Single and Multiple Doses of HA115 and Food Effect in Healthy Adult Volunteers

Asthma Clinical Trial

Official title: Randomized Double-Blind Placebo-controlled Ascending Dose FIH Study to Evaluate Single and Multiple Doses of HA115 in Healthy Volunteers and to Investigate Food Effect on Pharmacokinetics After Single Oral Doses of HA115

Status Withdrawn

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled Phase 1 study of HA115 capsules administered orally to healthy adult volunteers.

Clinical Trial Description

The study consists of 2 parts, Part A (SAD, including fed/fasted comparison) and Part B (MAD). Part A will be a randomized, double blind, placebo controlled, dose-escalating titration of up to 8 single dose levels of HA115. In each cohort, 8 participants will receive active compound and 2 will receive placebo in a randomized manner. Part A will include an assessment of the effect of a high-fat breakfast on the absorption and PK profile of HA115, performed in 10 participants at a single dose to be selected based on SAD results and predicted to be associated with therapeutic plasma concentrations. Part B will be a randomized, double-blind, placebo controlled parallel group study of up to 3 dose levels of HA115 given once daily. The number of days of dosing will be based on the results of the PK analysis from Part A. In each cohort, 8 participants will receive active compound fasted and 2 will receive placebo in a randomized, double blind fashion. Safety observations and PK evaluations will be made. Safety data will be reviewed with the SRC prior to each dose escalation. ;

Related Conditions & MeSH terms

• Asthma

• NCT number: NCT03567694
• Study type: Interventional
• Source: Conjupro Biotherapeutics, Inc.
• Status: Withdrawn
• Phase: Phase 1
• Start date: October 1, 2021
• Completion date: October 12, 2022