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The goal of this clinical trial is to observe the safety of IGT-303 in healthy volunteers and participants with Chronic Kidney Disease. The main question it aims to answer is:
Is IGT-303 safe as a single dose or multiple dose regimen when applied under the skin (subcutaneously (SC)) or to a vein (intravenously (IV)).
Researchers will compare IGT-303 against a placebo to see if IGT-303 is safe for use.
Participants will be assigned to either IGT-303 or placebo and assessed for safety and tolerability for the duration of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IGT-303 | Experimental | Part A: single ascending dose (SAD), 6 cohorts Part B: multiple ascending dose (MAD), 3 cohorts |
|
| Placebo | Placebo Comparator | Placebo (normal saline) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IGT-303 | Drug | IGT-303 administered via IV or SC |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs) | The number and severity (by Grade) will be measured. | From Screening to Day 84. |
| Measure | Description | Time Frame |
|---|---|---|
| PK Parameters of Intravenous (IV) and Subcutaneous (SC) IGT-303 | Maximum observed concentration (Cmax) | Day 1 to Day 84. |
| PK Parameters of IV and SC IGT-303 | Observed time of maximum concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Curry, PharmD | Contact | 317-726-9118 | jc@curryclinicalconsulting.com | |
| Jinsam You, PhD | Contact | 617-440-2518 | jyou@ingeniatx.com |
| Name | Affiliation | Role |
|---|---|---|
| Emma Trowbridge, MD | Nucleus Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network | Recruiting | Herston | Brisbane | 4006 | Australia | |
| University of Sunshine Coast-Morayfield |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Drug |
Saline |
|
| Day 1 to Day 84 |
| PK Parameters of IV and SC IGT-303 | Terminal exponential rate constant, determined using the linear least squares regression of the terminal phase of the log-serum concentration time profile (λz) | Day 1 to Day 84 |
| PK Parameters of IV and SC IGT-303 | Terminal exponential half-life, calculated as ln(2)/λz (T1/2) | Day 1 to Day 84 |
| PK parameters of IV and SC IGT-303 | Area under the concentration-time curve calculated using linear trapezoidal rule from time zero to time t, where t is the time of the last observed quantifiable concentration (AUC0-t) | Day 1 to Day 84 |
| PK parameters of IV and SC IGT-303 | Area under the concentration-time curve from time zero to infinity, defined as AUC0-t + Ct/λz (AUC0-∞) | Day 1 to Day 84 |
| PK parameters of IV and SC IGT-303 | Total clearance (CL), defined as dose/AUC0-∞ | Day 1 to Day 84 |
| PK parameters of IV and SC IGT-303 | Terminal volume of distribution (Vz), defined as CL/λz | Day 1 to Day 84 |
| PK parameters of IV and SC IGT-303 | Absolute bioavailability (F), defined as the dose-corrected (AUC0-∞ SC) / (AUC0-∞ IV) | Day 1 to Day 84 |
| Recruiting |
| Morayfield |
| Queensland |
| 4506 |
| Australia |
| University of the Sunshine Coast Clinical Trials-Southbank | Recruiting | Morayfield | Queensland | 4506 | Australia |
| Pacific Clinical Research Network | Recruiting | Takapuna | Auckland | 0622 | New Zealand |
| Momentum Clinical Research | Recruiting | Waikanae Beach | Kapiti Coast | 5036 | New Zealand |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |