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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo multiple ascending doses; Drug: HNC042 single dose; Drug: HNC042 multiple ascending doses; Drug: Placebo single dose

• Registration Number: NCT03740555
• Lead Sponsor: Guangzhou Henovcom Bioscience Co. Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-09
• Study First Submitted: 2018-11-09
• Study First Submitted QC: 2018-11-09
• Study First Posted: 2018-11-14
• Primary Completion: 2019-07-19
• Study Completion: 2019-07-19
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-18
• Last Update Posted: 2019-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• Healthy volunteer, age 18-56 years
• BMI between 18-34 kg/m2,and body weight not less than 50.0kg.

Exclusion Criteria

• Any condition that might interfere with the procedures or tests in this study
• Drug or alcohol abuse
• Smoking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo, multiple ascending doses	Placebo multiple ascending doses	Placebo, multiple ascending doses, Intravenous route,
HNC042 single dose	HNC042 single dose	HNC042,freeze-dried powder,single ascending doses Single dose,
HNC042 multiple ascending doses	HNC042 multiple ascending doses	HNC042,freeze-dried powder,multiple ascending doses, Intravenous route
Placebo single dose	Placebo single dose	Placebo single ascending doses , Intravenous route Single dose

Primary Outcome Measures

Name	Time	Method
Number of subjects with adverse events	Between screening and 7 days after the last dose	To evaluate the safety and tolerability of HNC042 in comparison with placebo after a single and multiple intravenous dose in healthy subjects in terms of adverse events
Number of subjects with abnormal laboratory	Between screening and 7days after the last dose	To evaluate the safety and tolerability of HNC042 in comparison with placebo after single and multiple intravenous dose in healthy subjects in terms of abnormal laboratory
Number of subjects with abnormal electrocardiogram	Between screening and 7 days after the last dose	To evaluate the safety and tolerability of HNC042 in comparison with placebo after a single and multiple intravenous dose in healthy subjects in terms of abnormal electrocardiogram
Number of subjects with abnormal vital signs	Between screening and 7 days after the last dose	To evaluate the safety and tolerability of HNC042 in comparison with placebo after a single and multiple intravenous dose in healthy subjects in terms of abnormal vital signs
Number of subjects with abnormal physical examination	Between screening and 7 days after the last dose	To evaluate the safety and tolerability of HNC042 in comparison with placebo after a single and multiple intravenous dose in healthy subjects in terms of abnormal physical examination

Secondary Outcome Measures

Name	Time	Method
The amount of HNC042 in urine	Between Day 1 predose and 24 hours after the (last) dose	To characterize the amount of HNC042 in urine over time - pharmacokinetics (PK) - after a single and multiple intravenous dose in healthy subjects
The amount of HNC042 in plasma	Between Day 1 predose and 24 hours after the (last) dose	To characterize the amount of HNC042 in plasma over time - pharmacokinetics (PK) - after a single and multiple intravenous dose in healthy subjects

Trial Locations

Locations (1)

Paolo B. DePetrillo; 🇺🇸 Baltimore, Maryland, United States