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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

12 Years - 35 Years

Healthy Volunteers

Not accepted

Interventions

• CNP-103 — DRUG
  CNP-103
• Placebo — DRUG
  0.9% sodium chloride for injection

Study Details

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).

Key Dates

Start date

May 12, 2025

Status verified

Mar 2026

Primary completion

Dec 31, 2026

Completion

Jun 30, 2027

Study Design

Enrollment

72 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Adult Cohort 1 (100 mg CNP-103)
  Three (3) IV administrations of CNP-103 (100 mg) on Days 1, 8, and 90
• Experimental: Adult Cohort 2 (300 mg CNP-103)
  Three (3) IV administrations of CNP-103 (300 mg) on Days 1, 8, and 90
• Experimental: Adult Cohort 3 (600 mg CNP-103)
  Three (3) IV administrations of CNP-103 (600 mg) on Days 1, 8, and 90
• Experimental: Adolescent Cohort 1 (100 mg CNP-103)
  Three (3) IV administrations of CNP-103 (100 mg) on Days 1, 8, and 90
• Experimental: Adolescent Cohort 2 (300 mg CNP-103)
  Three (3) IV administrations of CNP-103 (300 mg) on Days 1, 8, and 90
• Experimental: Adolescent Cohort 3 (600 mg CNP-103)
  Three (3) IV administrations of CNP-103 (600 mg) on Days 1, 8, and 90
• Experimental: Expansion Cohort
  Dosing for the Expansion Cohort will be determined from Escalation Phase results

Primary Outcome Measure

Safety [ Time Frame: Day 1 Through Day 365 ]

Central Contacts

• Stephanie Slaughter
  317-727-2551
  [email protected]
• Cristina Varela
  901-517-2602
  [email protected]

Locations (30)

Find similar trials in Tucson, AZ

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