Health Trials

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

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

Treatments tested in this trial

  • CNP-103
  • Placebo

Treatment groups

72 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Locations

33
Arizona
Liver Institute PLLC85716, Tucson United States
Wake Research - Tucson85710, Tucson United States
California
Rady Children's Hospital San Diego92123, San Diego United States
Diablo Clinical Research94598, Walnut Creek United States

Sponsors and collaborators

COUR Pharmaceutical Development Company, Inc.

Lead sponsor

Source ClinicalTrials.gov