Calendario›ALGS›ALG-000184
ALG-000184
A Study of ALG-000184 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects
Ensayo de Aligos Therapeutics, Inc. en Hepatitis B cronica.
Más ensayos de: Hepatitis B crónica.
- Fase
- Fase 1
- Estado
- Completado
- Participantes
- 165
- Centros
- 10
- Fin del objetivo primario
- jun 2025
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en oct 2020.
Qué mide
Incidencia de acontecimientos adversos surgidos del tratamiento [Seguridad y tolerabilidad] (up to 8 days for Part 1) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe goal of this clinical trial is to learn if ALG-000184 is safe, well-tolerated, and works to treat chronic hepatitis B virus (HBV) infection. The main questions it aims to answer are: Is ALG-000184 safe and well-tolerated when given alone or with entecavir (a standard HBV treatment)? Does ALG-000184 reduce HBV viral levels in the blood of patients with chronic hepatitis B? How does the body process ALG-000184 (pharmacokinetics)? Researchers will compare ALG-000184 to placebo (a look-alike substance that contains no drug) to see if ALG-000184 works better at reducing hepatitis B viral markers. The study has five parts: Parts 1 and 2: Healthy volunteers will receive single or multiple doses of ALG-000184 or placebo Part 3: Patients with chronic hepatitis B will receive ALG-000184 or placebo daily for 28 days Part 4: Patients with chronic hepatitis B will receive ALG-000184 or placebo combined with entecavir for 12 weeks (may be extended up to 96 weeks) Part 5: Additional groups of patients with chronic hepatitis B will receive ALG-000184 with entecavir for 12 weeks (may be extended up to 96 weeks) Participants will: Take study medication orally as directed Visit the clinic regularly for blood tests, physical examinations, and other safety assessments Have their HBV viral markers measured to determine if the treatment is working
Más ensayos de ALGS
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Carbamazepine | Fase 1 | En marcha, sin reclutar | jul 2025 (prevista, ya pasada: sin actualizar en el registro) |
| ALG-000184 · B-SUPREME | Fase 2 | En marcha, sin reclutar | mar 2027 (prevista) |
| Pevifoscorvir Sodium | Fase 1 | Completado | ago 2026 (real) |
| Pevifoscorvir Sodium | Fase 1 | Completado | jul 2026 (real) |
| ALG-097558 | Fase 1 | Completado | jul 2025 (real) |
| ALG-097558 | Fase 1 | Completado | jul 2025 (real) |
Todos los de ALGS, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04536337), actualizada en nov 2025.