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

ConditionsType 1 Diabetes MellitusT1DT1DMT1DM - Type 1 Diabetes MellitusType 1 Diabetes in AdolescenceType 1 Diabetes in ChildrenType 1 Diabetes (Juvenile Onset)Type 1 DiabetesType 1 Diabetes PatientsType 1 Diabetes Mellitis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12-35
SponsorCOUR Pharmaceutical Development Company, Inc.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Participants unable to comply with prohibited medication outlined in the protocol.

Exclusion of additional immunomodulation will be at the discretion of the Medical Monitor and study site Investigator.

Participants with a history of tuberculosis or positive Quantiferon test.

Any live vaccine within 28 days prior to Screening.

Trial design

Design model

Parallel

Treatments tested in this trial

  • CNP-103

    Drug

    CNP-103

  • Placebo

    Drug

    0.9% sodium chloride for injection

Treatment groups

72 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Adult Cohort 1 (100 mg CNP-103)Experimental treatment 2 interventions
Group B: Adult Cohort 2 (300 mg CNP-103)Experimental treatment 2 interventions
Group C: Adult Cohort 3 (600 mg CNP-103)Experimental treatment 2 interventions
Group D: Adolescent Cohort 1 (100 mg CNP-103)Experimental treatment 2 interventions
Group E: Adolescent Cohort 2 (300 mg CNP-103)Experimental treatment 2 interventions
Group F: Adolescent Cohort 3 (600 mg CNP-103)Experimental treatment 2 interventions
Group G: Expansion CohortExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Safety

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

Time frame
Day 1 Through Day 365
2

Immune Safety

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

Time frame
Day 1 Through Day 365

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

COUR Pharmaceutical Development Company, Inc.

Lead sponsor

Source ClinicalTrials.gov
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