Chronic Kidney Disease, Healthy Volunteers
Conditions
Brief summary
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.
Interventions
DRUGIGT-303
IGT-303 administered via IV or SC
DRUGPlacebo
Saline
Sponsors
Ingenia Therapeutics INC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant 18-75 years of age, inclusive, at Screening; * Able to understand the key components of the study as described in the written informed consent document, and willing and able to provide written informed consent; * Body mass index (BMI) within the range of 18.5 to 40 kg/m2 at Screening; * Have a diagnosis of chronic kidney disease stage 2-3b, resulting from Type 2 diabetic nephropathy; * UACR \>30 mg/g, \<5000 mg/g at Screening and Day -1; * If taking antihypertensive and/or antidiabetic medication, doses of medications must be stable for at least 90 days prior to Screening; * Participants assigned male at birth (AMAB) will be either sterile or agree to use an approved method of contraception from Screening until at least 5 half-lives plus 90 days after the last dose of study drug, or do not engage in sexual relations which carry a risk of pregnancy (does include abstinence), and agree to refrain from sperm donation and in vitro fertilization until 5 half-lives plus 90 days after the last dose of the study drug; Participants assigned female at birth (AFAB) must be of non-childbearing potential or agree to use two highly effective methods of conception from Screening until at least 5 half-lives plus 30 days after the last dose of study drug or do not engage in sexual relations which carry a risk of pregnancy (does include abstinence), and agree to refrain from egg donation and in vitro fertilization until 5 half-lives plus 30 days after the last dose of the study drug * In the opinion of the Investigator, is able to adhere to the requirements of the study, including required overnight stays in the research site; * For participants in Cohort 9 only, have a diagnosis of nonproliferative diabetic retinopathy
Exclusion criteria
* Known allergy to study medication or its components (non-medicinal ingredients) or a history of a severe allergic reaction to any drug or history of multiple food/drug allergies; * Use of cigarettes exceeding \>5 cigarettes per week at time of Screening; social/casual cigarette use (≤5 per week) is permitted during the study, but participants must be willing to abstain during inpatient confinement; * Positive urine screen for drugs of abuse including tetrahydrocannabinol or has a positive breathalyzer test, at Screening or at Day -1; * Any illness or medical history that would impact safety or compliance with study requirements or impact ability to interpret study data * For participants in Cohort 9 only, presence of diabetic macular edema with anti-vascular endothelial growth factor (VEGF) treatment or vitreous hemorrhage.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs) | From Screening to Day 84. | The number and severity (by Grade) will be measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK Parameters of Intravenous (IV) and Subcutaneous (SC) IGT-303 | Day 1 to Day 84. | Maximum observed concentration (Cmax) |
| PK Parameters of IV and SC IGT-303 | Day 1 to Day 84 | Observed time of maximum concentration (Tmax) |
| PK parameters of IV and SC IGT-303 | Day 1 to Day 84 | 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) |
Countries
Australia, New Zealand
Contacts
CONTACTJennifer Curry, PharmD
CONTACTJinsam You, PhD
PRINCIPAL_INVESTIGATOREmma Trowbridge, MD
Nucleus Network
Outcome results
None listed