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Single doses of ARC-520 will be evaluated at varying infusion rates and by slow bolus push.
This is a single-center, open-label, sequential cohort, single-dose study of ARC-520 administered intravenously to healthy adult volunteers. Eligible subjects will receive a single intravenous injection of ARC-520. Up to 8 cohorts (a total of approximately 40 subjects) may be enrolled. ARC-520 (4.0 mg/kg) will be administered at increasing infusion rates up to a bolus push in cohort 5. In addition dose levels at 5.0 mg/kg and 6.0 mg/kg will be evaluated at an infusion rate of 0.9 mL/min. For each subject the duration of the study clinic visits is approximately 6 weeks; maximum study duration is approximately 17 weeks including follow-up telephone calls at Days 30, 60 and 90.
Participants will undergo the following evaluations at regular intervals: medical history, physical examinations, bee venom allergy blood test, vital signs measurements, weight, adverse event monitoring, electrocardiograms (ECGs), telemetry, pregnancy test (females), concurrent medication, blood sample collection for hematology, coagulation, chemistry, pharmacokinetics, pharmacodynamics, and drug screens, and urinalysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARC-520 Cohort 1 | Experimental | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine |
|
| ARC-520 Cohort 2A | Experimental | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine |
|
| ARC-520 Cohort 2 | Experimental | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine |
|
| ARC-520 Cohort 3 | Experimental | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine |
|
| ARC-520 Cohort 4 | Experimental | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine |
|
| ARC-520 Cohort 5 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARC-520 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) is defined as any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. TEAEs were defined as all AEs starting or worsening after commencement of treatment with investigational product. | post-dose through the end of study (Day 15 ± 1 day) plus 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24) of the Analytes of ARC-520 | Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting hepatitis B virus [HBV]) and melittin-like peptide (MLP). | Day 1 pre-dose through 48 hours post-dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site 1 | Herston | Queensland | 4029 | Australia |
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| ID | Title | Description |
|---|---|---|
| FG000 | ARC-520 Cohort 1 | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine |
| FG001 | ARC-520 Cohort 2A | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine |
| FG002 | ARC-520 Cohort 2 | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine |
| FG003 | ARC-520 Cohort 3 | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine |
| FG004 | ARC-520 Cohort 4 | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine |
| FG005 | ARC-520 Cohort 5 | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine |
| FG006 | ARC-520 Cohort 6 | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine |
| FG007 | ARC-520 Cohort 7 | Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine |
| FG008 | ARC-520 Cohort 8 | Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ARC-520 Cohort 1 | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine |
| BG001 | ARC-520 Cohort 2A | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine |
| 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 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) is defined as any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. TEAEs were defined as all AEs starting or worsening after commencement of treatment with investigational product. | Safety Population: all enrolled participants | Posted | Number | participants | post-dose through the end of study (Day 15 ± 1 day) plus 30 days |
|
post-dose through the end of study (Day 15 ± 1 day) plus 30 days
TEAEs are presented, defined as all AEs starting or worsening after commencement of treatment with investigational product.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ARC-520 Cohort 1 | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Hamilton, MD | Arrowhead Pharmaceuticals, Inc. | 626-696-3400 | jhamilton@arrowheadpharma.com |
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| ID | Term |
|---|---|
| C000717093 | ARC-520 |
| D017332 | Cetirizine |
| D004155 | Diphenhydramine |
| ID | Term |
|---|---|
| D006919 | Hydroxyzine |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Experimental |
Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine |
|
| ARC-520 Cohort 6 | Experimental | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine |
|
| ARC-520 Cohort 7 | Experimental | Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine |
|
| ARC-520 Cohort 8 | Experimental | Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine |
|
| cetirizine | Drug |
|
| diphenhydramine | Drug |
|
| Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast) of the Analytes of ARC-520 |
Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP. |
| Day 1 pre-dose through 48 hours post-dose |
| Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From Zero Extrapolated to Infinity (AUCinf) of the Analytes of ARC-520 | Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP. | Day 1 pre-dose through 48 hours post-dose |
| Pharmacokinetics: Maximum Plasma Concentration (Cmax) of the Analytes of ARC-520 | Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP. | Day 1 pre-dose through 48 hours post-dose |
| Pharmacokinetics: Clearance (CL) of the Analytes of ARC-520 | Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP. | Day 1 pre-dose through 48 hours post-dose |
| Pharmacokinetics: Apparent Volume of Distribution (V) of the Analytes of ARC-520 | Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP. | Day 1 pre-dose through 48 hours post-dose |
| Pharmacokinetics: Terminal Elimination Rate Constant (Lambda z) of the Analytes of ARC-520 | Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP. | Day 1 pre-dose through 48 hours post-dose |
| Pharmacokinetics: Half-Life (t1/2) of the Analytes of ARC-520 | Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP. | Day 1 pre-dose through 48 hours post-dose |
| BG002 | ARC-520 Cohort 2 | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine |
| BG003 | ARC-520 Cohort 3 | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine |
| BG004 | ARC-520 Cohort 4 | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine |
| BG005 | ARC-520 Cohort 5 | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine |
| BG006 | ARC-520 Cohort 6 | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine |
| BG007 | ARC-520 Cohort 7 | Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine |
| BG008 | ARC-520 Cohort 8 | Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine |
| BG009 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | ARC-520 Cohort 2 | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine |
| OG003 | ARC-520 Cohort 3 | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine |
| OG004 | ARC-520 Cohort 4 | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine |
| OG005 | ARC-520 Cohort 5 | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine |
| OG006 | ARC-520 Cohort 6 | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine |
| OG007 | ARC-520 Cohort 7 | Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine |
| OG008 | ARC-520 Cohort 8 | Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine |
|
|
| Secondary | Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24) of the Analytes of ARC-520 | Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting hepatitis B virus [HBV]) and melittin-like peptide (MLP). | All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one pharmacokinetic (PK) sample collected | Posted | Mean | Standard Deviation | ng.hr/mL | Day 1 pre-dose through 48 hours post-dose |
|
|
|
| Secondary | Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast) of the Analytes of ARC-520 | Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP. | All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one PK sample collected | Posted | Mean | Standard Deviation | ng.hr/mL | Day 1 pre-dose through 48 hours post-dose |
|
|
|
| Secondary | Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From Zero Extrapolated to Infinity (AUCinf) of the Analytes of ARC-520 | Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP. | All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one PK sample collected | Posted | Mean | Standard Deviation | ng.hr/mL | Day 1 pre-dose through 48 hours post-dose |
|
|
|
| Secondary | Pharmacokinetics: Maximum Plasma Concentration (Cmax) of the Analytes of ARC-520 | Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP. | All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one PK sample collected | Posted | Mean | Standard Deviation | ng/mL | Day 1 pre-dose through 48 hours post-dose |
|
|
|
| Secondary | Pharmacokinetics: Clearance (CL) of the Analytes of ARC-520 | Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP. | All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one PK sample collected | Posted | Mean | Standard Deviation | mL/hr/kg | Day 1 pre-dose through 48 hours post-dose |
|
|
|
| Secondary | Pharmacokinetics: Apparent Volume of Distribution (V) of the Analytes of ARC-520 | Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP. | All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one PK sample collected | Posted | Mean | Standard Deviation | mL/kg | Day 1 pre-dose through 48 hours post-dose |
|
|
|
| Secondary | Pharmacokinetics: Terminal Elimination Rate Constant (Lambda z) of the Analytes of ARC-520 | Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP. | All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one PK sample collected | Posted | Mean | Standard Deviation | 1/hr | Day 1 pre-dose through 48 hours post-dose |
|
|
|
| Secondary | Pharmacokinetics: Half-Life (t1/2) of the Analytes of ARC-520 | Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP. | All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one PK sample collected | Posted | Mean | Standard Deviation | hour | Day 1 pre-dose through 48 hours post-dose |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 2 |
| 4 |
| EG001 | ARC-520 Cohort 2A | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine | 0 | 2 | 0 | 2 | 2 | 2 |
| EG002 | ARC-520 Cohort 2 | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine | 0 | 4 | 0 | 4 | 1 | 4 |
| EG003 | ARC-520 Cohort 3 | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine | 0 | 4 | 0 | 4 | 3 | 4 |
| EG004 | ARC-520 Cohort 4 | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine | 0 | 4 | 0 | 4 | 3 | 4 |
| EG005 | ARC-520 Cohort 5 | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine | 0 | 4 | 0 | 4 | 2 | 4 |
| EG006 | ARC-520 Cohort 6 | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine | 0 | 6 | 0 | 6 | 5 | 6 |
| EG007 | ARC-520 Cohort 7 | Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine | 0 | 6 | 0 | 6 | 3 | 6 |
| EG008 | ARC-520 Cohort 8 | Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine | 0 | 6 | 0 | 6 | 2 | 6 |
| Ocular hyperaemia | Eye disorders | MedDRA 19.0 | Systematic Assessment |
|
| Abdomial discomfort | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| General symptom | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Injection site pustule | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
|
| Aspartate aminotrasferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
|
| Peripheral coldness | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
|
Not provided
Not provided
| D005021 |
| Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Analyte AD0010 |
|
| Analyte MLP |
|
| Analyte AD0010 |
|
| Analyte MLP |
|
| Analyte AD0010 |
|
| Analyte MLP |
|
| Analyte AD0010 |
|
| Analyte MLP |
|
| Analyte AD0010 |
|
| Analyte MLP |
|
| Analyte AD0010 |
|
| Analyte MLP |
|
| Analyte AD0010 |
|
| Analyte MLP |
|
| Analyte AD0010 |
|
| Analyte MLP |
|