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.
Overview
- Phase
- Phase 1
- Intervention
- HNC042 single dose
- Conditions
- Healthy
- Sponsor
- Guangzhou Henovcom Bioscience Co. Ltd.
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Number of subjects with adverse events
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
HNC042 single dose
HNC042,freeze-dried powder,single ascending doses Single dose,
Intervention: HNC042 single dose
Placebo single dose
Placebo single ascending doses , Intravenous route Single dose
Intervention: Placebo single dose
HNC042 multiple ascending doses
HNC042,freeze-dried powder,multiple ascending doses, Intravenous route
Intervention: HNC042 multiple ascending doses
Placebo, multiple ascending doses
Placebo, multiple ascending doses, Intravenous route,
Intervention: Placebo multiple ascending doses
Outcomes
Primary Outcomes
Number of subjects with adverse events
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- The amount of HNC042 in urine(Between Day 1 predose and 24 hours after the (last) dose)
- The amount of HNC042 in plasma(Between Day 1 predose and 24 hours after the (last) dose)