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A Randomized, Double-Blinded, Safety and Pharmacokinetic Study of Escalating Single Doses of Hepalatide in Healthy Volunteers
To evaluate the safety and tolerability of Hepalatide(L47) and characterize the clinical pharmacokinetics in healthy volunteers.
Details
| Lead sponsor | Shanghai HEP Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 35 |
| Start date | 2016-08 |
| Completion | 2016-12 |
Conditions
- Hepatitis B， Chronic
Interventions
- Hepalatide
- Placebo
Primary outcomes
- 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
Countries
China