No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
12 – 35
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
72 (estimated)
Sponsor
COUR Pharmaceutical Development Company, Inc. · Industry
Who this trial is looking for
This trial is looking for teenagers and young adults aged 12-35 who have been diagnosed with Type 1 Diabetes in the last 6 months. Participants will take a study medication called CNP-103 and will be monitored for safety and effectiveness over about a year.
Are You a Good Fit for This Trial?
Must be takingInsulin
You may be able to join if
I am between 12 and 35 years old.
I have been diagnosed with Stage 3 Type 1 Diabetes in the last 6 months.
I weigh more than 35 kg (or 50 kg for a higher dose).
I am following a diabetes management plan that includes insulin.
I am willing to follow study rules and attend all appointments.
I can provide consent if I’m over 18, or have a parent or guardian who can consent for me if I’m under 18.
I have a negative pregnancy test and will use birth control if I am a female of childbearing potential.
I agree not to breastfeed during the study.
You may not be able to join if
I cannot follow the medication guidelines in the study.
I have had tuberculosis or a positive test for it.
I received any live vaccine in the last 28 days.
I have had a significant cardiovascular issue in the past year.
I have active immune disorders other than Type 1 Diabetes.
I have tested positive for HIV, hepatitis B, or hepatitis C.
I have had a serious infection, including COVID-19, in the last 2 weeks.
I have a history of significant cancer other than non-melanoma skin cancers.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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).
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
1. Participants who are willing and able to provide Institutional Review Board (IRB) approved written informed consent and privacy language as per national regulations.
2. Men and non-pregnant, non-breast-feeding women ages 12-35 years inclusive.
3. Documented diagnosis of Stage…
Inclusion Criteria:
1. Participants who are willing and able to provide Institutional Review Board (IRB) approved written informed consent and privacy language as per national regulations.
2. Men and non-pregnant, non-breast-feeding women ages 12-35 years inclusive.
3. Documented diagnosis of Stage 3 T1D within 180 days prior to study enrollment according to American Diabetes Association (ADA) criteria.
4. 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.
5. Participants with a peak stimulated C-peptide of \>0.2 nmol/L measured from a screening mixed meal tolerance test (MMTT).
6. 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.
7. 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.
8. Female participants of non-childbearing potential (e.g., surgical sterilization, no menses for a year).
9. 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.
10. Female participants who agree to not breastfeed starting at initial Screening and throughout the entire study to Day 365.
11. Female participants who agree to not donate ova, including autologous, starting at initial Screening and throughout the entire study to Day 365.
12. 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.
13. 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).
14. Body mass index (BMI):
1. 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)
2. Participants 18-35 years: 18.0-30.0 (not inclusive)
Exclusion Criteria:
1. Participants unable to comply with prohibited medication outlined in the protocol.
2. Exclusion of additional immunomodulation will be at the discretion of the Medical Monitor and study site Investigator.
3. Participants with a history of tuberculosis or positive Quantiferon test.
4. Participants who received vaccinations in the following time frame:
1. Any live vaccine within 28 days prior to Screening.
2. Any subunit vaccine within 14 days prior to Screening.
3. Any COVID-19 vaccine series within 14 days prior to Screening.
4. Any other planned vaccine starting 14 days prior to Screening and through study Day 90 and 1 week after. (Note: The annual influenza vaccine is not an exclusion criterion.)
5. 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.
6. Participants with Screening laboratory test results that are outside the normal limits and considered by the Investigator to be clinically significant.
7. 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.
8. 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.
9. Participants with a clinical history of significant cardiovascular disease in the past 12 months.
10. Participants with a complication or medical history of malignant tumor, other than basal cell or squamous cell carcinomas of the skin.
11. Participants who, in the Investigator's opinion, will be unable to adhere to study visits and procedures.
12. Participants who have received investigational therapy other than CNP-103 within 28 days or 5 half-lives, whichever is longer, prior to Screening.
13. Participants with any known active condition which, in the Investigator's opinion, makes the participant unsuitable for study participation.
14. Known sensitivity to any components of CNP-103.
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