Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

Bioavailability, Biopotency and Food Effect Study of SCD0503 Compared to Subcutaneous Regular Human Insulin

Q: Who can participate in NCT07634770?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT07634770?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

A Trial to Investigate the Relative Bioavailability, Relative Biopotency and Food Effect of SCD0503 (Oral Insulin) in Comparison to Subcutaneous Regular Human Insulin Under Euglycaemic Clamp Conditions and After Food Intake in People With Type I Diabetes

Bioavailability, Biopotency and Food Effect Study of SCD0503 Compared to Subcutaneous Regular Human Insulin (NCT07634770) is a Phase 1 interventional studying Diabetes Mellitus, Type 1, sponsored by Sam Chun Dang Pharm. Co. Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

Reason for the study The participants have been diagnosed with type 1 diabetes and are being treated with standard insulin therapy. The sponsor of the study is developing a new insulin-based medicine that can be taken by mouth (orally). For this reason, the investigational product named SCD0503 is to be tested in the study. The sponsor wants to investigate the course of blood concentrations and the blood sugar-lowering effect of the investigational product and to find out whether SCD0503 is safe. Investigational product tested in this study The investigational product tested, SCD0503, is still under clinical evaluation and has not yet been approved for your treatment. The active ingredient is regular human insulin, which has been used for many years in approved medicines for the treatment of diabetes. SCD0503 is being used in humans for the first time in this study. Study procedures The study will last for approximately 1 to 4 months. During this time, the participant will come to the investigational site 8 times for visits. During 4 visits the participant will undergo a clamp examination. The blood sugar-lowering effect of the investigational product is determined using a clamp device, a computer-controlled device that maintains blood sugar at a constant level within the normal range. This is achieved by infusing a sugar solution. During 2 further visits the participant will have a meal test. During the meal test, the blood sugar-lowering effect of the investigational product is determined after intake of a standardized meal as breakfast. You will have catheters in your arms to take blood, measure your blood sugar level and to infuse glucose (sugar) or insulin, if needed. SCD0503 is compared with a regular human insulin already approved for the treatment of diabetes. The participant will receive SCD0503 and the comparator product during different visits to the investigational site. The participant will also receive a placebo together with the investigational or the comparator product. The placebo looks identical but contains no active ingredient. As the investigational product is administered orally and the comparator product is injected under the skin, two placebos are used in this study. The order of medications given will be decided by chance, using a pre-defined method called randomization (a procedure similar to flipping a coin). Neither the participant nor the study physician will know which of the 2 medicines is administered at the respective dosing occasion. However, in case of emergency, this information will be quickly available.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Diabetes Mellitus, Type 1, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 16 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Male person with type 1 diabetes mellitus - Age between 18 and 64 years, both inclusive - Body Mass Index (BMI) between 18.5 and 29.9 kg/m2, both inclusive - HbA1c ≤ 8.5% - Fasting C-peptide \<= 0.20 nmol/L - Total insulin dose of \<1.2 (I)U/kg/day - Diabetes duration of at least 12 months at the time of screening - Stable insulin regimen for at least 2 months prior to inclusion into the trial Who Should NOT Join This Trial: - Systolic blood pressure \< 90 mmHg or \>139 mmHg and/or diastolic blood pressure \< 50 mmHg or \> 89 mmHg - Heart rate at rest outside the range of 50- 90 beats per minute - Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position at screening - Proliferative retinopathy or maculopathy as judged by the investigator based on a recent (\<1 year) ophthalmologic examination - Peripheral neuropathy - More than one episode of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months pior to screening - Hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening - Significant history of alcoholism or drug abuse - Smoking more than 5 cigarettes or the equivalent per day - Tested positive for hepatitis Bs antigen - Tested positive for hepatitis C antibodies - Positive result to the test for HIV-1/2 antibodies or HIV-1 antigen - Estimated glomerular filtration rate (eGFR) \< 60.0 mL/min/1.73m2 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Male person with type 1 diabetes mellitus * Age between 18 and 64 years, both inclusive * Body Mass Index (BMI) between 18.5 and 29.9 kg/m2, both inclusive * HbA1c ≤ 8.5% * Fasting C-peptide \<= 0.20 nmol/L * Total insulin dose of \<1.2 (I)U/kg/day * Diabetes duration of at least 12 months at the time of screening * Stable insulin regimen for at least 2 months prior to inclusion into the trial Exclusion Criteria: * Systolic blood pressure \< 90 mmHg or \>139 mmHg and/or diastolic blood pressure \< 50 mmHg or \> 89 mmHg * Heart rate at rest outside the range of 50- 90 beats per minute * Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position at screening * Proliferative retinopathy or maculopathy as judged by the investigator based on a recent (\<1 year) ophthalmologic examination * Peripheral neuropathy * More than one episode of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months pior to screening * Hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening * Significant history of alcoholism or drug abuse * Smoking more than 5 cigarettes or the equivalent per day * Tested positive for hepatitis Bs antigen * Tested positive for hepatitis C antibodies * Positive result to the test for HIV-1/2 antibodies or HIV-1 antigen * Estimated glomerular filtration rate (eGFR) \< 60.0 mL/min/1.73m2

Treatments Being Tested

BIOLOGICAL

oral insulin

test product

OTHER

Placebo A

placebo for test product

BIOLOGICAL

subcutaneous insulin

reference product/comparator

OTHER

Placebo B

placebo for reference product

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Profil Institut für Stoffwechselforschung GmbH

Neuss, North Rhine-Westphalia, Germany

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07634770), the sponsor (Sam Chun Dang Pharm. Co. Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07634770 clinical trial studying?

Who can participate in NCT07634770?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07634770?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

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Source: ClinicalTrials.gov API v2 record for NCT07634770. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07634770. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.