Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Pharmacokinetics, Safety, and Tolerability of SYN-020

7 de octubre de 2021 actualizado por: Synthetic Biologics Inc.

A Single Ascending Dose Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Orally Administered SYN-020 Delayed Release Capsules in Healthy Subjects

This is a Phase 1, single-center, open-label, single ascending dose study to assess the PK, safety, and tolerability of SYN-020 delayed release capsules administered orally to healthy adult male and female subjects with a BMI of 18.5 to 27 kg/m2. Up to 36 subjects will participate, in each of up to 6 sequential cohorts. Single doses of 5, 15, 45, and 150 mg SYN-020 are planned in Cohorts 1 through 4, respectively. Cohorts 5 and 6, if enrolled, will receive doses that were well tolerated in an earlier cohort to determine the effect of BMI and/or a high-fat meal on the SYN-020 PK profile.

For each cohort, eligible subjects will be admitted to the clinic on Day -1, and receive study drug in the morning of Day 1. For PK analysis, blood and feces will be collected before dosing and for up to 96 hours (blood) or 120 hours (feces) after dosing. Subjects will be discharged from the clinic after the End of Study procedures are completed on Day 6.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

Intestinal alkaline phosphatase (IAP) is a naturally occurring enzyme produced by the small intestine in all mammals, including humans, and is considered essential for promoting normal gastrointestinal (GI) function and maintaining proper gut homeostasis, as well as appearing to play a pivotal role in the mediation of inflammation.

SYN-020 is a recombinant bovine IAP isotype II being developed by Synthetic Biologics, Inc. to reduce the cumulative GI toxicity and inflammation that can be associated with repeat administration of radiation in patients with cancer.

This is a Phase 1, single-center, open-label, single ascending dose study to assess the PK, safety, and tolerability of SYN-020 delayed release capsules administered orally to healthy adult male and female subjects with a BMI of 18.5 to 27 kg/m2. Up to 36 subjects will participate, with 6 subjects (approximately equal numbers of male and females) in each of up to 6 sequential cohorts. Single doses of 5, 15, 45, and 150 mg SYN-020 are planned in Cohorts 1 through 4, respectively. Cohorts 5 and 6, if enrolled, will receive doses that were well tolerated in an earlier cohort to determine the effect of BMI and/or a high-fat meal on the SYN-020 PK profile, and will be described fully in a protocol amendment.

For each cohort, eligible subjects will be admitted to the clinical research unit (CRU) on Day -1, and subjects who remain eligible will, after a minimum 10-hour overnight fast, receive study drug in the morning of Day 1. For PK analysis, blood and feces will be collected before dosing and for up to 96 hours (blood) or 120 hours (feces) after dosing. Subjects will be discharged from the CRU after the End of Study (EOS) procedures are completed on Day 6.

Tipo de estudio

Intervencionista

Inscripción (Actual)

24

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

    • Wisconsin
      • West Bend, Wisconsin, Estados Unidos, 53095
        • Spaulding Clinical Research LLC

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 50 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Subject is able to read, write, and comprehend English at a sufficient level to understand study related materials, has provided written informed consent before any study-related procedure was performed, and is willing and able to comply with all testing and study requirements.
  2. Subject is a healthy male or female, aged 18 through 50 years, inclusive.
  3. Subject does not use any tobacco or nicotine product (eg, cigarette, pipe, e-cigarette, vape) and has not used any tobacco or nicotine product for at least 2 months before Day -1.
  4. Subject has a BMI of 18.5 to 27 kg/m2 for initial cohorts or, for exploratory cohorts, ≥ 27.1 kg/m2. For Cohorts 1 through 4, if insufficient subjects are available to meet this criterion, subjects with a BMI up to 29 kg/m2 may be included with written authorization from the Sponsor.
  5. Subject is healthy based on physical examination, clinical laboratory tests, 12-lead ECG, and vital signs.
  6. Subject is willing to minimize the risk of inducing pregnancy from the time of signing the informed consent form (ICF) to at least either 90 days (males) or 30 days (females) after the study drug dose.
  7. If female, subject has a negative serum pregnancy test at Screening and on Day -1 (CRU admission).
  8. Subject usually has at least 1 bowel movement a day based on self-reporting.

Exclusion Criteria:

  1. Subject has a history or the presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, vascular, metabolic, collagen, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
  2. Subject has any known malabsorption syndrome or history of gastrointestinal surgery that could compromise the study objectives.
  3. Subject has used any medication (prescription or non-prescription) or herbal supplement, other than prescription hormone replacement therapy (eg, thyroid, testosterone, estrogen) or contraception methods described in Inclusion Criterion #6, within 21 days before Day -1.
  4. Subject is pregnant, breastfeeding, or not using a medically accepted method of contraception.
  5. Subject is unable to abstain from artificial sweeteners (eg, aspartame, acesulfame potassium, advantame, saccharin, stevia, and sucralose) from CRU admission to the end of study participation.
  6. Subject has a positive urine drug or alcohol test at Screening or CRU admission OR has a history of drug/alcohol abuse within 12 months before Screening.
  7. Subject has donated more than 500 mL blood during the 3-month period before Day -1.
  8. Subject has known intolerance of study drug/ingredients.
  9. In the judgment of the Investigator, subject has any factor (eg, other treatment) that could invalidate the study result.
  10. Subject is currently enrolled in another clinical study or has received an investigational drug or device within 30 days or within a time period consistent with a washout period of 5 half-lives before signing the ICF, whichever is longer.
  11. Subject has already participated in this study.

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: No aleatorizado
  • Modelo Intervencionista: Asignación Secuencial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: SYN-020, 5 mg
6 subjects to receive a single 5 mg dose of SYN-020
SYN-020, is an opaque, white, size 3 HPMC capsule for oral administration containing enteric-coated, delayed-release pellets.
Otros nombres:
  • Intestinal Alkaline Phosphatase
Experimental: SYN-020, 15 mg
6 subjects to receive a single 15 mg dose of SYN-020
SYN-020, is an opaque, white, size 3 HPMC capsule for oral administration containing enteric-coated, delayed-release pellets.
Otros nombres:
  • Intestinal Alkaline Phosphatase
Experimental: SYN-020, 45 mg
6 subjects to receive a single 45 mg dose of SYN-020
SYN-020, is an opaque, white, size 3 HPMC capsule for oral administration containing enteric-coated, delayed-release pellets.
Otros nombres:
  • Intestinal Alkaline Phosphatase
Experimental: SYN-020, 150 mg
6 subjects to receive a single 150 mg dose of SYN-020
SYN-020, is an opaque, white, size 3 HPMC capsule for oral administration containing enteric-coated, delayed-release pellets.
Otros nombres:
  • Intestinal Alkaline Phosphatase

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
SYN-020 systemic absorption
Periodo de tiempo: Daily Day 1 through Day 5
Analysis of SYN-020 level present in blood
Daily Day 1 through Day 5
SYN-020 presence in feces
Periodo de tiempo: Daily Day -1 through Day 6
Analysis of SYN-020 level present in feces
Daily Day -1 through Day 6

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants with Changes in Clinical Laboratory Testing
Periodo de tiempo: Day -1, Day 2, Day 6
Hematology, clinical chemistry, urinalysis, virus serology, drug screen, alcohol screen, pregnancy test, postmenopausal screen
Day -1, Day 2, Day 6
Number of Participants With Changes in Physical exam
Periodo de tiempo: Day 1 and Day 6
Complete and abbreviated physical examinations will be performed
Day 1 and Day 6
Number of Participants with Changes in Vital Signs
Periodo de tiempo: Daily Day -1 through Day 6
Blood pressure, pulse rate, respiratory rate, oral temperature
Daily Day -1 through Day 6
Number of Participants with Changes in Electrocardiograms
Periodo de tiempo: Day -1, Day 1, Day 2, Day 6
12-lead ECG, P-wave, QRS-complex, QT-interval
Day -1, Day 1, Day 2, Day 6
Immunogenicity testing
Periodo de tiempo: Day 1, Day 6
Measurement of anti-drug antibodies by ELISA
Day 1, Day 6

Colaboradores e Investigadores

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

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)

22 de marzo de 2021

Finalización primaria (Actual)

18 de mayo de 2021

Finalización del estudio (Actual)

30 de septiembre de 2021

Fechas de registro del estudio

Enviado por primera vez

12 de marzo de 2021

Primero enviado que cumplió con los criterios de control de calidad

22 de marzo de 2021

Publicado por primera vez (Actual)

25 de marzo de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de octubre de 2021

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

7 de octubre de 2021

Última verificación

1 de marzo de 2021

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • SB-1-020-001

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

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.

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. .

Ensayos clínicos sobre SYN-020 delayed release capsule

3
Suscribir