drugset / Trial / NCT04458805

Safety, Tolerability and Pharmacokinetics of Oral NX-13 in Healthy Adults Male and Female Volunteers

NCT04458805 ↗

Phase 1 Completed 56 enrolled Landos Biopharma Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort study. The study will be conducted in 2 parts: a single ascending dose (SAD) part (Part A) followed by a multiple ascending dose (MAD) part (Part B). The decision to escalate between dose levels and proceed to Part B will be based upon review of blinded available safety data by a Safety Review Committee.

Timeline

Start
2020-07-10
Primary completion
2020-10-21
Completion
2020-10-21

Drugs

EvaluationDrugModalityDoseRoute
Subject NX-13 Unknown 250 mg Oral

Indications