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.

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: HNC042 single dose; Drug: Placebo single dose; Drug: HNC042 multiple ascending doses; Drug: Placebo multiple ascending doses

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Paolo B. DePetrillo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HNC042 single dose; HNC042,freeze-dried powder,single ascending doses Single dose,	Drug: HNC042 single dose; HNC042,freeze-dried powder,single ascending doses Single dose, Intravenous route,starting dose of 100mg escalating up to 1200mg
Placebo Comparator: Placebo single dose; Placebo single ascending doses , Intravenous route Single dose	Drug: Placebo single dose; Placebo single ascending doses , Intravenous route Single dose, matching placebo
Experimental: HNC042 multiple ascending doses; HNC042,freeze-dried powder,multiple ascending doses, Intravenous route	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
Placebo Comparator: Placebo, multiple ascending doses; Placebo, multiple ascending doses, Intravenous route,	Drug: Placebo multiple ascending doses; Placebo, multiple ascending doses, Intravenous route, Multiple doses, daily for 7 days, matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with adverse events	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	Between screening and 7 days after the last dose
Number of subjects with abnormal laboratory	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	Between screening and 7days after the last dose
Number of subjects with abnormal electrocardiogram	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	Between screening and 7 days after the last dose
Number of subjects with abnormal physical examination	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	Between screening and 7 days after the last dose
Number of subjects with abnormal vital signs	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	Between screening and 7 days after the last dose

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Guangzhou Henovcom Bioscience Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2018
• Primary Completion (Actual): July 19, 2019
• Study Completion (Actual): July 19, 2019

Study Registration Dates

• First Submitted: November 9, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Actual): September 19, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: HNC042-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No