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The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of QHRD106 early in Chinese healthy subjects with single doses.
Eight dose groups were initially set up. The experimental groups were increased from low to high dose according to the principle of increasing dose, and Placebo was added as the control group. All the selected subjects in the experimental group were given the drug once.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part-A SAD in healthy subjects(Cohort 1-8) | Experimental | A randomized, double-blinded, placebo-controlled, single ascending dose (SAD) study in healthy male and female subjects. Subjects will receive QHRD106 by intramuscular-injection (im). |
|
| Part-B Healthy subjects SAD placebo | Experimental | A randomized, double-blinded, placebo-controlled, single ascending dose (SAD) study in healthy male and female subjects. Subjects will receive placebo by intramuscular-injection (im). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QHRD106 Injection | Drug | 250IU~8400IU,pegylated(PEG)-tissue kallikrein-1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety as assessed by incidence, severity, and causality of adverse events | The frequency and number of adverse events, adverse reactions and serious adverse | Up to 36 days after final dose |
| Plasma measurements of QHRD106 | The concentration of a single dose was measured at 8 different doses | Up to 36 days after final dose |
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Inclusion Criteria:
Exclusion Criteria:
Subjects who meet one of the following conditions will not be enrolled in the trial:
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| Name | Affiliation | Role |
|---|---|---|
| Juan Li, Doctor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Drum Tower Hospital | Nanjing | Jiangsu | 210008 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39545461 | Derived | Huang L, Sun R, Song H, Chen Z, Hong Y, Yang H, Zhang Y, Wei L, Fei F, Li J. The first-in-human study of QHRD106 functioning as a safe and effective long-acting kallikrein drug potentially aiding ischemic stroke. Expert Opin Investig Drugs. 2024 Dec;33(12):1257-1265. doi: 10.1080/13543784.2024.2430200. Epub 2024 Nov 19. |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| placebo | Drug | placebo |
|
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |