CNP-103 in Adolescent and Adult Subjects Ages 12-35 With Recently Diagnosed (Within 6 Months) Stage 3 Type 1 Diabetes (T1D)

Phase 1

Recruiting

• Conditions: Type 1 Diabetes Mellitus; T1D; T1DM; T1DM - Type 1 Diabetes Mellitus; Type 1 Diabetes in Adolescence; Type 1 Diabetes in Children; Type 1 Diabetes (Juvenile Onset); Type 1 Diabetes; Type 1 Diabetes Patients; Type 1 Diabetes Mellitis
• Interventions: Drug: CNP-103; Drug: Placebo

• Registration Number: NCT06783309
• Lead Sponsor: COUR Pharmaceutical Development Company, Inc.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-14
• Study First Posted: 2025-01-20
• Study Start: 2025-05-12
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-17
• Last Update Posted: 2025-07-22
• Primary Completion: 2026-12
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• 1. Subjects 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 American Diabetes Association [ADA] criteria.

  3. Subjects 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.

  4. For subjects on any medication used to treat the symptoms of T1D (e.g., corticosteroids), subjects must be on a stable dose for a minimum of 1 month prior to enrollment and must agree not to increase their dose from Screening Visit through End of Study Visit unless reviewed and approved by the medical monitor and the site investigator

Exclusion Criteria

• Subjects who have used the following medications:

  a. Within 5 half-lives or 90 days prior to first dose, whichever is shorter: i. Oral immunomodulators: (i.e., cyclosporin, azathioprine, methotrexate) ii. B cell depleting immunotherapy (e.g., Rituximab) iii. Other anti-diabetic agents besides insulin (e.g., Verapamil). Insulin is allowed if on a stable dose for 30 days prior to the Day 1 dose). b. Within 6 months prior to first dose: i. T cell modifying immunotherapy (e.g., Abatacept, Etanercept, Ustekinumab) within 6 months prior to the first dose c. Within 12 months prior to first dose: i. T cell depleting immunotherapy (e.g., Teplizumab) within 12 months prior to the first dose d. Exclusion of additional immunomodulation will be at the discretion of the medical monitor and study site Investigator.

  2. Subjects who present with diabetic ketoacidosis (DKA) at the time of diagnosis. Note: any MMTT must be performed no sooner than 2 weeks and up to 4 weeks after DKA diagnosis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adult Cohort 1 (100 mg CNP-103)	CNP-103	3 separate administrations of 100 mg IV CNP-103 at Days 1, 8, and 90
Adult Cohort 1 (100 mg CNP-103)	Placebo	3 separate administrations of 100 mg IV CNP-103 at Days 1, 8, and 90
Adult Cohort 2 (300 mg CNP-103)	CNP-103	3 separate administrations of 300 mg IV CNP-103 at Days 1, 8, and 90
Adult Cohort 2 (300 mg CNP-103)	Placebo	3 separate administrations of 300 mg IV CNP-103 at Days 1, 8, and 90
Adult Cohort 3 (600 mg CNP-103)	Placebo	3 separate administrations of 600 mg IV CNP-103 at Days 1, 8, and 90
Adolescent Cohort 1 (100 mg CNP-103)	Placebo	3 separate administrations of 100 mg IV CNP-103 at Days 1, 8, and 90
Adolescent Cohort 2 (300 mg CNP-103)	Placebo	3 separate administrations of 300 mg IV CNP-103 at Days 1, 8, and 90
Adolescent Cohort 3 (600 mg CNP-103)	Placebo	3 separate administrations of 600 mg IV CNP-103 at Days 1, 8, and 90
Expansion Cohort	Placebo	-
Adolescent Cohort 1 (100 mg CNP-103)	CNP-103	3 separate administrations of 100 mg IV CNP-103 at Days 1, 8, and 90
Adolescent Cohort 2 (300 mg CNP-103)	CNP-103	3 separate administrations of 300 mg IV CNP-103 at Days 1, 8, and 90
Adolescent Cohort 3 (600 mg CNP-103)	CNP-103	3 separate administrations of 600 mg IV CNP-103 at Days 1, 8, and 90
Expansion Cohort	CNP-103	-
Adult Cohort 3 (600 mg CNP-103)	CNP-103	3 separate administrations of 600 mg IV CNP-103 at Days 1, 8, and 90

Primary Outcome Measures

Name	Time	Method
Safety	Day 1 Through Day 180	Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs), MedDRA 23.0 (CTCAE v. 5.0) or current
Immune Safety	Day 1 Through Day 180	Serum Cytokines: IL-1β, TNF-α, IL-6, MCP-1, MIP-1α, IFN-γ, IL-4, IL-10

Trial Locations

Locations (13)

Diablo Clinical Research; 🇺🇸 Walnut Creek, California, United States

Barbara Davis Center for Childhood Diabetes; 🇺🇸 Aurora, Colorado, United States

DY Professional Research Center; 🇺🇸 Miami, Florida, United States

Barry J. Reiner, MD, LLC; 🇺🇸 Baltimore, Maryland, United States

MainStreet Health; 🇺🇸 Syosset, New York, United States

Wake Research; 🇺🇸 Raleigh, North Carolina, United States

Superior Clinical Research; 🇺🇸 Smithfield, North Carolina, United States

Texas Diabetes & Endocrinology; 🇺🇸 Austin, Texas, United States

M3 Wake Research - Dallas; 🇺🇸 Dallas, Texas, United States

Revival Research Institute; 🇺🇸 Denton, Texas, United States

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