| Medium low dose (Part A) | Experimental | Drug: Recombinant human tissue kallikreinRecombinant human tissue kallikrein |
| Medium high dose (Part A) | Experimental | Drug: Recombinant human tissue kallikreinRecombinant human tissue kallikrein |
| High dose (Part A) | Experimental | Drug: Recombinant human tissue kallikreinRecombinant human tissue kallikrein |
| Subcutaneous (Part B) | Experimental | Drug: Recombinant human tissue kallikreinRecombinant human tissue kallikrein |
| IV (Part B) | Experimental | Drug: Recombinant human tissue kallikreinRecombinant human tissue kallikrein |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant human tissue kallikreinAlso: DM199Intravenous DM199 | Drug | High dose (Part A), IV (Part B), Low dose (Part A), Medium high dose (Part A), Medium low dose (Part A), Subcutaneous (Part B) |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 30 days
Assessment of safety of intravenous dosing
2 secondary outcomes
Concentration of DM199 in plasma
Time frame: 3 days
Concentration of bradykinin in plasma
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
- Safety, tolerability and pharmacokinetic profile of recombinant human tissue kallikrein, DM199, after intravenous and subcutaneous administration in healthy volunteersLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant human tissue kallikrein in people with Stroke, run by DiaMedica Therapeutics Inc at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2017.