AVT02 /ML - Healthy Volunteers | Phase 1 | Alvotech | BiopharmaWatch

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AVT02 /ML

Phase 1

Healthy Volunteers | Small molecule | Other |Alvotech|Last Updated: Jan 18, 2019

Success Probability

Approval Probability 71%

TA Base Rate26%

Adjusted LOA41%

ML RiskLOW_RISK

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Market & Valuation

rNPV $3.2B

Market Size $9.4B

Revenue Basis $1.6B

Competitors 6

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker

Total Trials1

Total Enrollment24

FDA Designations

No designations recorded

Clinical Trials (1)

NCT ID	Title	Phase	Status	Enrollment	Velocity	Design	Start	Completion	Last Updated	Sites	Countries
NCT03579823	Comparative Safety, Tolerability, Pharmacokinetic Study of AVT02 (100MG/ML) and Humira (100MG/ML) in Healthy Volunteers	PHASE1	COMPLETED	24	—	—	May 21, 2018	Aug 24, 2018	Jan 18, 2019	1	Australia

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Study Endpoints

Primary Endpoints

Change from baseline blood pressure at 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing

Predose and 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing

Measurement of blood pressure (systolic and diastolic in mm Hg)

Change from baseline heart rate at 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing

Predose and 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing

Measure of heart rate (beats per minute)

Change from baseline body temperature at 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing

Predose and 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing

Measurement of oral temperature (Celsius degree)

Change from baseline electrocardiogram at 1, 2, 5, 9, 64 days post dosing

Predose and 1, 2, 5, 9, 64 days post dosing

Analysis of 12-lead electrocardiogram

Change from baseline red blood cells at 2, 3, 5, 9, 64 days post dosing

Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure red blood cells count, (unit/mm3)

Change from baseline haemoglobin at 2, 3, 5, 9, 64 days post dosing

Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure haemoglobin (g/L)

Change from baseline white blood cells at 2, 3, 5, 9, 64 days post dosing

Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure white blood cells count, (unit/mm3)

Change from baseline platelets at 2, 3, 5, 9, 64 days post dosing

Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure platelets count, (unit/mm3)

Change from baseline blood gamma glutamyl transferase at 2, 3, 5, 9, 64 days post dosing

Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure gamma glutamyl transferase (UI/L)

Change from baseline blood aspartate aminotransferase at 2, 3, 5, 9, 64 days post

Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure aspartate aminotransferase (UI/L)

Change from baseline blood alanine aminotransferase at 2, 3, 5, 9, 64 days post

Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure alanine aminotransferase (UI/L)

Change from baseline blood potassium at 2, 3, 5, 9, 64 days post dosing

Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure potassium (mmol/L)

Change from baseline blood sodium at 2, 3, 5, 9, 64 days post dosing

Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure sodium (mmol/L)

Change from baseline blood calcium at 2, 3, 5, 9, 64 days post dosing

Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure calcium (mmol/L)

Change from baseline blood phosphate at 2, 3, 5, 9, 64 days post dosing

Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure phosphate (mmol/L)

Change from baseline blood chloride at 2, 3, 5, 9, 64 days post dosing

Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure chloride (mmol/L)

Change from baseline blood bicarbonate at 2, 3, 5, 9, 64 days post dosing

Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure bicarbonate (mmol/L)

Change from baseline blood creatinine at 2, 3, 5, 9, 64 days post dosing

Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure creatinine (micromol/L)

Change from baseline blood bilirubin at 2, 3, 5, 9, 64 days post dosing

Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure Bilirubin (micromol/L)

Change from baseline international normalised ratio at 2, 3, 5, 9, 64 days post dosing

Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure international normalised ratio

Change from baseline prothrombin time at 2, 3, 5, 9, 64 days post dosing

Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure prothrombin time (sec)

Change from baseline partial prothrombin time at 2, 3, 5, 9, 64 days post dosing

Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure partial prothrombin time (sec)

Change from baseline activated partial thromboplastin time at 2, 3, 5, 9, 64 days post

Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure activated partial thromboplastin time (sec)

Change from baseline thrombin time at 2, 3, 5, 9, 64 days post

Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure thrombin time (sec)

Change from baseline urine leucocytes at 2, 3, 5, 9, 64 days post dosing

Predose and 2, 3, 5, 9, 64 days post dosing

Urine sample collection to measure leucocytes

Change from baseline urine glucose at 2, 3, 5, 9, 64 days post dosing

Predose and 2, 3, 5, 9, 64 days post dosing

Urine sample collection to measure glucose

Change from baseline urine protein at 2, 3, 5, 9, 64 days post dosing

Predose and 2, 3, 5, 9, 64 days post dosing

Urine sample collection to measure protein

Secondary Endpoints

Area under the plasma concentration-time curve (AUC)

Over 64 days

Maximum serum concentration

Over 64 days

Time to maximum serum concentration

Over 64 days

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Study Design & Arms

AllocationRANDOMIZED

MaskingSINGLE

ModelPARALLEL

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
AVT02 100 MG/ML	EXPERIMENTAL	Single subcutaneous injection of 40 mg of AVT02 (100MG/ML)
Adalimumab 100 MG/ML [HUMIRA]	ACTIVE_COMPARATOR	Single subcutaneous injection of 40 mg of Adalimumab (100MG/ML) \[HUMIRA\]

Interventions

Name	Type	Description
Adalimumab 100 MG/ML [Humira]	DRUG	prefilled syringe at a concentration of 100MG/ML and delivering 40MG of adalimumab, as a single dose on day 1 day 1
AVT02 100MG/ML	DRUG	prefilled syringe at a concentration of 100MG/ML delivering 40MG of AVT02, as a single dose on day 1 day 1

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Eligibility Criteria

Age Range18 Years — 55 Years

SexALL

Healthy VolunteersYes

Study Sites1

Main Inclusion Criteria: * Male and female healthy adult subjects willing to sign an Informed Consent Form and able to undergo protocol related procedures. * Age: 18 to 55 years, inclusive. * Body Mass Index (BMI): 19.0 to 30.0 kg per m2. * Medical history without major pathology, at the discretion...

Countries:Australia

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