RECRUITING

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

Description

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).

Study Overview

Study Details

Study overview

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).

A Phase 1b/2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-103 in Subjects Ages 12-35 With Recent Onset Stage 3 Type 1 Diabetes

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

Condition
Type 1 Diabetes Mellitus
Intervention / Treatment

-

Contacts and Locations

Walnut Creek

Diablo Clinical Research, Walnut Creek, California, United States, 94598

Aurora

Barbara Davis Center for Childhood Diabetes, Aurora, Colorado, United States, 80045

Miami

DY Professional Research Center, Miami, Florida, United States, 33176

Baltimore

Barry J. Reiner, MD, LLC, Baltimore, Maryland, United States, 21229

Syosset

MainStreet Health, Syosset, New York, United States, 11566

Raleigh

Wake Research, Raleigh, North Carolina, United States, 27616

Smithfield

Superior Clinical Research, Smithfield, North Carolina, United States, 27277

Austin

Texas Diabetes & Endocrinology, Austin, Texas, United States, 78749

Dallas

M3 Wake Research - Dallas, Dallas, Texas, United States, 75224

Denton

Revival Research Institute, Denton, Texas, United States, 76210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 4. 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.
  • 5. 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
  • * Subjects who have used the following medications:
  • 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.

Ages Eligible for Study

12 Years to 35 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

COUR Pharmaceutical Development Company, Inc.,

Paul Peloso, MD, STUDY_DIRECTOR, COUR Pharma

Study Record Dates

2027-06