drugset / Trial / NCT04104399

Single Ascending Dose Study to Investigate the Safety and Pharmacokinetics of XC101-D13H in Healthy Adult Subjects

NCT04104399 ↗

Phase 1 Unknown 32 enrolled Xoc Pharmaceuticals
RandomizedSequentialQuadruple-blindTreatment

Summary

This is a randomized, double-blind, placebo-controlled, parallel-group single ascending dose (SAD) study. There are 4 cohorts of 8 subjects (8 active and 2 placebo) planned for evaluation under fasting conditions. One of the planned dose levels will cross over after a washout period to receive the same single dose of XC101-D13H or placebo under fed conditions.

Timeline

Start
2019-10-08
Primary completion
2022-01-28
Completion
2022-03-30

Drugs

EvaluationDrugModalityDoseRoute
Subject XC101-D13H Unknown 0.4 mg —
Subject XC101-D13H Unknown 0.8 mg —
Subject XC101-D13H Unknown 1.6 mg —
Subject XC101-D13H Unknown 3.2 mg —

Indications