Study Of Safety, Tolerability And Pharmacokinetics Of Subcutaneous Doses Of TA-46

NCT04410809 | Completed Phase 1

• 3 other identifiers: TA46-0012017-003596-55C4181002
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

TA-46 single- and multiple-ascending dose study in healthy volunteers to investigate safety and PK. The protocol is conducted in four parts; Part A - Single Ascending doses of TA46 Part B - Multiple Ascending doses of TA-46 Part C - Comparing 2 formulations 50mg/ml vs 120mg/ml TA-46 Part D - Single Ascending dose of TA46 120mg/ml formulation The subjects will be in the clinic for 1 period. The subjects will be admitted to the clinical research center in the afternoon of Day -1. They will be discharged on Day 4 (72 hours post-dose) after completion of the assessments. After discharge, the subjects will return to the clinical research center for ambulatory visits on Days 5, 8, 10, 12, 14 and 22

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

  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.

  Bsseline to Day 43 after last dose of study medication

• Number of Participants With Clinical Laboratory Abnormalities

  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 \[urine mucus and leucocytes\]).

  Baseline up to Day 43 after last dose of study medication

• Incidence of Anti-Drug Antibody (ADA)

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

  Baselin up to Day 43 after last dose of study medication

• Number of Participants With Change From Baseline in Physical Examinations and Vital Signs

  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).

  Baseline up to Day 43 after last dose study medication

• Number of Participants With Abnormal Electrocardiogram (ECG)

  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.

  Baseline up to Day 22 after last dose of study medication

Secondary Outcomes (2)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

The same composition as the active medication but without the active substance TA-46

Other: Placebo

TA-46

EXPERIMENTAL

Decoy protein of the fibroblast growth factor receptor 3

Biological: TA-46

Interventions

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

TA-46

Placebo OTHER

The same composition as the active medication but without the active substance TA-46

Placebo

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study, or that would, in the opinion of the PI, pose an unacceptable risk to the subject in this study
• Clinically significant abnormalities in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis)
• Participation in an investigational drug or device study within 3 months prior to (the first) drug administration in the current study

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

PRA

Groningen, 9728 NZ, Netherlands

Location

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 1, 2020
• Study Start: January 19, 2018
• Primary Completion: November 27, 2019
• Study Completion: November 27, 2019
• Last Updated: June 1, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)