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C106 solution

First-in-human Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of C106 in Healthy Subjects

Ensayo de Vicore Pharma Holding AB en Safety Issues · Tolerance · Idiopathic Pulmonary Fibrosis · Pulmonary Hypertension (del registro, en inglés).

Más ensayos de: Fibrosis pulmonar idiopática · Hipertensión pulmonar.

Fase

Fase 1

Estado

Completado

Participantes

80

previstos

Centros

1

Fin del objetivo primario

jun 2023

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en jun 2022.

Qué mide

Total Number of Treatment Emergent Adverse Events (AEs) and Serious AEs (SAEs) (From date of signing informed consent until End of Study, assessed up to Day 22) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a FIH, double-blind, placebo-controlled, within-group randomised, trial designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending oral doses of compound 106 (C106) in healthy females of non-childbearing potential and healthy males. The trial will be conducted in 2 parts: Part A, single ascending dose (SAD) including a food interaction cohort: safety, tolerability, and PK in healthy males and healthy females of non-childbearing potential receiving single ascending doses of C106. Part B, multiple ascending dose (MAD): safety, tolerability, and PK in healthy males and healthy females of non-childbearing potential receiving twice daily multiple ascending doses of C106 for 8 days.

Más ensayos de VCRE

Todos los de VCRE, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05427253), actualizada en dic 2024.