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This will be a single center, open-label study in healthy male subjects between 18 and 45 years old to determine the dose response profiles of dermal blood flow in response to intradermal injections of maxadilan. The study will consist of 2 parts: Part I: dose and time finding and Part II: reproducibility over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Intradermal injection of maxadilan solution |
|
| Placebo | Placebo Comparator | Intradermal injection of placebo (=vehicle) solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maxadilan | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in dermal blood flow induced by intradermal injections of maxadilan, compared to baseline and placebo for different doses, time point and in terms of reproducibility over time (i.e. inter-period reproducibility). | Every studyvisit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II) | |
| Changes in vital signs. | as a measure of safety | Every studyvisit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II) and at 5-7 days after last studyvisit (post-study visit) |
| Changes in ECG. | as a measure of safety | Every studyvisit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II) and at at 5-7 days after last studyvisit (post-study visit) |
| Change in laboratory safety tests. | as a measure of safety | Every studyvisit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II) and at at 5-7 days after last studyvisit (post-study visit) |
| Change in physical examination. | as a measure of safety | Every studyvisit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II) and at at 5-7 days after last studyvisit (post-study visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of intradermal injections of maxadilan in healthy male subjects. Assessed using the Numerical rating scale-11 for pain. | Assessed using the Numerical rating scale-11 for pain. | Every study visit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II) and at at 5-7 days after last studyvisit (post-study visit) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Clinical Pharmacology, UZ Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
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| ID | Term |
|---|---|
| C069147 | maxadilan protein, insect |
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|
| Change in dermal blood flow induced by intradermal injections of maxadilan, compared to baseline and placebo in terms of reproducibility between arms (i.e. inter-arm reproducibility. |
| Every studyvisit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II) |