A Study to Investigate IGT-303 in Healthy Volunteers and Participants With Chronic Kidney Disease
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorIngenia Therapeutics INC
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
IGT-303
DrugIGT-303 administered via IV or SC
Placebo
DrugSaline
Treatment groups
94 Participants
are divided into 2 treatment groupsGroup A: IGT-303Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs)
The number and severity (by Grade) will be measured.
Time frame
From Screening to Day 84.Secondary outcomes
1
PK Parameters of Intravenous (IV) and Subcutaneous (SC) IGT-303
Maximum observed concentration (Cmax)
Time frame
Day 1 to Day 84.2
PK Parameters of IV and SC IGT-303
Observed time of maximum concentration (Tmax)
Time frame
Day 1 to Day 843
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)
Time frame
Day 1 to Day 844
PK Parameters of IV and SC IGT-303
Terminal exponential half-life, calculated as ln(2)/λz (T1/2)
Time frame
Day 1 to Day 84Sponsors and contacts
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Source ClinicalTrials.gov