Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Vir Biotechnology, Inc. | INDUSTRY |
| Alnylam Pharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
This study is to evaluate the safety, pharmacokinetics characteristics, and antiviral activities of multiple doses of VIR-2218 in adults with chronic HBV infection in mainland China.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIR-2218 | Experimental | Drug: VIR-2218 VIR-2218 given by subcutaneous injection |
|
| Placebo | Placebo Comparator | Drug: Placebo Saline given by subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIR-2218 | Drug | VIR-2218 given by subcutaneous injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-emergent Adverse Events (TEAEs) | Number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0 are summarized by cohort. Incidence is defined as the number of participants with TEAEs in relation to the total number of participants in the cohort. TEAEs are defined as any AEs with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug. | up to 48 weeks |
| Clinical Assessments Including But Not Limited to Laboratory Test Results | Number of participants with graded hematology, coagulation, chemistry abnormalities, and clinically significant abnormalities in vital signs and ECGs | up to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PK: Maximum Plasma Concentration | VIR-2218 and metabolite maximum plasma concentrations (ng/mL) VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24. | Maximum plasma concentrations were calculated based on all above results for Day 1 and Day 29 (Week 4). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xiaofei Chen | Brii Biosciences Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Beijing | Beijing Municipality | China | |||
| Investigative Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: VIR-2218 50 mg | HBeAg negative, participants received 2 SC doses of VIR-2218 50 mg administered 4 weeks apart |
| FG001 | Part 1: VIR-2218 100 mg | HBeAg negative, participants received 2 SC doses of VIR-2218 100 mg administered 4 weeks apart |
| FG002 | Part 1: Placebo | HBeAg negative, participants received 2 SC doses of placebo administered 4 weeks apart |
| FG003 | Part 2: VIR-2218 50mg | HBeAg positive, participants received 2 SC doses of VIR-2218 50 mg administered 4 weeks apart |
| FG004 | Part 2: VIR-2218 100 mg | HBeAg positive, participants received 2 SC doses of VIR-2218 100 mg administered 4 weeks apart |
| FG005 | Part 2: Placebo | HBeAg positive, participants received 2 SC doses of placebo administered 4 weeks apart |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: VIR-2218 50 mg | HBeAg negative, participants received 2 SC doses of VIR-2218 50 mg administered every 4 weeks apart |
| BG001 | Part 1: VIR-2218 100 mg | HBeAg negative, participants received 2 SC doses of VIR-2218 100 mg administered every 4 weeks apart |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Treatment-emergent Adverse Events (TEAEs) | Number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0 are summarized by cohort. Incidence is defined as the number of participants with TEAEs in relation to the total number of participants in the cohort. TEAEs are defined as any AEs with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug. | All randomized participants who received at least 1 dose of study drug | Posted | Count of Participants | Participants | up to 48 weeks |
|
Up to 48 weeks after the first dose of VIR-2218 or placebo
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1: VIR-2218 50 mg | HBeAg negative, participants received 2 SC doses of VIR-2218 50 mg administered every 4 weeks apart |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research | Brii Biosciences Limited | 86 10 6299 8808 | clinicaltrials@briibio.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 23, 2020 | Jul 2, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 19, 2021 | Jul 2, 2024 | SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006509 | Hepatitis B |
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Saline given by subcutaneous injection |
|
| PK: Time to Reach Maximum Plasma Concentration | VIR-2218 and metabolite time to Cmax (h) VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24. | Time to Cmax were calculated based on all above results for Day 1 and Day 29 (Week 4). |
| PK: Area Under the Plasma Concentration Versus Time Curve to Last Measurable Timepoint | VIR-2218 and metabolite area under the curve from time 0 to last measurable time (ng*h/mL) VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24. | Area under the curve were calculated based on all above results for Day 1 and Day 29 (Week 4). |
| PK: Area Under the Plasma Concentration Versus Time Curve to Infinity | VIR-2218 and metabolite area under the curve from time 0 to infinity (ng*h/mL) VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24. | Area under the curve were calculated based on all above results for Day 1 and Day 29 (Week 4). |
| PK: Percent of Area Extrapolated From AUC Last to Infinity | VIR-2218 and metabolite percent of area extrapolated from AUC last to infinity (%) VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24. | Percent of area extrapolated from AUC last to infinity were calculated based on all above results for Day 1 and Day 29 (Week 4). |
| PK: Apparent Terminal Elimination Half-life | VIR-2218 and metabolite apparent terminal elimination half-life (h) VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24. | Apparent terminal elimination half-life were calculated based on all above results for Day 1 and Day 29 (Week 4). |
| PK: Apparent Plasma Clearance | VIR-2218 and metabolite apparent plasma clearance CL/F (mL/h) VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24. | Apparent plasma clearance were calculated based on all above results for Day 1 and Day 29 (Week 4). |
| PK: Apparent Volume of Distribution | VIR-2218 and metabolite apparent volume of distribution Vz/F (mL) VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24. | Apparent volume of distribution were calculated based on all above results for Day 1 and Day 29 (Week 4). |
| Maximum Change of Serum HBsAg From Baseline | Maximum change of serum HBsAg from Day 1 until 12 weeks post last dose (negative values mean reductions from baseline, positive values mean increased from baseline) | up to 16 weeks |
| Number of Participants With Serum HBsAg Loss | Number of participants with serum HBsAg < 0.05 IU/mL at two or more consecutive measurements | up to 48 weeks |
| Number of Participants With Sustained Serum HBsAg Loss for at Least 6 Months | Number of participants with sustained serum HBsAg < 0.05 IU/mL at all visits for at least 6 months | up to 48 weeks |
| Number of Participants With Anti-HBs Seroconversion at Any Timepoint | Anti-HBs seroconversion is defined as anti-HBs positivity at two or more consecutive measurements | up to 48 weeks |
| For HBeAg-positive Subjects: Number of Subjects With HBeAg Loss and/or Anti-HBe Seroconversion at Any Timepoint | HBeAg loss is defined as quantitative HBeAg < 0.14 IU/mL at two or more consecutive measurements. Anti-HBe seroconversion is defined as anti-HBe positivity at two or more consecutive measurements. | up to 48 weeks |
| Changchun |
| Jilin |
| China |
| Lost to Follow-up |
|
| BG002 | Part 1: Placebo | HBeAg negative, participants received 2 SC doses of placebo administered every 4 weeks apart |
| BG003 | Part 2: VIR-2218 50 mg | HBeAg positive, participants received 2 SC doses of VIR-2218 50 mg administered every 4 weeks apart |
| BG004 | Part 2: VIR-2218 100 mg | HBeAg positive, participants received 2 SC doses of VIR-2218 100 mg administered every 4 weeks apart |
| BG005 | Part 2: Placebo | HBeAg positive, participants received 2 SC doses of placebo administered every 4 weeks apart |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline log10 hepatitis B surface antigen | Mean | Standard Deviation | log10 IU/mL |
|
| Part 1: VIR-2218 100 mg |
HBeAg negative, participants received 2 SC doses of VIR-2218 100 mg administered every 4 weeks apart |
| OG002 | Part 1: Placebo | HBeAg negative, participants received 2 SC doses of placebo administered every 4 weeks apart |
| OG003 | Part 2: VIR-2218 50 mg | HBeAg positive, participants received 2 SC doses of VIR-2218 50 mg administered every 4 weeks apart |
| OG004 | Part 2: VIR-2218 100 mg | HBeAg positive, participants received 2 SC doses of VIR-2218 100 mg administered every 4 weeks apart |
| OG005 | Part 2: Placebo | HBeAg positive, participants received 2 SC doses of placebo administered every 4 weeks apart |
|
|
| Primary | Clinical Assessments Including But Not Limited to Laboratory Test Results | Number of participants with graded hematology, coagulation, chemistry abnormalities, and clinically significant abnormalities in vital signs and ECGs | All randomized participants who received at least 1 dose of study drug | Posted | Count of Participants | Participants | up to 48 weeks |
|
|
|
| Secondary | PK: Maximum Plasma Concentration | VIR-2218 and metabolite maximum plasma concentrations (ng/mL) VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24. | All randomized participants who received at least 1 dose of VIR-2218 and had 1 post-baseline PK parameter | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Maximum plasma concentrations were calculated based on all above results for Day 1 and Day 29 (Week 4). |
|
|
|
| Secondary | PK: Time to Reach Maximum Plasma Concentration | VIR-2218 and metabolite time to Cmax (h) VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24. | All randomized participants who received at least 1 dose of VIR-2218 and had 1 post-baseline PK parameter | Posted | Median | Full Range | hour | Time to Cmax were calculated based on all above results for Day 1 and Day 29 (Week 4). |
|
|
|
| Secondary | PK: Area Under the Plasma Concentration Versus Time Curve to Last Measurable Timepoint | VIR-2218 and metabolite area under the curve from time 0 to last measurable time (ng*h/mL) VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24. | All randomized participants who received at least 1 dose of VIR-2218 and had 1 post-baseline PK parameter | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Area under the curve were calculated based on all above results for Day 1 and Day 29 (Week 4). |
|
|
|
| Secondary | PK: Area Under the Plasma Concentration Versus Time Curve to Infinity | VIR-2218 and metabolite area under the curve from time 0 to infinity (ng*h/mL) VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24. | All randomized participants who received at least 1 dose of VIR-2218 and had 1 post-baseline PK parameter | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Area under the curve were calculated based on all above results for Day 1 and Day 29 (Week 4). |
|
|
|
| Secondary | PK: Percent of Area Extrapolated From AUC Last to Infinity | VIR-2218 and metabolite percent of area extrapolated from AUC last to infinity (%) VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24. | All randomized participants who received at least 1 dose of VIR-2218 and had 1 post-baseline PK parameter | Posted | Geometric Mean | Geometric Coefficient of Variation | % of AUCinf | Percent of area extrapolated from AUC last to infinity were calculated based on all above results for Day 1 and Day 29 (Week 4). |
|
|
|
| Secondary | PK: Apparent Terminal Elimination Half-life | VIR-2218 and metabolite apparent terminal elimination half-life (h) VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24. | All randomized participants who received at least 1 dose of VIR-2218 and had 1 post-baseline PK parameter | Posted | Median | Full Range | hour | Apparent terminal elimination half-life were calculated based on all above results for Day 1 and Day 29 (Week 4). |
|
|
|
| Secondary | PK: Apparent Plasma Clearance | VIR-2218 and metabolite apparent plasma clearance CL/F (mL/h) VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24. | All randomized participants who received at least 1 dose of VIR-2218 and had 1 post-baseline PK parameter | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/h | Apparent plasma clearance were calculated based on all above results for Day 1 and Day 29 (Week 4). |
|
|
|
| Secondary | PK: Apparent Volume of Distribution | VIR-2218 and metabolite apparent volume of distribution Vz/F (mL) VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24. | All randomized participants who received at least 1 dose of VIR-2218 and had 1 post-baseline PK parameter | Posted | Geometric Mean | Geometric Coefficient of Variation | mL | Apparent volume of distribution were calculated based on all above results for Day 1 and Day 29 (Week 4). |
|
|
|
| Secondary | Maximum Change of Serum HBsAg From Baseline | Maximum change of serum HBsAg from Day 1 until 12 weeks post last dose (negative values mean reductions from baseline, positive values mean increased from baseline) | All randomized participants who received at least 1 dose of study drug and had at least 1 non-missing data for antiviral parameters | Posted | Mean | Standard Deviation | log10 IU/mL | up to 16 weeks |
|
|
|
| Secondary | Number of Participants With Serum HBsAg Loss | Number of participants with serum HBsAg < 0.05 IU/mL at two or more consecutive measurements | All randomized participants who received at least 1 dose of study drug and had at least 1 non-missing data for antiviral parameters | Posted | Count of Participants | Participants | up to 48 weeks |
|
|
|
| Secondary | Number of Participants With Sustained Serum HBsAg Loss for at Least 6 Months | Number of participants with sustained serum HBsAg < 0.05 IU/mL at all visits for at least 6 months | All randomized participants who received at least 1 dose of study drug and had at least 1 non-missing data for antiviral parameters | Posted | Count of Participants | Participants | up to 48 weeks |
|
|
|
| Secondary | Number of Participants With Anti-HBs Seroconversion at Any Timepoint | Anti-HBs seroconversion is defined as anti-HBs positivity at two or more consecutive measurements | All randomized participants who received at least 1 dose of study drug and had at least 1 non-missing data for antiviral activity parameter | Posted | Count of Participants | Participants | up to 48 weeks |
|
|
|
| Secondary | For HBeAg-positive Subjects: Number of Subjects With HBeAg Loss and/or Anti-HBe Seroconversion at Any Timepoint | HBeAg loss is defined as quantitative HBeAg < 0.14 IU/mL at two or more consecutive measurements. Anti-HBe seroconversion is defined as anti-HBe positivity at two or more consecutive measurements. | Part 2 (HBeAg positive) participants only; all randomized participants who received at least 1 dose of study drug and had at least 1 non-missing data for antiviral activity parameter | Posted | Count of Participants | Participants | up to 48 weeks |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 1 |
| 4 |
| EG001 | Part 1: VIR-2218 100 mg 100 mg | HBeAg negative, participants received 2 SC doses of VIR-2218 100 mg administered every 4 weeks apart | 0 | 4 | 0 | 4 | 2 | 4 |
| EG002 | Part 1: Placebo | HBeAg negative, participants received 2 SC doses of placebo administered every 4 weeks apart | 0 | 3 | 0 | 3 | 0 | 3 |
| EG003 | Part 2: VIR-2218 50 mg | HBeAg positive, participants received 2 SC doses of VIR-2218 50 mg administered every 4 weeks apart | 0 | 4 | 0 | 4 | 2 | 4 |
| EG004 | Part 2: VIR-2218 100 mg | HBeAg positive, participants received 2 SC doses of VIR-2218 100 mg administered every 4 weeks apart | 0 | 4 | 0 | 4 | 1 | 4 |
| EG005 | Part 2: Placebo | HBeAg positive, participants received 2 SC doses of placebo administered every 4 weeks apart | 0 | 2 | 0 | 2 | 1 | 2 |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Systematic Assessment |
|
Investigator will submit the proposed publication to sponsor at least 60 days prior to submission to a publisher.
Sponsor shall advise investigator any information that are confidential or may impair the availability of patent protection for study inventions.
Sponsor may require to remove confidential information and/or to delay the proposed publication or presentation for an additional 60 days to seek patent protection for study inventions.
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Any post baseline laboratory abnormalities of CTCAE Grade 2 or above |
|
| Any clinically significant vital signs |
|
| Any clinically significant ECGs |
|
|
| VIR-2218 Cmax (Day 29) |
|
|
| AS(N-1)3'VIR-2218 Cmax (Day 1) |
|
|
| AS(N-1)3'VIR-2218 Cmax (Day 29) |
|
|
|
| VIR-2218 Tmax (Day 29) |
|
|
| AS(N-1)3'VIR-2218 Tmax (Day 1) |
|
|
| AS(N-1)3'VIR-2218 Tmax (Day 29) |
|
|
|
| VIR-2218 AUClast (Day 29) |
|
|
| AS(N-1)3'VIR-2218 AUClast (Day 1) |
|
|
| AS(N-1)3'VIR-2218 AUClast (Day 29) |
|
|
|
| VIR-2218 AUCinf (Day 29) |
|
|
| AS(N-1)3'VIR-2218 AUCinf (Day 1) |
|
| AS(N-1)3'VIR-2218 AUCinf (Day 29) |
|
|
| VIR-2218 %AUCextrap (Day 29) |
|
|
| AS(N-1)3'VIR-2218 %AUCextrap (Day 1) |
|
| AS(N-1)3'VIR-2218 %AUCextrap (Day 29) |
|
|
|
| VIR-2218 t1/2 (Day 29) |
|
|
| AS(N-1)3'VIR-2218 t1/2 (Day 1) |
|
| AS(N-1)3'VIR-2218 t1/2 (Day 29) |
|
|
| VIR-2218 CL/F (Day 29) |
|
|
| AS(N-1)3'VIR-2218 CL/F (Day 1) |
|
| AS(N-1)3'VIR-2218 CL/F (Day 29) |
|
|
| VIR-2218 Vz/F (Day 29) |
|
|
| AS(N-1)3'VIR-2218 Vz/F (Day 1) |
|
| AS(N-1)3'VIR-2218 Vz/F (Day 29) |
|
| Title | Measurements |
|---|---|
|