Calendario›ABSI›SAD IV Dose 1
SAD IV Dose 1
Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Adults With and Without Androgenetic Alopecia
Ensayo de Absci Corp en Alopecia androgenetica (AGA) · Voluntarios sanos - Hombres y mujeres.
- Fase
- Fase 1/2
- Estado
- Reclutando pacientes
- Participantes
- 227
- Centros
- 4
- Fin del objetivo primario
- jul 2028
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en dic 2025.
Qué mide
Tasa de incidencia de acontecimientos adversos relacionados con el tratamiento (From enrollment to the end of the Study (SAD approximately 12 months, MAD approximately 18 months)) (del registro, en inglés)
Qué se prueba
Se evalua si ABS-201 es seguro y tolerable para mejorar el crecimiento del cabello, primero en voluntarios sanos y despues en personas con ciertos tipos de caida del cabello, comparandolo con placebo durante aproximadamente un ano.
Lo que dice el documentoThe goal of this clinical trial is to learn if ABS-201 (a new medication) is safe and tolerable when used to improve hair growth in men and women. The trial will start with healthy volunteers and if safe, will treat participants with certain types of hair loss.
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 first-in-human study of ABS-201, a new investigational medicine, in healthy adult men and women. Its main purpose is to find out whether ABS-201 is safe and well tolerated, as well as to understand how the body processes it and how it affects related biological markers. ABS-201 is being developed as a possible treatment for androgenetic alopecia (male- and female-pattern hair loss); its effect on hair growth has not yet been established. The study has two parts: in the single ascending dose (SAD) part, healthy adults receive one intravenous dose of ABS-201 or placebo; and in the multiple ascending dose (MAD) part, participants (including men with androgenetic alopecia) receive several subcutaneous doses of ABS-201 or placebo. The MAD part also evaluates the effect of ABS-201 on hair growth. The main questions it aims to answer are: What medical problems, if any, do participants experience when taking a single dose or many doses of ABS-201? How does the medication, ABS-201, compare to placebo (a look alike substance that does not contain any medication). Participants who qualify for the trial will receive either ABS-201 or a placebo, and visit the study clinic for scheduled checkups and tests for approximately 12 months in the single ascending dose (SAD) part and approximately 18 months in the multiple ascending dose (MAD) part. In the MAD part, participants receive repeated subcutaneous doses.
Ficha completa en ClinicalTrials.gov (NCT07317544), actualizada en sep 2026.