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Purpose

This study is a Phase 1b/2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-103. The approximately 208-day study consists of a Screening Period (28 days), Treatment Period (90 days), and Post-Dose Evaluations (90 days).

Conditions

Eligibility

Eligible Ages
Between 12 Years and 35 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Participants who are willing and able to provide Institutional Review Board (IRB) approved written informed consent and privacy language as per national regulations. 2. Men and non-pregnant, non-breast-feeding women ages 12-35 years inclusive. 3. Documented diagnosis of T1D within 180 days prior to study enrollment according to at least 1 of the American Diabetes Association [ADA] criteria. 4. Participants must be on standard of care diabetes management (e.g., insulin therapy, a nutrition plan, regular exercise, or other relevant specialty care). 5. Participants with a peak stimulated C-peptide of >0.2 nmol/L measured from a mixed meal tolerance test (MMTT). Note: this test result may be obtained from an MMTT conducted within 1 month of planned first dose. 6. Participants with an episode of diabetic ketoacidosis (DKA) must have a MMTT performed no sooner than 2 weeks and up to 4 weeks after resolution of the DKA event to have a qualifying C-peptide reading. 7. Participants on systemic corticosteroids or any medication used to treat the symptoms of T1D must undergo a washout period of at least two weeks prior to enrollment and must agree to use a non-steroid alternative throughout the trial, if necessary, for any disorder requiring corticosteroids. In addition, participants must be on a stable dose of any other medications, other than insulin, for a minimum of 1 month prior to enrollment and must agree not to increase their dose from the Screening Visit through the End of Study Visit unless reviewed and approved by the medical monitor and the principal investigator.

Exclusion Criteria

  1. Participants who have used the following medications: a. Within 5 half-lives or 90 days prior to first dose, whichever is shorter: - Oral immunomodulators (e.g., cyclosporin, azathioprine, methotrexate) - B cell depleting immunotherapy (e.g., Rituximab) 2. Other anti-diabetic agents besides insulin (e.g., Verapamil). 3. Within 6 months prior to first dose: a. T cell modifying immunotherapy (e.g., Abatacept, Etanercept, Ustekinumab) 4. Within 12 months prior to first dose: a. T cell depleting immunotherapy (e.g., Teplizumab) 5. Exclusion of additional immunomodulation will be at the discretion of the medical monitor and study site Investigator.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
The study will enroll up to three cohorts across two descending age groups, adults (18-35 years) and adolescents (12-17 years), with six subjects per cohort (approximately 18 subjects per age group, 36 subjects total) at multiple ascending dose levels during the Escalation Phase. Enrollment of each adolescent cohort will be staggered, beginning only after the corresponding adult cohort has completed the Day 15 visit and undergone DMC review. Subjects will be randomized 2:1 to receive either CNP-103 or placebo (0.9% Sodium Chloride Injection, USP) as a 200 mL intravenous infusion on Day 1, Day 8, and Day 90. The Expansion Phase will follow, enrolling approximately 36 subjects at the safe and tolerated dose(s) identified during the Escalation Phase. Subjects in this phase will be randomized 3:1 to receive either CNP-103 or placebo (0.9% Sodium Chloride Injection, USP).
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Adult Cohort 1 (100 mg CNP-103) 		Three (3) IV administrations of CNP-103 (100 mg) on Days 1, 8, and 90
  • Drug: CNP-103
    CNP-103
    Other names:
    • Treatment
  • Drug: Placebo
    0.9% sodium chloride for injection
Experimental
Adult Cohort 2 (300 mg CNP-103) 		Three (3) IV administrations of CNP-103 (300 mg) on Days 1, 8, and 90
  • Drug: CNP-103
    CNP-103
    Other names:
    • Treatment
  • Drug: Placebo
    0.9% sodium chloride for injection
Experimental
Adult Cohort 3 (600 mg CNP-103) 		Three (3) IV administrations of CNP-103 (600 mg) on Days 1, 8, and 90
  • Drug: CNP-103
    CNP-103
    Other names:
    • Treatment
  • Drug: Placebo
    0.9% sodium chloride for injection
Experimental
Adolescent Cohort 1 (100 mg CNP-103) 		Three (3) IV administrations of CNP-103 (100 mg) on Days 1, 8, and 90
  • Drug: CNP-103
    CNP-103
    Other names:
    • Treatment
  • Drug: Placebo
    0.9% sodium chloride for injection
Experimental
Adolescent Cohort 2 (300 mg CNP-103) 		Three (3) IV administrations of CNP-103 (300 mg) on Days 1, 8, and 90
  • Drug: CNP-103
    CNP-103
    Other names:
    • Treatment
  • Drug: Placebo
    0.9% sodium chloride for injection
Experimental
Adolescent Cohort 3 (600 mg CNP-103) 		Three (3) IV administrations of CNP-103 (600 mg) on Days 1, 8, and 90
  • Drug: CNP-103
    CNP-103
    Other names:
    • Treatment
  • Drug: Placebo
    0.9% sodium chloride for injection
Experimental
Expansion Cohort 		Dosing for the Expansion Cohort will be determined from Escalation Phase results
  • Drug: CNP-103
    CNP-103
    Other names:
    • Treatment
  • Drug: Placebo
    0.9% sodium chloride for injection

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University School of Medicine
St Louis, Missouri 63110
Contact:
Elizabeth Sellitto
314-362-6821
esellitto@wustl.edu

More Details

NCT ID
NCT06783309
Status
Recruiting
Sponsor
COUR Pharmaceutical Development Company, Inc.

Study Contact

Stephanie Slaughter
317-727-2551
sslaughter@courpharma.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.