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NCT06783309

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

StatusRecruiting
PhasePhase 1/2
Primary completion (estimated)

At risk: Primary completion moved at least 7 months later.

See at-risk trials from COUR Pharmaceutical Development Company, Inc.

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Record History

All 20 versions: 19 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 2026 to Aug 2027
    • Eligibility criteria expanded, about 34 words
    • Study completion pushed from Jun 2027 to Dec 2027
    • Site details revised at 11 of 45 sites
  2. Trial sites expanded: 38 → 45 locationsv19
  3. Trial sites expanded: 35 → 38 locationsv18
  4. Trial sites expanded: 32 → 35 locationsv17
  5. Study sites: 33 to 32v16
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 32 to 33v15
  2. Study sites: 30 to 32v14
  3. Study sites: 28 to 30v13
  1. Trial sites reduced: 31 → 28 locationsv12
  2. Eligibility criteria expanded, about 441 wordsv11
  3. Study sites: 30 to 31v10
  4. Study sites: 28 to 30v9
  5. Study sites revised (28)v8
  6. Study sites: 19 to 28v7
  7. Study sites: 18 to 19v6
  8. Study sites: 17 to 18v5
  9. Eligibility criteria expanded, about 28 words
    • Study sites: 13 to 17
    v4
  10. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 13
    • Start date changed from estimate of Apr 2025 to May 12, 2025
    v3
  11. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Safety
Timeframe: Day 1 Through Day 365
Immune Safety
Timeframe: Day 1 Through Day 365

Arms and interventions

Adult Cohort 1 (100 mg CNP-103)Experimental

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

Adult Cohort 2 (300 mg CNP-103)Experimental

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

Adult Cohort 3 (600 mg CNP-103)Experimental

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

Adolescent Cohort 1 (100 mg CNP-103)Experimental

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

Adolescent Cohort 2 (300 mg CNP-103)Experimental

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

Adolescent Cohort 3 (600 mg CNP-103)Experimental

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

Expansion CohortExperimental

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

Drugs: CNP-103, Placebo

Sites

45 sites in 1 country