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This is a single-center,randomized,open, single-dose, parallel-design study, which will be only enrolled Chinese healthy volunteers.
30 Chinese volunteers will be enrolled to assess the pharmacokinetic and safety of Albuvirtide in two different Administration methods. All subjects are required to collect PK blood samples before and after administration.
30 healthy subjects will be randomized into three cohorts ( cohorts A, B and C) in 1:1:1 ratio, with 10 subjects in each cohort. The subjects will receive a single dose of 320 mg of albuvirtide by iv infusion for 45 min or by iv bolus for 0.5 min or 3 min, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cohort 1: Albuvirtide | Experimental | Single dose of 320 mg by intervenous drop infusion for 45 min |
|
| cohort 2: Albuvirtide | Experimental | Single dose of 320 mg by intervenous injection for 0.5 min |
|
| cohort 3: Albuvirtide | Experimental | Single dose of 320 mg by intervenous injection for 3 min |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albuvirtide | Drug | Long-Acting HIV-1 Fusion Inhibitor (chemically modified peptide targeting HIV-1 gp41) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under curve | The area under the plase of the last measurable The area under the curve of the last measurable concentration (AUCt) | Day 0-Day 57 |
| Peak concentration | Maximum observed plasma concentration (Cmax) | Day 0-Day 57 |
| Peak time | Time to Cmax ( Tmax) | Day 0-Day 57 |
| half-time | Time for blood concentration to drop by half-time(t1/2) | Day 0-Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Incidence of Treatment-Emergent Adverse Events | Day 0-Day 63 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Anhui Medical University | Hefei | China |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C573334 | albuvirtide |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |