Is NCT07231679 recruiting in Statesville, NC?

Yes, NCT07231679 is currently recruiting participants at its Statesville, NC location. This healthy volunteers clinical trial is actively enrolling qualified participants.

How do I join the healthy volunteers clinical trial in Statesville?

To join this clinical trial in Statesville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Statesville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Healthy Volunteers Clinical Trial in Statesville, NC

About This Healthy Volunteers Study in Statesville

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.

Sponsor: Ingenia Therapeutics INC

Who Can Participate

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;

If taking antihypertensive and/or antidiabetic medication, doses of medications must be stable for at least 90 days prior to Screening;

Stable eGFR. in the opinion of the Investigator, for at least 90 days prior to Screening;

HbA1C \<9.0% at 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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Statesville?

Yes, this clinical trial (NCT07231679) has an active research site in Statesville, NC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Healthy Volunteers Treatment Options in Statesville, NC

If you're searching for healthy volunteers treatment options in Statesville, NC, this clinical trial (NCT07231679) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Statesville research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced healthy volunteers specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Healthy Volunteers Clinical Trial in Statesville, NC

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