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

2 de junho de 2026 atualizado por: Sam Chun Dang Pharm. Co. Ltd.

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

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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

16

Estágio

  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Clinical Manager
  • Número de telefone: please reach out by email
  • E-mail: scd.global@scd.co.kr

Locais de estudo

  • Alemanha
    • North Rhine-Westphalia
      • Neuss, North Rhine-Westphalia, Alemanha, 41460

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Ciência básica
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Sequence 1: SCD0503 low dose-SCD0503 medium dose-Actrapid-SCD0503 high dose-SCD0503 medium -Actrapid
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)
Biológico: oral insulin
test product
Outros nomes:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Outro: Placebo A
placebo for test product
Outros nomes:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biológico: subcutaneous insulin
reference product/comparator
Outros nomes:
  • Actrapid
Outro: Placebo B
placebo for reference product
Experimental: Sequence 2: SCD0503 low dose-SCD0503 medium dose-Actrapid-SCD0503 high dose-Actrapid-SCD0503 medium
Biológico: oral insulin
test product
Outros nomes:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Outro: Placebo A
placebo for test product
Outros nomes:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biológico: subcutaneous insulin
reference product/comparator
Outros nomes:
  • Actrapid
Outro: Placebo B
placebo for reference product
Experimental: Sequence 3: SCD0503 medium dose-SCD0503 high dose-SCD0503 low dose-Actrapid-SCD0503 medium-Actrapid
Biológico: oral insulin
test product
Outros nomes:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Outro: Placebo A
placebo for test product
Outros nomes:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biológico: subcutaneous insulin
reference product/comparator
Outros nomes:
  • Actrapid
Outro: Placebo B
placebo for reference product
Experimental: Sequence 4: SCD0503 medium dose-SCD0503 high dose-SCD0503 low dose-Actrapid-Actrapid-SCD0503 medium
Biológico: oral insulin
test product
Outros nomes:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Outro: Placebo A
placebo for test product
Outros nomes:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biológico: subcutaneous insulin
reference product/comparator
Outros nomes:
  • Actrapid
Outro: Placebo B
placebo for reference product
Experimental: Sequence 5: SCD0503 high dose-Actrapid-SCD0503 medium dose-SCD0503 low dose-SCD0503 medium-Actrapid
Biológico: oral insulin
test product
Outros nomes:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Outro: Placebo A
placebo for test product
Outros nomes:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biológico: subcutaneous insulin
reference product/comparator
Outros nomes:
  • Actrapid
Outro: Placebo B
placebo for reference product
Experimental: Sequence 6: SCD0503 high dose-Actrapid-SCD0503 medium dose-SCD0503 low dose-Actrapid-SCD0503 medium
Biológico: oral insulin
test product
Outros nomes:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Outro: Placebo A
placebo for test product
Outros nomes:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biológico: subcutaneous insulin
reference product/comparator
Outros nomes:
  • Actrapid
Outro: Placebo B
placebo for reference product
Experimental: Sequence 7: Actrapid-SCD0503 low dose-SCD0503 high dose-SCD0503 medium dose-SCD0503 medium-Actrapid
Biológico: oral insulin
test product
Outros nomes:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Outro: Placebo A
placebo for test product
Outros nomes:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biológico: subcutaneous insulin
reference product/comparator
Outros nomes:
  • Actrapid
Outro: Placebo B
placebo for reference product
Experimental: Sequence 8: Actrapid-SCD0503 low dose-SCD0503 high dose-SCD0503 medium dose-Actrapid-SCD0503 medium
Biológico: oral insulin
test product
Outros nomes:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Outro: Placebo A
placebo for test product
Outros nomes:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biológico: subcutaneous insulin
reference product/comparator
Outros nomes:
  • Actrapid
Outro: Placebo B
placebo for reference product

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
AUCins.0-6h, area under the serum insulin concentration curve from 0 to 6 hours
Prazo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
Cins.max, maximum observed insulin concentration
Prazo: From enrollment to the end of treatment in 4 months
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
Prazo: From enrollment to the end of treatment in 4 months
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)
Prazo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
AUCins.0-1h, AUCins.0-2h, AUCins.0-4h, areas under the serum insulin concentration curve in the indicated time intervals
Prazo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
tmax.ins., time to maximum observed insulin concentration
Prazo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
λz, terminal elimination rate constant of insulin
Prazo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
t½ is the terminal serum elimination half-life calculated as t½=ln2/λz
Prazo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
MRT, Mean residence time (h)
Prazo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
CL/F, Systemic clearance after oral administration (mL/min)
Prazo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
V/F, volume of distribution (L)
Prazo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
FRELcl, Relative bioavailability (will be derived from the dose corrected ratio of AUCins.0-6h for oral and sc insulin)
Prazo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
Cins.max.fed, maximum observed insulin concentration after meal test
Prazo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
AUCins.fed.0-1h, AUCins.fed.0-2h, AUCins.fed.0-4h, AUCins.fed.0-6h, areas under the serum insulin concentration curve in the indicated time intervals after meal test
Prazo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
FRELfed, Relative bioavailability (will be derived of the dose corrected ratio of AUCins.fed.0-6 for oral and sc insulin)
Prazo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
Food effect is investigated by comparing the total and maximum oral insulin exposure in the fasted state and after food intake
Prazo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
AUCGIR.0-1h, AUCGIR.0-2h and AUCGIR.0-4h, areas under the glucose infusion rate curve in the indicated time-intervals
Prazo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
GIRmax, maximum glucose infusion rate
Prazo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
tmax.GIR., time to maximum glucose infusion rate
Prazo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
t50%-GIR(early), time to half-maximum glucose infusion rate before GIRmax
Prazo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
t50%-GIR(late), time to half-maximum glucose infusion rate after GIRmax
Prazo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
Onset of action, time from trial product administration until plasma glucose concentration has decreased at least 5 mg/dL from baseline
Prazo: From enrollment to the end of treatment in 4 months
where baseline is defined as the mean of plasma glucose levels from -6, -4 and -2 minutes before trial product adminiadministration as measured by ClampArt
From enrollment to the end of treatment in 4 months
PGmax, maximum plasma glucose after meal test
Prazo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
AUCPG.0-1h, AUCPG.0-2h and AUCPG.0-4h and AUCPG.0-last areas under the plasma glucose concentration curve in the indicated time-intervals
Prazo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Sam Chun Dang Pharm. Co. Ltd.

Colaboradores

Profil Institut für Stoffwechselforschung GmbH

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

29 de maio de 2026

Conclusão Primária (Estimado)

1 de outubro de 2026

Conclusão do estudo (Estimado)

1 de outubro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

26 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

2 de junho de 2026

Primeira postagem (Real)

9 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • SCD-4E001
  • 2024-519502-12 (Número EudraCT)

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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