NCT03740555

A Study of HNC042 in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics.

A Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Single and Multiple Ascending Doses (SAD/MAD) Study Following Intravenous Administration in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of HNC042.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Guangzhou Henovcom Bioscience Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this First-in-Human study is to evaluate the safety , tolerability and pharmacokinetics after single ascending of HNC042 given to healthy subjects, compared to placebo. Also, the safety , tolerability and pharmacokinetics of multiple ascending of HNC042 given to healthy subjects daily for 7 days compared to placebo , will be evaluated.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HNC042 single dose	HNC042,freeze-dried powder,single ascending doses Single dose, Intravenous route,starting dose of 100mg escalating up to 1200mg
DRUG	Placebo single dose	Placebo single ascending doses , Intravenous route Single dose, matching placebo
DRUG	HNC042 multiple ascending doses	HNC042,freeze-dried powder,multiple ascending doses, Intravenous route Multiple doses, daily for 7 days, anticipated doses: 300mg to 1200mg
DRUG	Placebo multiple ascending doses	Placebo, multiple ascending doses, Intravenous route, Multiple doses, daily for 7 days, matching placebo

Timeline

• Start date: 2018-11-09
• Primary completion: 2019-07-19
• Completion: 2019-07-19
• First posted: 2018-11-14
• Last updated: 2019-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study