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

COUR Pharmaceuticals

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Type 1 Diabetes Patients; Type 1 Diabetes Mellitus; Type 1 Diabetes; T1D; Type 1 Diabetes in Adolescence; T1DM; Type 1 Diabetes in Children; Type 1 Diabetes (Juvenile Onset); Type 1 Diabetes Mellitis; T1DM - Type 1 Diabetes Mellitus

Treatments: Drug: CNP-103; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06783309

CNP-103-CL-201

Details and patient eligibility

About

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).

Enrollment: 72 estimated patients

Sex: All

Ages: 12 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 7 patient groups

Adult Cohort 1 (100 mg CNP-103)

Experimental group

Description:

3 separate administrations of 100 mg IV CNP-103 at Days 1, 8, and 90

Treatment:

Drug: Placebo

Drug: CNP-103

Adult Cohort 2 (300 mg CNP-103)

Experimental group

Description:

3 separate administrations of 300 mg IV CNP-103 at Days 1, 8, and 90

Treatment:

Drug: Placebo

Drug: CNP-103

Adult Cohort 3 (600 mg CNP-103)

Experimental group

Description:

3 separate administrations of 600 mg IV CNP-103 at Days 1, 8, and 90

Treatment:

Drug: Placebo

Drug: CNP-103

Adolescent Cohort 1 (100 mg CNP-103)

Experimental group

Description:

3 separate administrations of 100 mg IV CNP-103 at Days 1, 8, and 90

Treatment:

Drug: Placebo

Drug: CNP-103

Adolescent Cohort 2 (300 mg CNP-103)

Experimental group

Description:

3 separate administrations of 300 mg IV CNP-103 at Days 1, 8, and 90

Treatment:

Drug: Placebo

Drug: CNP-103

Adolescent Cohort 3 (600 mg CNP-103)

Experimental group

Description:

3 separate administrations of 600 mg IV CNP-103 at Days 1, 8, and 90

Treatment:

Drug: Placebo

Drug: CNP-103

Expansion Cohort

Experimental group

Treatment:

Drug: Placebo

Drug: CNP-103