Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TA-46 · 1 trial · 1 indication
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.
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 \[urine mucus and leucocytes\]).
The percentage of participants with positive ADA and neutralizing antibodies will be summarized for each treatment arm.
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).
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.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | The same composition as the active medication but without the active substance TA-46 |
| TA-46 | EXPERIMENTAL | Decoy protein of the fibroblast growth factor receptor 3 |
| Name | Type | Description |
|---|---|---|
| TA-46 | BIOLOGICAL | Decoy 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 |
| Placebo | OTHER | The same composition as the active medication but without the active substance TA-46 |
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...
TA-46 is an investigational monoclonal antibody developed by Pfizer, Inc. (NYSE: PFE). It has been studied in a Phase 1 clinical trial in healthy adult volunteers. TA-46 is not approved for any indication and remains in early clinical development.
TA-46 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 1 study of TA-46 conducted in the Netherlands.
TA-46 is in Phase 1 development. Its only recorded clinical trial, NCT04410809, was a Phase 1 study that has been completed. TA-46 is investigational and has not been approved by the FDA for any use.
TA-46 has been evaluated in one clinical trial, NCT04410809, titled Study Of Safety, Tolerability And Pharmacokinetics Of Subcutaneous Doses Of TA-46. The Phase 1 trial enrolled 78 healthy volunteers in the Netherlands, was randomized, double blind, and placebo controlled, and is now completed.
The Phase 1 trial of TA-46, NCT04410809, was a randomized, double blind, placebo controlled study of subcutaneous doses. It enrolled 78 healthy volunteers aged 21 years and older in the Netherlands and assessed safety, tolerability, and pharmacokinetics. The study has been completed.