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 being developed by Pfizer, Inc. (NYSE: PFE). It is currently in Phase 1 clinical development and has been studied in healthy volunteers. The drug is administered via subcutaneous injection.
TA-46 is being studied for use in healthy volunteers as part of early clinical development. Its intended therapeutic use has not been established, as it is still in Phase 1 trials focused on safety, tolerability, and pharmacokinetics.
TA-46 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials to evaluate the drug's safety and pharmacokinetic profile.
TA-46 is in Phase 1 clinical development. One Phase 1 trial has been completed, which enrolled 78 healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.
TA-46 was studied in a Phase 1 clinical trial registered as NCT04410809, titled "Study Of Safety, Tolerability And Pharmacokinetics Of Subcutaneous Doses Of TA-46." The trial was completed and enrolled 78 healthy volunteers in the Netherlands.
TA-46 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial focused on safety, tolerability, and pharmacokinetics in healthy volunteers, and further clinical development would be required for potential approval.