NCT07634770|RecruitingPhase 1

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

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

Sam Chun Dang Pharm. Co. Ltd.ClinicalTrials.gov

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2 other identifiers

SCD-4E0012024-519502-12

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJun 2026

StartedMay 2026

CompletionOct 2026

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_1

Timeline

3mo left

Started May 2026

Shorter than P25 for phase_1

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4 months study duration

Study Progress14%

May 2026Oct 2026

First Submitted

Initial submission to the registry

May 26, 2026

Completed

3 days until next milestone

Study Start

First participant enrolled

May 29, 2026

Completed

11 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed

4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

May 26, 2026

Last Update Submit

June 2, 2026

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (4)

AUCins.0-6h, area under the serum insulin concentration curve from 0 to 6 hours
From enrollment to the end of treatment in 4 months
Cins.max, maximum observed insulin concentration
From enrollment to the end of treatment in 4 months
AUCGIR.0-6h, area under the insulin concentration-time curve from 0 to 6 hours
From enrollment to the end of treatment in 4 months
GRELcl, Relative biopotency (will be derived of the dose corrected ratio of AUCGIR.0-6h for oral and sc insulin)
From enrollment to the end of treatment in 4 months

Secondary Outcomes (20)

AUCins.0-1h, AUCins.0-2h, AUCins.0-4h, areas under the serum insulin concentration curve in the indicated time intervals
From enrollment to the end of treatment in 4 months
tmax.ins., time to maximum observed insulin concentration
From enrollment to the end of treatment in 4 months
λz, terminal elimination rate constant of insulin
From enrollment to the end of treatment in 4 months
t½ is the terminal serum elimination half-life calculated as t½=ln2/λz
From enrollment to the end of treatment in 4 months
MRT, Mean residence time (h)
From enrollment to the end of treatment in 4 months
+15 more secondary outcomes

Study Arms (8)

Sequence 1: SCD0503 low dose-SCD0503 medium dose-Actrapid-SCD0503 high dose-SCD0503 medium -Actrapid

EXPERIMENTAL

SCD0503 low dose: placebo B (subcutaneous injection)/ SCD0503 low dose + Placebo A medium dose (oral) SCD0503 medium dose: placebo B (subcutaneous injection)/ SCD0503 medium dose + Placebo A low dose (oral) SCD0503 high dose: placebo B (subcutaneous injection)/ SCD0503 high dose (oral) Actrapid: subcutaneous insulin/ Placebo A high dose (oral)