Healthy
Conditions
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.
Interventions
DRUGHNC042 single dose
HNC042,freeze-dried powder,single ascending doses Single dose, Intravenous route,starting dose of 100mg escalating up to 1200mg
Placebo single ascending doses , Intravenous route Single dose, matching placebo
DRUGHNC042 multiple ascending doses
HNC042,freeze-dried powder,multiple ascending doses, Intravenous route Multiple doses, daily for 7 days, anticipated doses: 300mg to 1200mg
DRUGPlacebo multiple ascending doses
Placebo, multiple ascending doses, Intravenous route, Multiple doses, daily for 7 days, matching placebo
Sponsors
Guangzhou Henovcom Bioscience Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 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 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed