Diabetes Mellitus, Type 1Phase 1NCT05428943
OPT101 in Type 1 Diabetes Patients
A Phase 1 study testing OPT101 in people with Diabetes Mellitus, Type 1, run by Op-T LLC at 2 sites in United States.
Trial summary
Phase 1b designed to assess safety, pharmacokinetics, immunological and clinical effects of multiple ascending doses of OPT101. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- OPT101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Sep 2022to 21 Feb 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Able and willing to give informed consent for the trial
- Male or female aged ≥18 years on the day of signing informed consent
- Diagnosis of Type 1 diabetes (T1D) within the last 20 years
- Is medically stable based on physical examination, medical history, laboratory results, and vital signs performed at screening
- Women of childbearing potential must have a negative highly sensitive serum test (beta-human chorionic gonadotropin) at screening and a negative urine pregnancy test at the Visit 1 Day 1 prior to receiving the investigational product.
- Women must agree to use one of the following methods of birth control for the duration of the clinical trial: systemic hormonal contraceptive (oral, injected, transdermal), intrauterine device, double barrier (e.g., cervical cap or diaphragm with condom or spermicide). Men with female partners must agree to use double barrier contraception, unless their partner is using systemic hormonal contraceptives or has an intrauterine device.
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Who cannot join
- Is over the age of 60 years old
- Currently has or had a history of malignancy
- Has an immune deficiency syndrome (for example, severe combined immunodeficiency syndrome, T-cell deficiency syndromes, B-cell deficiency syndromes, or chronic granulomatous disease), or bone marrow or organ transplantation, or a disease associated with lymphopenia
- Is currently receiving an immuno-modulatory treatment.
- Patients with a history of venous and arterial thromboembolic events including, but not limited to, the following: deep venous thrombosis, pulmonary embolism, myocardial infarction, stroke, transient ischemic attack, or arterial insufficiency causing digital gangrene should be excluded. In addition, patients with recent immobilization or recent surgery, should be excluded. Patients with a history of abnormal prothrombotic laboratories such as congenital or inherited deficiency of antithrombin III, protein C, protein S, or confirmed diagnosis of antiphospholipid syndrome should also be excluded.
- Has active infections, is prone to infections or has chronic, recurrent or opportunistic infectious disease, including but not limited to, Epstein-Barr virus (EBV), cytomegalovirus (CMV) chronic renal infection, chronic chest infection, sinusitis, recurrent urinary tract infection, Pneumocystis carinii, aspergillosis, latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis or an open, draining, or infected non-healing skin wound or ulcer
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- Has recent or active hepatitis A infection, current/chronic hepatitis B and hepatitis C infection, or HIV infection. Participants with immunity to hepatitis B from previous infection (defined as negative HBsAg, positive anti-HBc, and positive hepatitis B surface antibody [anti-HBs]) or vaccination (defined as negative HBsAg, negative anti-HBc, and positive anti-HBs) may be eligible to participate.
- Has a history of latent or active TB
- Has received a live (attenuated) vaccine within the last 60 days, including patients who plan to receive live (attenuated) vaccines during the study or within 60 days after the final dose of study treatment.
- Patients with clinically significant abnormal laboratory test values in screening blood samples. In particular patients with the following should be excluded:
- Patients with abnormal coagulation panel at screening such as abnormal PT or aPTT or fibrinogen ii. Abnormal liver function tests:
- 1. Liver enzyme abnormalities (except in the case of known Gilbert's syndrome) 2. AST or ALT ≥3x ULN and total bilirubin ≥2x ULN 3. AST or ALT ≥5x ULN 4. AST or ALT ≥3x ULN if associated with appearance or worsening of rash or hepatitis symptoms iii. Abnormal platelet counts (<150,000mcL or > 450,000mcL) iv. Abnormal white blood cell counts (<3mL or > 11mL) v. Abnormal eGFR (<50mg/dL or >1.10mg/dL) vi. Abnormal Factor VIII (> 160%) vii. Abnormal D-Dimer (> 500ng/mL FEU) 11. Patients planning to undergo elective procedures or surgeries at any time after signing the ICF through the follow-up visit.
- 12. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
- 13. Recent history of bleeding or bleeding disorders or any condition whereby in the opinion of the treating investigator giving anti-coagulation during treatment would be contraindicated.
- 14. History of hypersensitivity to antihistamines. 15. Weight is over 250lbs. 16. Patients with active drug or alcohol abuse within 1 year prior to screening 17. Patient is participating in a clinical trial of another investigational drug or device, including patients who have participated in another study for a duration of 5 half-lives of the investigational agent.
- 18. Patient is a prisoner 19. Investigators could exclude patients with any medical condition, including, but not limited to, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or a psychiatric condition that, in the opinion of the Investigator, could compromise the participant's ability to participate in this study.
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Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rainier Clinical Research Center
Renton, Washington, 98057
Diablo Clinical Research Center
Walnut Creek, California, 94598
About this study
Official title: A Phase 1b Study of OPT101 in Patients With Type 1 Diabetes
Phase 1b designed to assess safety, pharmacokinetics, immunological and clinical effects of multiple ascending doses of OPT101.
Read the detailed description
This study is a randomized, multicenter, placebo-controlled, double blinded study that will be conducted as a multiple ascending doses (MAD) study to measure safety, the immunological, and the clinical effects of 1.1 and 2.8 mg/kg doses of OPT101 that were found to be safe in the OPT-100-30 (IND 150941) Phase 1a study performed in healthy volunteers.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- OPT101
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPT101Drug
15-mer peptide derived from the sequence of mouse CD154.
| Study group | Role | What they receive |
|---|---|---|
| OPT101 1.1 mg/kg and Placebo | Other | 9 subjects (6 investigational product:3 placebo) Receives: Drug: OPT101 |
| OPT101 2.8 mg/kg and Placebo | Other | 9 subjects (6 investigational product:3 placebo) Receives: Drug: OPT101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment-related AE's as Assessed by CTCAE v4.0
Number of treatment-related adverse events as assessed by CTCAE v4.0 over 42 days for all participants.
Measured: 42 days
Secondary outcomes (7)
Serum Samples Collected to Determine AUC0-t
Blood samples will be collected to determine the serum concentrations of OPT101 (mg/kg)
Measured: 42 days
Serum Samples Collected to Determine Cmax
Blood samples will be collected to determine the serum Cmax levels of OPT101 (pg/mL)
Measured: 42 Days
Serum Samples Collected to Determine CL/F
Blood samples will be collected to determine the CL/F values of OPT101 (mL/min/kg)
Measured: 42 days
Serum Samples Collected to Determine t1/2
Blood samples will be collected to determine the serum concentrations of OPT101 (mg/kg)
Measured: 42 days
Serum Samples Collected to Determine HbA1C From Baseline Pre Mixed Meal Tolerance Test to Day 56 Pre Mixed Meal Tolerance
Serum samples collected to determine HbA1C levels from baseline pre mixed meal tolerance to Day 56 pre mixed meal tolerance test of OPT101 (mmol/mole)
Measured: 56 days
Serum Samples Collected to Determine C-peptide Post Mixed Meal Tolerance Test
Serum samples collected to determine C-Peptide values (ng/mL), post mixed-meal tolerance for End of Study (EOS).
Measured: 42 days
Serum Samples Collected to Determine Glucose Levels Post Mixed Meal Tolerance Test at End-of-Study
Serum samples collected to determine glucose levels (mmol/L) post mixed meal tolerance test at End-of-Study
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start27 Sep 2022
- Primary completion21 Feb 2024
- Study completion21 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Op-T LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Boswell, MS, Study director, OP-T
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428943
- Sponsor's protocol ID
- OPT101-100-20
- Status last verified
- May 2026
- First submitted
- 9 Jun 2022
- Last updated
- 10 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study of OPT101 in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05428943
- Acronym / sponsor ID
- OPT101-100-20
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Op-T LLCIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 21 Feb 2024 (actual)
- Study completion
- 21 Feb 2024 (actual)
- First posted
- 23 Jun 2022 (actual)
- Results
- Posted 10 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 1b designed to assess safety, pharmacokinetics, immunological and clinical effects of multiple ascending doses of OPT101.
Detailed description
This study is a randomized, multicenter, placebo-controlled, double blinded study that will be conducted as a multiple ascending doses (MAD) study to measure safety, the immunological, and the clinical effects of 1.1 and 2.8 mg/kg doses of OPT101 that were found to be safe in the OPT-100-30 (IND 150941) Phase 1a study performed in healthy volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPT101 1.1 mg/kg and Placebo | Other | Drug: OPT1019 subjects (6 investigational product:3 placebo) |
| OPT101 2.8 mg/kg and Placebo | Other | Drug: OPT1019 subjects (6 investigational product:3 placebo) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Able and willing to give informed consent for the trial
- Male or female aged ≥18 years on the day of signing informed consent
- Diagnosis of Type 1 diabetes (T1D) within the last 20 years
- Is medically stable based on physical examination, medical history, laboratory results, and vital signs performed at screening
- Women of childbearing potential must have a negative highly sensitive serum test (beta-human chorionic gonadotropin) at screening and a negative urine pregnancy test at the Visit 1 Day 1 prior to receiving the investigational product.
Key exclusion criteria (17 listed)
- Is over the age of 60 years old
- Currently has or had a history of malignancy
- Has an immune deficiency syndrome (for example, severe combined immunodeficiency syndrome, T-cell deficiency syndromes, B-cell deficiency syndromes, or chronic granulomatous disease), or bone marrow or organ transplantation, or a disease associated with lymphopenia
- Is currently receiving an immuno-modulatory treatment.
- Patients with a history of venous and arterial thromboembolic events including, but not limited to, the following: deep venous thrombosis, pulmonary embolism, myocardial infarction, stroke, transient ischemic attack, or arterial insufficiency causing digital gangrene should be excluded. In addition, patients with recent immobilization or recent surgery, should be excluded. Patients with a history of abnormal prothrombotic laboratories such as congenital or inherited deficiency of antithrombin III, protein C, protein S, or confirmed diagnosis of antiphospholipid syndrome should also be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPT10115-mer peptide derived from the sequence of mouse CD154. | Drug | OPT101 1.1 mg/kg and Placebo, OPT101 2.8 mg/kg and Placebo |
Primary outcome
Number of Treatment-related AE's as Assessed by CTCAE v4.0
Time frame: 42 days
Number of treatment-related adverse events as assessed by CTCAE v4.0 over 42 days for all participants.
7 secondary outcomes
Serum Samples Collected to Determine AUC0-t
Time frame: 42 days
Serum Samples Collected to Determine Cmax
Time frame: 42 Days
Serum Samples Collected to Determine CL/F
Time frame: 42 days
Serum Samples Collected to Determine t1/2
Time frame: 42 days
Serum Samples Collected to Determine HbA1C From Baseline Pre Mixed Meal Tolerance Test to Day 56 Pre Mixed Meal Tolerance
Time frame: 56 days
Serum Samples Collected to Determine C-peptide Post Mixed Meal Tolerance Test
Time frame: 42 days
Serum Samples Collected to Determine Glucose Levels Post Mixed Meal Tolerance Test at End-of-Study
Time frame: 42 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Boswell, MS study director
OP-T
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OPT101 in people with Diabetes Mellitus, Type 1, run by Op-T LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Treatment-related AE's as Assessed by CTCAE v4.0 (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.