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| ID | Type | Description | Link |
|---|---|---|---|
| BW-00163-1002 | Other Identifier | Argo Biopharma |
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This is a randomized, double-blind, placebo-controlled study including Part A single ascending dose (SAD) in healthy subjects and Part B single dose in subjects with mild hypertension.
Phase 1, multicenter, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of QCZ484. In Part A, single ascending doses of QCZ484 are tested in healthy subjects, while in Part B, single doses of QCZ484 are tested in subjects with mild hypertension. One dose of QCZ484 is administered subcutaneously.
This study was started by Argo Biopharma, and global sponsorship was transferred to Novartis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: QCZ484 50 mg | Experimental | Healthy Cohort: single dose |
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| Part A: QCZ484 150 mg | Experimental | Healthy Cohort: single dose |
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| Part A: QCZ484 300 mg | Experimental | Healthy Cohort: single dose |
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| Part A: QCZ484 600 mg | Experimental | Healthy Cohort: single dose |
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| Part A: QCZ484 Placebo | Placebo Comparator | Healthy Cohort: single dose |
|
| Part B: QCZ484 150 mg | Experimental | Hypertension Cohort: single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QCZ484 | Drug | doses of 50, 150, 300 or 600 mg via subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events (AEs) | Overall number of AEs, severity, and relationship to study treatment per treatment group. | Part A: up to 12 weeks post dose. Part B: up to 8 weeks post dose. |
| Number of participants with abnormalities in any laboratory parameter | Safety laboratory data (blood chemistry, hematology, coagulation, and urinalysis) | Part A: up to 12 weeks post dose. Part B: up to 8 weeks post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of AEs | Overall number of AEs, severity and relationship to study treatment per treatment group | up to 48 weeks post dose |
| Number of participants with abnormalities in any laboratory parameter |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Herston | Queensland | 4006 | Australia | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on www.novctrd.com | View source |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Part B: QCZ484 300 mg |
| Experimental |
Hypertension Cohort: single dose |
|
| Part B: QCZ484 600 mg | Experimental | Hypertension Cohort: single dose |
|
| Part B: QCZ484 Placebo | Placebo Comparator | Hypertension Cohort: single dose |
|
| Placebo | Drug | via subcutaneous injection |
|
Safety laboratory data (blood chemistry, hematology, coagulation, and urinalysis)
| up to 48 weeks post dose |
| Plasma pharmacokinetics of QCZ484 and metabolites - Cmax | Measured by Cmax - The maximum plasma concentration of QCZ484 and of potential metabolites | Day 1; up to Day 8 |
| Plasma pharmacokinetics of QCZ484 - Tmax | Measured by Tmax - Time to Reach the Maximum Concentration After Drug Administration of QCZ484 | Day 1; up to Day 8 |
| Plasma pharmacokinetics of QCZ484 and metabolites - AUC0-48 | Measured by AUC - Area under the curve versus time curve of QCZ484 from 0 to 48 hours (AUC0-48) and of potential metabolites | Day 1; up to Day 8 |
| Plasma pharmacokinetics of QCZ484 - AUC0-inf | Measured by AUC - Area under the curve versus time curve of QCZ484 from 0 to infinity (AUC0-inf) | Day 1; up to Day 8 |
| Plasma pharmacokinetics of QCZ484 - T1/2 | Measured by T1/2 - The elimination half-life of QCZ484 | Day 1; up to Day 8 |
| Urine pharmacokinetics of QCZ484 | Measured by urine concentration of QCZ484 up to 24 hours post dose | Day 1; up to Day 2 |
| Change from baseline in serum angiotensinogen (AGT) level | Measured by serum AGT level | up to 48 weeks post dose |
| Morayfield |
| Queensland |
| 4506 |
| Australia |
| Novartis Investigative Site | Adelaide | 5000 | Australia |
| Novartis Investigative Site | Auckland | 0622 | New Zealand |