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GB-0669

Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GB-0669 in Healthy Adult Participants

Ensayo de Generate Biomedicines, Inc. en SARS CoV-2 (del registro, en inglés).

Fase

Fase 1

Estado

Completado

Participantes

51

previstos

Centros

1

Fin del objetivo primario

nov 2024

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, doble ciego. Comenzó en jul 2023.

Qué mide

To assess the safety and tolerability of a single ascending dose of GB-0669 administered intravenously in healthy volunteers (Day -1 to Day 302) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe goal of this clinical trial is to test the safety and tolerability of a single ascending dose (SAD) of GB-0669 administered intravenously in adults. The goal of this study is also to measure the blood levels of GB-0669 in the body. Study participants will be assigned to receive the study drug or placebo (the placebo is called saline; it is a liquid like salt water and made to look like the study drug but contains no active ingredient). The study is blinded, which means you and the study doctor will not know whether you are getting the study drug or placebo. Study participants will be assigned to one of 5 cohorts (study groups). Each cohort will have a single ascending dose (SAD). The first two SAD cohorts will have 3 study participants receiving GB-0669 and 3 study participants receiving placebo. The last three SAD cohorts will have 10 study participants receiving GB-0669 and 3 study participants receiving placebo. The SAD cohort dose levels will be as follows: 100 mg, 300 mg, 600 mg, 1200 mg, 2400 mg.

Más ensayos de GENB

Todos los de GENB, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT07050511), actualizada en jun 2025.