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Evaluar la seguridad y la farmacocinética/farmacodinámica de HS-20118

2 de noviembre de 2026 actualizado por: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Un estudio clínico de fase I para evaluar la seguridad, la tolerabilidad, la inmunogenicidad, la farmacocinética y la farmacodinámica de dosis ascendentes individuales y múltiples de HS-2018 en participantes adultos en adultos

The study will be conducted in 2 parts (SAD for Part 1 and MAD for Part2). Part 1 is a single-center, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability, immunogenicity, and PK of HS-20118 after a single oral dose in healthy participants.

Part 2 is a multi-center, randomized, double-blind, placebo-controlled, MAD study to evaluate the safety, tolerability, immunogenicity, PK, and PD of HS-20118 after multiple oral doses in patients with moderate to severe plaque psoriasis .

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

The study will be conducted in 2 parts (SAD for Part 1 and MAD for Part2). Part 1 is a single-center, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability, immunogenicity, and PK of HS-20118 after a single oral dose in healthy participants.

Part 1 will consist of 5 cohorts, i.e., X1 mg, X2 mg, X3 mg, X4 mg, and X5 mg dose cohorts (each cohort will include 3 participants to receive placebo). There will be no restriction on the male-to-female ratio. Each cohort will include 12 participants (HS-20118:placebo = 9:3), with a total of 60 participants. Participants will undergo PK blood sampling, ADA blood sampling, PD blood sampling and safety examinations during the study.

Part 2 is a multi-center, randomized, double-blind, placebo-controlled, MAD study to evaluate the safety, tolerability, immunogenicity, PK, and PD of HS-20118 after multiple oral doses in patients with moderate to severe plaque psoriasis.

Part 2 will tentatively consist of 6 cohorts ( HS-20118 vs placebo = 9:3), i.e., (1) A1 mg, (2) A2 mg, (3) A3 mg, (4) A4 mg, (5) A5 mg, (6) A6 mg. Each cohort will include 12 participants (HS-20118:placebo = 9:3), with a total of 72 participants. There will be no restriction on the male-to-female ratio. Participants will undergo PK blood sampling, ADA blood sampling, PD blood sampling and safety examinations during the study.

Tipo de estudio

Intervencionista

Inscripción (Actual)

60

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Anaheim, California, Estados Unidos, 92806
        • Kinetic Clinical Research
    • Florida
      • Miami Lakes, Florida, Estados Unidos, 33016
        • Clinitiative - Floridian Clinical Research, LLC
      • Pompano Beach, Florida, Estados Unidos, 33060
        • NuLine Clinical Trial Center (Network)
  • Nueva Zelanda
    • Auckland
      • Takapuna, Auckland, Nueva Zelanda, 0622
        • Pacific Clinical Research Network (PCRN), Auckland
    • Christchurch
      • Christchurch, Christchurch, Nueva Zelanda, 8013
        • Pacific Clinical Research Network (PCRN), Christchurch
    • Dunedin
      • Dunedin, Dunedin, Nueva Zelanda, 9016
        • Momentum Clinical Research, Dunedin
    • Pukekohe
      • Pukekohe, Pukekohe, Nueva Zelanda, 2120
        • Momentum Clinical Research, Pukekohe
    • Upper Hutt
      • Upper Hutt, Upper Hutt, Nueva Zelanda, 5018
        • Pacific Clinical Research Network (PCRN), Wellington
    • Wellington Region
      • Mount Cook, Wellington Region, Nueva Zelanda, 6021
        • Momentum Clinical Research, Wellington

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

For the SAD study:

  1. Healthy adults aged 18-45 years (inclusive) at the time of signing the informed consent form;
  2. Male participants weighing ≥ 50 kg and female participants weighing ≥ 45 kg, both ≤ 110 kg; body mass index (weight/square of height (kg/m2)) within the range of 18-28 kg/m2 (inclusive);
  3. Normal results or abnormal results but without clinical significance in comprehensive examinations, including general physical examination, vital signs, laboratory tests, 12-lead ECG, abdominal color Doppler ultrasound, and chest X-ray from the frontal and lateral position ;

For the MAD study:

  1. Male or female participants aged 18-65 years (inclusive) at the time of signing the informed consent form;
  2. Male participants weighing ≥ 50 kg and female participants weighing ≥ 45 kg, both ≤ 110 kg;
  3. Chronic plaque psoriasis for at least 6 months with or without psoriatic arthritis;

Exclusion Criteria:

For the SAD study:

  1. Participants with immune-related diseases and medical history at screening;
  2. Participants with a history of drug or other allergies who are considered by the investigator to be at high risk for participating in this study, or who may be allergic to the investigational medicinal product or any component of the investigational medicinal product as judged by the investigator;
  3. History of drug abuse within the past 5 years or use of illicit drugs within 3 months before the study; or positive for urine drug screening;

For the MAD study:

  1. Guttate psoriasis, pustular psoriasis, erythrodermic psoriasis, drug-induced psoriasis, or other diseases that affect the treatment results;
  2. Current use of illicit drugs or prior use of illicit drugs within the specific time periods;
  3. Known history of recurrent or chronic infections, or prior history of chronic or recurrent infections, including but not limited to: chronic renal infection, chronic chest infection (e.g., bronchiectasis), symptomatic urinary tract infection, and open, draining, or infected skin wounds; history of serious infections (e.g., sepsis, pneumonia, and pyelonephritis), or hospitalization or treatment with intravenous antibiotics for infections within 2 months before screening;

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación Secuencial
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: HS-20118

Single and multiple ascending doses of HS-20118 orally
Droga: HS-20118

Single and multiple ascending doses of HS-20118 orally
Comparador de placebos: placebo

Single and multiple ascending doses of HS-20118-matched placebo orally
Otro: HS-20118 placebo

Single and multiple ascending doses of HS-20118-matched placebo orally

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
Periodo de tiempo: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Number of participants with abnormalities of physical examination
Periodo de tiempo: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

Physical examination includes skin, mucous membranes, lymph nodes, head, neck, chest, abdomen, and spine/limbs, etc.
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Number of participants with abnormalities of vital signs
Periodo de tiempo: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

Vital sign measured include body temperature, blood pressure, pulse, and respiratory rate.
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Number of participants with clinical laboratory abnormalities
Periodo de tiempo: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

Clinical laboratory tests include blood biochemistry test, hematology test, urinalysis, coagulation function test, etc.
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Number of participants with abnormalities of electrocardiogram (ECG) parameters
Periodo de tiempo: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cmax
Periodo de tiempo: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

Maximum plasma concentration
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Tmax
Periodo de tiempo: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

Time to reach Cmax
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
AUC
Periodo de tiempo: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

Area under the plasma concentration-time curve
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
t½
Periodo de tiempo: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

Terminal half-life
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
CL/F
Periodo de tiempo: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

Apparent clearance
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Vd/F
Periodo de tiempo: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

Apparent volume of distribution
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Rac
Periodo de tiempo: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

Accumulation ratio
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Incidence of Anti-drug antibody (ADA)
Periodo de tiempo: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

Anti-drug antibody (ADA)
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Proportions of psoriasis area and severity index (PASI) 75
Periodo de tiempo: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

The PASI assessment will assess erythema, thickening (plaque evaluation, induration), and scaling (desquamation) on the head, trunk, upper limbs, and lower limbs, respectively
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Proportions of psoriasis area and severity index (PASI) 90
Periodo de tiempo: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

The PASI assessment will assess erythema, thickening (plaque evaluation, induration), and scaling (desquamation) on the head, trunk, upper limbs, and lower limbs, respectively
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Proportions of psoriasis area and severity index (PASI) 100
Periodo de tiempo: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

The PASI assessment will assess erythema, thickening (plaque evaluation, induration), and scaling (desquamation) on the head, trunk, upper limbs, and lower limbs, respectively
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Proportions of Investigator's Global Assessment (IGA) 0/1
Periodo de tiempo: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

The investigator scores each of infiltration/hypertrophy (I), erythema (E), and scaling (S) as a whole
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Proportions of Investigator's Global Assessment (IGA) 0
Periodo de tiempo: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

The investigator scores each of infiltration/hypertrophy (I), erythema (E), and scaling (S) as a whole
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Change from baseline in psoriasis area and severity index (PASI) total score
Periodo de tiempo: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

The PASI assessment will assess erythema, thickening (plaque evaluation, induration), and scaling (desquamation) on the head, trunk, upper limbs, and lower limbs, respectively
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Change from baseline in body surface area (BSA)
Periodo de tiempo: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

The total BSA affected by plaque psoriasis is estimated based on the percent area affected, including head, trunk, upper extremities, and lower extremities
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Change from baseline in dermatology life quality index (DLQI)
Periodo de tiempo: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne, and viral warts
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

2 de mayo de 2025

Finalización primaria (Actual)

14 de julio de 2026

Finalización del estudio (Actual)

14 de julio de 2026

Fechas de registro del estudio

Enviado por primera vez

12 de febrero de 2025

Primero enviado que cumplió con los criterios de control de calidad

20 de febrero de 2025

Publicado por primera vez (Actual)

26 de febrero de 2025

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

2 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • HS-20118-101

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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