Calendario›GENB›GB-7624
GB-7624
Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GB-7624 in Healthy Adult Participants
Ensayo de Generate Biomedicines, Inc. en Atopic Dermatitis (AD) (del registro, en inglés).
- Fase
- Fase 1
- Estado
- En marcha, sin reclutar
- Participantes
- 40
- Centros
- 1
- Fin del objetivo primario
- ago 2026
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, doble ciego. Comenzó en mar 2025.
Qué mide
Composite Outcome: To assess the safety and tolerability of single doses of GB-7624 administered subcutaneously (SC) in healthy volunteers. (Day -1 to Day 360) (del registro, en inglés)
Qué se prueba
Se prueba GB-7624 frente a placebo en voluntarios sanos, evaluando seguridad, tolerabilidad, farmacocinetica, farmacodinamica e inmunogenicidad, con dosis subcutaneas unicas y multiples.
Lo que dice el documentoto evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity of GB-7624.
Traducción automática (claude-sonnet-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis is a randomised, double-blinded, placebo-controlled first in human (FIH) trial to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity of GB-7624. The trial will have two parts: a SAD component and a MAD component. Part A (SAD): a total of 24 healthy volunteers are planned to be enrolled across 3 SAD cohorts and will involve the administration of a single subcutaneous (SC) dose of GB-7624 (300 mg, 600 mg, or 1200 mg) or placebo on Day 1 in cohorts A1, A2, and A3. Part B (MAD): a total of 16 healthy volunteers are planned to be enrolled across 2 MAD cohorts and will involve the administration of multiple SC doses of GB-7624 (300 mg on Day 1 and Day 15 or 600 mg on Day1 and Day 15) or placebo in cohorts B1 and B2. The decision to escalate between dose levels in the SAD (Part A) and the MAD (Part B) as well as the decision to proceed from Part A to Part B will be based on safety review committee (SRC) review of prior cohorts, blinded available safety, tolerability and PK data. Study drug will be administered at the study site by trained study site personnel to ensure compliance. The administration of all trial intervention will be recorded in eCRF. Compliance will be assured by direct supervision and witnessing of trial intervention administration.
Más ensayos de GENB
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| GB-0895 | Fase 1 | En marcha, sin reclutar | may 2027 (prevista) |
| GB-4362 | Fase 1 | Reclutando pacientes | jun 2027 (prevista) |
| GB-0895 | Fase 3 | Reclutando pacientes | dic 2028 (prevista) |
| GB-0895 | Fase 3 | Reclutando pacientes | ene 2029 (prevista) |
| GB-0669 | Fase 1 | Completado | nov 2024 (real) |
Todos los de GENB, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT06920693), actualizada en dic 2025.