NCT03567694

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

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• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Conjupro Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	HA115	Test Drug
DRUG	Placebo	Placebo

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-10-10
• Completion: 2022-10-12
• First posted: 2018-06-26
• Last updated: 2021-09-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study