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TA-46

Phase 1

Healthy | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: Jun 1, 2020

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
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment78
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04410809Study Of Safety, Tolerability And Pharmacokinetics Of Subcutaneous Doses Of TA-46PHASE1 COMPLETED 78Jan 19, 2018Nov 27, 2019Jun 1, 20201 Netherlands
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Study Endpoints
Primary Endpoints
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Bsseline to Day 43 after last dose of study medication

Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Y days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug X was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.

Number of Participants With Clinical Laboratory Abnormalities
Baseline up to Day 43 after last dose of study medication

Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, lactate dehydrogenase, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, phosphate, bicarbonate); clinical chemistry (glucose, creatine kinase); immunology (CRP); urinalysis (dipstick \[urine specific gravity, decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin\], microscopy \[urine RBC, WBC, urate crystals, calcium, oxalate, miscellaneous \[urine mucus and leucocytes\]).

Incidence of Anti-Drug Antibody (ADA)
Baselin up to Day 43 after last dose of study medication

The percentage of participants with positive ADA and neutralizing antibodies will be summarized for each treatment arm.

Number of Participants With Change From Baseline in Physical Examinations and Vital Signs
Baseline up to Day 43 after last dose study medication

Number of participants with potentially clinically important (PCI) physical examinations and vital signs is reported during therapy and at post therapy. Criteria for PCI change in vital signs: heart rate value of \<40 beats per minute and value \>150 beats per minute, systolic blood pressure (SBP) of \<80 or \>210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of \<40 or \>130 mmHg, temperature \<32 or \>40 degree centigrade, respiratory rate of \<10 or \>50 breaths/minute and criteria for PCI change in physical examination: \>=10% increase or decrease of body weight in kilogram (kg).

Number of Participants With Abnormal Electrocardiogram (ECG)
Baseline up to Day 22 after last dose of study medication

Criteria for ECG abnormalities: maximum PR interval \>=300 milliseconds (msec) and maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) \>=25 percent (%) for baseline value of \>200 msec and Pctchg\>=50% for baseline value of \<=200 msec for PR interval, maximum QRS interval \>=140 msec and a maximum IFB: Pctchg\>=50%, maximum QTCF interval (Fridericia's Correction) of 450 msec to \<480 msec, 480 msec to \<500 msec or \>=500 msec and a maximum change of \<=30change\<60 or \>=60 msec from baseline.

Secondary Endpoints
Area under the Concentration-Time Curve (AUC)
BaselineDay 1, Day , Day 15, Day 22 & Day 25, Day 29 post dose
Cmax
Baseline, Day 1, Day , Day 15, Day 22 & Day 25, Day 29 post dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORThe same composition as the active medication but without the active substance TA-46
TA-46EXPERIMENTALDecoy protein of the fibroblast growth factor receptor 3
Interventions
NameTypeDescription
TA-46BIOLOGICALDecoy protein of the fibroblast growth factor receptor 3, 50 mg/mL (Parts A, B and C) and 120 mg/mL (Part C and Part D), sc solution for injection/infusion
PlaceboOTHERThe same composition as the active medication but without the active substance TA-46
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Eligibility Criteria
Age Range21 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria:- * Age : 21-55 years, inclusive, at screening * Weight : maximum weight of 100 kg * Normal height without any growth complications during childhood * Healthy as determined by screening assessments Exclusion Criteria: * Concomitant disease or condition that could interfere with...

Countries:Netherlands
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