Activo, sin reclutamientoNCT07042594Registro de ClinicalTrials.gov

Single Ascending Doses Phase I Study to Evaluate the Safety and Pharmacokinetics of RBD1119 in Healthy Participants

Healthy Volunteers

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LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio: De intervención
Fase: Fase 1
Rango de edad: 18 años - 65 años
Sexo admitido: Todos los sexos
Voluntarios sanos: Aceptados
Participantes: 32 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

This is a Randomized, Single-blind, Placebo-Controlled Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of Subcutaneously Administered RBD1119 in Healthy Participants.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Main Inclusion Criteria:

Male or female healthy participants (non-childbearing potential only), aged 18 to 65 years at screening, inclusive.
Body mass index (BMI) between 18 and 32 kg/m2, inclusive
APTT, Prothrombin time (PT), INR, thrombin time (TT) within normal reference range (as per the local laboratory).
Haematology results within normal range, unless deemed not clinically significant by the Principal Investigator or delegate. Platelet count however must be within normal range per the local laboratory reference ranges.
Healthy as determined by no clinically significant findings by the Principal Investigator or delegate in medical history, vital signs, physical examination, clinical laboratory assessments, and 12-lead electrocardiogram (ECG).

Main Exclusion Criteria:

Any uncontrolled or serious disease that may interfere with participation in the clinical trial and/or put the participant at significant risk (according to Principal Investigator or delegate's judgment) if he/she participates in the clinical trial.
History or presence of cardiovascular disease (including peripheral artery and cerebrovascular disease).
Systolic blood pressure (SBP) is less than 90 or greater than 140 mmHg and/or diastolic blood pressure (DBP) is less than 50 or greater than 95 mmHg after 10 minutes of supine rest, unless determined by the Principal Investigator or delegate to be not clinically significant.
Diagnosis of diabetes mellitus, history of gestational diabetes that has not been fully resolved is not permitted.
History or presence of:

Bleeding disorder(s) and/or at risk of bleeding, including relevant familial history, such as Hemophilia A, Hemophilia B, Wiskott-Aldrich syndrome, von Willebrand disease (vWD);
Clinically significant anemia, in the opinion of the Principal Investigator or delegate;
Thromboembolic diseases;
Bleeding in the gastrointestinal tract or central nervous system;
Anticipated need for oral surgery or tooth extractions during the trial period;
Bleeding in the genitourinary tract;
Gum disease or active gum bleeding;
Planned surgery during the trial period.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: Asignación al azar
Enmascaramiento: Enmascaramiento simple

RBD1119 SAD experimental group

Subjects in SAD experimental groups will receive a single subcutaneous injection of RBD1119 on Day 1.

Drug: RBD1119

Placebo SAD group

Subjects in SAD placebo groups will receive a single subcutaneous injection of placebo on Day 1

Drug: Placebo

RBD1119 DRUG

Subcutaneously Administered RBD1119 in Healthy Subjects.

Placebo DRUG

Subcutaneously Administered Placebo in Healthy Subject.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.