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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Healthy

Intervention / Treatment
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* Drug: HNC042 single dose
* Drug: Placebo single dose
* Drug: HNC042 multiple ascending doses
* Drug: Placebo multiple ascending doses


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HNC042 single dose<br>HNC042,freeze-dried powder,single ascending doses Single dose, | Drug: HNC042 single dose<br>* HNC042,freeze-dried powder,single ascending doses Single dose, Intravenous route,starting dose of 100mg escalating up to 1200mg<br>|
| Placebo Comparator: Placebo single dose<br>Placebo single ascending doses , Intravenous route Single dose | Drug: Placebo single dose<br>* Placebo single ascending doses , Intravenous route Single dose, matching placebo<br>|
| Experimental: HNC042 multiple ascending doses<br>HNC042,freeze-dried powder,multiple ascending doses, Intravenous route | Drug: HNC042 multiple ascending doses<br>* HNC042,freeze-dried powder,multiple ascending doses, Intravenous route Multiple doses, daily for 7 days, anticipated doses: 300mg to 1200mg<br>|
| Placebo Comparator: Placebo, multiple ascending doses<br>Placebo, multiple ascending doses, Intravenous route, | Drug: Placebo multiple ascending doses<br>* Placebo, multiple ascending doses, Intravenous route, Multiple doses, daily for 7 days, matching placebo<br>|

What is the study measuring?
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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 |