A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
A Study of HB0017 Injection to Investigate PK After Subcutaneous Administration at Different Injection Sites in Healthy Volunteers, and to Evaluate Its Safety, Tolerability, and Pharmacokinetics in Low-body-weight Healthy Subjects
The goal of this clinical trial is to (PART 1) to evaluate the safety and tolerability of a single subcutaneous injection of HB0017 Injection in healthy subjects with low body weight; ( PART 2) to compare the pharmacokinetics (PK) of HB0017 following single subcutaneous administration at different injection sites at the same dose.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ying Wang, PhD
- Número de teléfono: 086-18367124548
- Correo electrónico: nancywangying@163.com
Ubicaciones de estudio
-
-
Zhejiang
-
Hangzhou, Zhejiang, Porcelana
- Reclutamiento
- First People's Hospital of Hangzhou
-
Investigador principal:
- Ying Wang, PhD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- PART1：bodyweight≤50 kg，at Screening；PART2：bodyweight at screening， female≥45 kg or male≥50 kg and BMI within 18~30（kg/m2）(including margin).
- Subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
- Subjects (including male subjects) have no pregnancy plans during the screening period and within 6 months after dosing, voluntarily use effective contraceptive measures, and have no plans to donate sperm or eggs.
Exclusion Criteria:
- Hypersensitivity to any component of the investigational drug (including excipients), or a history of severe allergic reaction to biologics, or at risk of allergic reactions upon study entry as judged by the investigator;
- History of psychiatric disorders.
- At screening, positive for any of the following in virological testing: hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), hepatitis B e antibody (HBeAb), hepatitis B core antibody (HBcAb), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab), or syphilis test.
- At screening, positive or equivocal interferon-gamma release assay (IGRA); or history of tuberculosis.
- Prior expose to anti-IL-17 or anti-IL-17 receptor antibody.
- Use of prescription or nonprescription drugs and dietary and herbal supplements within 2 weeks or 5 half lives (whichever is longer) prior to study intervention.
- Vaccination with a live attenuated vaccine within 8 weeks before randomization, or planned vaccination with a live attenuated vaccine during the study;
- Subjects deemed unsuitable for participation in this clinical trial by the investigator.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: PART1: Group 1,75mg
single-dose, SC, HB0017 75 mg or placebo |
pre-filled syringe, 150 mg/(1 mL)/per injection pre-filled syringe,1 mL/per injection |
|
Experimental: PART1: Group 2, 150mg
single-dose, SC, HB0017 150 mg or placebo |
pre-filled syringe, 150 mg/(1 mL)/per injection pre-filled syringe,1 mL/per injection |
|
Experimental: PART1: Group 3, 300mg
single-dose, SC, HB0017 300 mg or placebo |
pre-filled syringe, 150 mg/(1 mL)/per injection pre-filled syringe,1 mL/per injection |
|
Experimental: PART2: Group 4, 150mg, domen
single-dose, SC at domen, HB0017 150 mg |
pre-filled syringe, 150 mg/(1 mL)/per injection |
|
Experimental: PART2: Group 5, 150mg, upper arms
single-dose, SC at upper arms, HB0017 150 mg |
pre-filled syringe, 150 mg/(1 mL)/per injection |
|
Experimental: PART2: Group 6, 150mg, thihgs
single-dose, SC at thighs, HB0017 150 mg |
pre-filled syringe, 150 mg/(1 mL)/per injection |
|
Experimental: PART2: Group 7, 300mg, domen
single-dose, SC at domen, HB0017 300 mg |
pre-filled syringe, 150 mg/(1 mL)/per injection |
|
Experimental: PART2: Group 8, 300mg, upper arms
single-dose, SC at upper arms, HB0017 300 mg |
pre-filled syringe, 150 mg/(1 mL)/per injection |
|
Experimental: PART2: Group 9, 300mg, thighs
single-dose, SC at thighs, HB0017 300 mg |
pre-filled syringe, 150 mg/(1 mL)/per injection |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Adverse events
Periodo de tiempo: through study completion
|
PART 1: Number of participants experiencing adverse events as assessed by CTCAE v5.0. |
through study completion
|
|
Cmax
Periodo de tiempo: From pre-dosing to 140 days post-dosing
|
PART 2:Cmax was the maximum observed plasma concentration directly observed from data. Data analysis by group across injection sites - abdomen, upper arm, thigh - at the same dose. |
From pre-dosing to 140 days post-dosing
|
|
AUCinf
Periodo de tiempo: From pre-dosing to 140 days post-dosing
|
PART 2 : AUCinf was area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf , if data permits).Data analysis by group across injection sites - abdomen, upper arm, thigh - at the same dose. |
From pre-dosing to 140 days post-dosing
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
AUC
Periodo de tiempo: From pre-dosing to 140 days post-dosing
|
PART 1: Area under the plasma concentration-time curve, reflecting total systemic drug exposure. |
From pre-dosing to 140 days post-dosing
|
|
Cmax
Periodo de tiempo: From pre-dosing to 140 days post-dosing
|
PART 1: Maximum observed plasma concentration after drug administration. |
From pre-dosing to 140 days post-dosing
|
|
Tmax
Periodo de tiempo: From pre-dosing to 140 days post-dosing
|
PART 1: Time to reach the maximum observed plasma concentration after drug administration. |
From pre-dosing to 140 days post-dosing
|
|
Vz
Periodo de tiempo: From pre-dosing to 140 days post-dosing
|
PART 1: Apparent volume of distribution during the terminal elimination phase; a theoretical volume relating the amount of drug in the body to the plasma concentration. |
From pre-dosing to 140 days post-dosing
|
|
CL
Periodo de tiempo: From pre-dosing to 140 days post-dosing
|
PART 1: Volume of plasma cleared of drug per unit time, reflecting total systemic clearance. |
From pre-dosing to 140 days post-dosing
|
|
t1/2
Periodo de tiempo: From pre-dosing to 140 days post-dosing
|
PART 1: Time required for plasma drug concentration to decrease by 50% during the terminal elimination phase. |
From pre-dosing to 140 days post-dosing
|
|
Adverse events
Periodo de tiempo: through study completion (approximately 140 days)
|
PART 2: Number of participants experiencing adverse events as assessed by CTCAE v5.0. |
through study completion (approximately 140 days)
|
|
ADA
Periodo de tiempo: through study completion (approximately 140 days)
|
Number and percentage of participants with a positive anti-drug antibody (ADA) result. |
through study completion (approximately 140 days)
|
|
Nab
Periodo de tiempo: through study completion (approximately 140 days)
|
Number and percentage of participants with a positive neutralizing antibody (NAb) result. |
through study completion (approximately 140 days)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ying Wang, PhD, First People's Hospital of Hangzhou
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Espondiloartritis axial
- Enfermedades óseas
- Enfermedades musculoesqueléticas
- Artritis
- Enfermedades Articulares
- Enfermedades de la columna
- Espondiloartropatías
- Anquilosis
- Enfermedades De La Piel Papuloescamosa
- Enfermedades de la piel
- Espondiloartritis
- Espondilitis
- Enfermedades de la piel y del tejido conectivo
- Espondilitis Anquilosante
- Soriasis
Otros números de identificación del estudio
- HB0017-HV-01-02
- CTR20255233 (Otro identificador: China Drug Clinical Trial Registry)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .