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

NCT06783309 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CNP-103-CL-201
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 28

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 393-days study consists of a Screening Period (28 days), Treatment Period (90 days), and Post-Dose Evaluations (275 days).

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

Keywords

Diabetes; T1D; Stage 3; Adolescents; Adults; T1DM; Newly Diagnosed; Recently Diagnosed

Outcome Measures

Primary Outcomes (2)

• Safety

  Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs), MedDRA 28.1 (CTCAE v. 5.0) or current

  Day 1 Through Day 365

• Immune Safety

  Serum Cytokines: IL-1β, TNF-α, IL-6, MCP-1, MIP-1α, IFN-γ, IL-4, IL-10

  Day 1 Through Day 365

Study Arms (7)

Adult Cohort 1 (100 mg CNP-103)

EXPERIMENTAL

Three (3) IV administrations of CNP-103 (100 mg) on Days 1, 8, and 90

Drug: CNP-103; Drug: Placebo

Adult Cohort 2 (300 mg CNP-103)

EXPERIMENTAL

Three (3) IV administrations of CNP-103 (300 mg) on Days 1, 8, and 90

Drug: CNP-103; Drug: Placebo

Adult Cohort 3 (600 mg CNP-103)

EXPERIMENTAL

Three (3) IV administrations of CNP-103 (600 mg) on Days 1, 8, and 90

Drug: CNP-103; Drug: Placebo

Adolescent Cohort 1 (100 mg CNP-103)

EXPERIMENTAL

Three (3) IV administrations of CNP-103 (100 mg) on Days 1, 8, and 90

Drug: CNP-103; Drug: Placebo

Adolescent Cohort 2 (300 mg CNP-103)

EXPERIMENTAL

Three (3) IV administrations of CNP-103 (300 mg) on Days 1, 8, and 90

Drug: CNP-103; Drug: Placebo

Adolescent Cohort 3 (600 mg CNP-103)

EXPERIMENTAL

Three (3) IV administrations of CNP-103 (600 mg) on Days 1, 8, and 90

Drug: CNP-103; Drug: Placebo

Expansion Cohort

EXPERIMENTAL

Dosing for the Expansion Cohort will be determined from Escalation Phase results

Drug: CNP-103; Drug: Placebo

Interventions

CNP-103 DRUG

CNP-103

Also known as: Treatment

Adolescent Cohort 1 (100 mg CNP-103); Adolescent Cohort 2 (300 mg CNP-103); Adolescent Cohort 3 (600 mg CNP-103); Adult Cohort 1 (100 mg CNP-103); Adult Cohort 2 (300 mg CNP-103); Adult Cohort 3 (600 mg CNP-103); Expansion Cohort

Placebo DRUG

0.9% sodium chloride for injection

Adolescent Cohort 1 (100 mg CNP-103); Adolescent Cohort 2 (300 mg CNP-103); Adolescent Cohort 3 (600 mg CNP-103); Adult Cohort 1 (100 mg CNP-103); Adult Cohort 2 (300 mg CNP-103); Adult Cohort 3 (600 mg CNP-103); Expansion Cohort

Eligibility Criteria

• Age: 12 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants who are willing and able to provide Institutional Review Board (IRB) approved written informed consent and privacy language as per national regulations.
• Men and non-pregnant, non-breast-feeding women ages 12-35 years inclusive.
• Documented diagnosis of Stage 3 T1D within 180 days prior to study enrollment according to American Diabetes Association (ADA) criteria.
• Participants must be on standard of care diabetes management including insulin therapy as a routine and also consisting of a nutrition plan, regular exercise, or other relevant specialty care as required on a patient-by-patient basis.
• Participants with a peak stimulated C-peptide of \>0.2 nmol/L measured from a screening mixed meal tolerance test (MMTT).
• Participants with an episode of diabetic ketoacidosis (DKA) must have a MMTT performed no sooner than 2 weeks after resolution of the DKA event to have a qualifying C-peptide reading.
• Participants on systemic corticosteroids or any medication used to treat the symptoms of T1D (other than insulin) 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.
• Female participants of non-childbearing potential (e.g., surgical sterilization, no menses for a year).
• Women of childbearing potential (WOCBP) who have agreed not to become pregnant during the study, have a negative pregnancy test at Screening Visit, and agree to use 1 highly effective form of birth control starting at initial screening and continuing throughout the entire study to Day 365.
• Female participants who agree to not breastfeed starting at initial Screening and throughout the entire study to Day 365.
• Female participants who agree to not donate ova, including autologous, starting at initial Screening and throughout the entire study to Day 365.
• Male participant and with a spouse or partner of childbearing potential, who themselves and their spouse or partner agree to practice an effective form of birth control as discussed with the study doctor or study staff starting at Screening and throughout the entire study to Day 365.
• Participants must weigh \>35 kg at Screening for Cohort 1 (100 mg) and Cohort 2 (300 mg); participants must weigh \>50 kg at Screening for Cohort 3 (600 mg).
• Body mass index (BMI):
• Participants 12-17 years: BMI Z-Score within 5th and 95th percentile based on participant's age (e.g., Baylor College of Medicine Age-based Pediatric Growth Reference Charts: BMI Z-Score and Percentile Calculator)

You may not qualify if:

• Participants unable to comply with prohibited medication outlined in the protocol.
• Participants with a history of tuberculosis or positive Quantiferon test.
• Participants who received vaccinations in the following time frame:
• Any live vaccine within 28 days prior to Screening.
• Any subunit vaccine within 14 days prior to Screening.
• Any COVID-19 vaccine series within 14 days prior to Screening.
• Known or suspected acute infection, including COVID-19 at the time of Screening or within 2 weeks prior to Screening. After confirmed recent COVID-19 infection, a minimum of 2 weeks of recovery post-acute infection is required.
• Participants with Screening laboratory test results that are outside the normal limits and considered by the Investigator to be clinically significant.
• Participants with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen/antibody as determined at Screening.
• Participants with a history of or currently active immune disorders other than T1D (including autoimmune disease) unless the condition, after discussion with the Medical Monitor, has been deemed to be acceptable for the participant's participation in this study.
• Participants with a clinical history of significant cardiovascular disease in the past 12 months.
• Participants with a complication or medical history of malignant tumor, other than basal cell or squamous cell carcinomas of the skin.
• Participants who, in the Investigator's opinion, will be unable to adhere to study visits and procedures.
• Participants who have received investigational therapy other than CNP-103 within 28 days or 5 half-lives, whichever is longer, prior to Screening.
• Participants with any known active condition which, in the Investigator's opinion, makes the participant unsuitable for study participation.

Sponsors & Collaborators

• COUR Pharmaceutical Development Company, Inc.: lead

Study Sites (28)

Wake Research - Tucson

Tucson, Arizona, 85710, United States

RECRUITING

Rady Children's Hospital San Diego

San Diego, California, 92123, United States

RECRUITING

Diablo Clinical Research

Walnut Creek, California, 94598, United States

RECRUITING

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, 80045, United States

RECRUITING

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

RECRUITING

DY Professional Research Center

Miami, Florida, 33176, United States

RECRUITING

University of South Florida

Tampa, Florida, 33612, United States

RECRUITING

Atlanta Diabetes Association

Atlanta, Georgia, 30318, United States

RECRUITING

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

RECRUITING

Riley Hospital for Children- Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

Barry J. Reiner, MD, LLC

Baltimore, Maryland, 21229, United States

RECRUITING

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55454, United States

RECRUITING

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

UBMD Pediatrics - University of Buffalo

Buffalo, New York, 14203, United States

RECRUITING

MainStreet Health

Syosset, New York, 11791, United States

RECRUITING

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

Physicians East, PA

Greenville, North Carolina, 27834, United States

RECRUITING

Wake Research - Raleigh

Raleigh, North Carolina, 27612, United States

RECRUITING

Superior Clinical Research

Smithfield, North Carolina, 27577, United States

RECRUITING

Texas Diabetes & Endocrinology

Austin, Texas, 78749, United States

RECRUITING

M3 Wake Research - Dallas

Dallas, Texas, 75246, United States

RECRUITING

Accurate Clinical Research, Inc

Humble, Texas, 77346, United States

RECRUITING

Diabetes & Glandular Disease (DGD) Clinic, P.A.

San Antonio, Texas, 78229, United States

RECRUITING

TopLine Clinical, Inc

Waxahachie, Texas, 75165, United States

RECRUITING

University of Washington Diabetes Institute

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Paul Peloso, MD

  COUR Pharma

  STUDY DIRECTOR

Central Study Contacts

Stephanie Slaughter

CONTACT

317-727-2551; sslaughter@courpharma.com

Cristina Varela

CONTACT

901-517-2602; cvarela@courpharma.copm

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will enroll up to three cohorts across two 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).

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: May 12, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-03

Locations

US (28)