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To evaluate the safety and tolerability of Hepalatide(L47) and characterize the clinical pharmacokinetics in healthy volunteers.
This is a randomized, double-blinded, dose escalating, phase Ib trial, which will be conducted in No. 302 Hospital of China. There are three cohorts at dose of 4.2mg, 6.3mg and 8.4mg. All healthy volunteers will be randomized into Hepalatide or placebo group at 4:1 rate, all healthy volunteers will be received treatment drug by abdominal subcutaneous injection once a day for seven days and will be observed for 3 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hepalatide | Experimental | Hepalatide 4.2mg, 6.3mg and 8.4mg |
|
| Placebo | Placebo Comparator | Placebo 4.2mg, 6.3mg and 8.4mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hepalatide | Drug | There are three cohorts as follows 4.2mg, 6.3mg, 8.4mg. At each dose level, healthy volunteers will be received treatment drug by abdominal subcutaneous injection once a day for seven days and will be monitored for 3 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Healthy participants with treatment-related adverse events as assessed by "guiding principle of grading standards for the adverse reactions in clinical trials of vaccine for prevention" or CTCAE v4.0 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) | 6 months | |
| Area under the plasma concentration versus time curve (AUC) | 6 months | |
| half-time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| zhenman wei | 302 Military Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 302 Military Hospital | Beijing | China |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D004335 | Drug and Narcotic Control |
| ID | Term |
|---|---|
| D007880 | Legislation, Drug |
| D007878 | Legislation as Topic |
| D012926 | Social Control, Formal |
| D004472 | Health Care Economics and Organizations |
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|
| Placebo | Drug | There are three cohorts as follows 4.2mg, 6.3mg, 8.4mg. At each dose level, healthy volunteers will be received control drug by abdominal subcutaneous injection once a day for seven days and will be monitored for 3 days. |
|
|
| 6 months |
| apparent volume of distribution | 6 months |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010605 | Pharmacy Administration |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |