HealthyPhase 1NCT04410809
Study Of Safety, Tolerability And Pharmacokinetics Of Subcutaneous Doses Of TA-46
A Phase 1 study testing TA-46 in people with Healthy, run by Pfizer at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TA-46
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Jan 2018to 27 Nov 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A SINGLE-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY INVESTIGATING THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF SINGLE- AND MULTIPLE-ASCENDING SUBCUTANEOUS DOSES OF TA-46 IN HEALTHY VOLUNTEERS
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
Read the detailed description
This is a single-center, 34-part clinical study in healthy subjects.
Part A This is a single-center, double-blind, randomized, placebo-controlled, single ascending dose study in healthy subjects. The dose escalation is adaptive in nature. An estimated number of 5 dose levels will be administered in Part A of the study, with at each dose level 6 subjects randomized to receive TA-46 and 2 to receive placebo. Depending on evaluation of the data the number of subjects may be adjusted and/or additional group(s) may be added.
In this first-in-human study, the subjects participating at all dose levels of Part A (Groups A1-A5), will be dosed according to a sentinel dosing design to ensure optimal safety. This means that initially 2 subjects will be dosed: 1 subject with TA-46 and 1 subject with placebo. If the safety and tolerability results of the first 24 hours following dosing for the initial subjects are acceptable to the Principal Investigator (PI), the other 6 subjects (5 active and 1 placebo) of that dose level may be dosed.
For Groups A1 and A2, TA-46 and placebo will be administered as a sc injection (bolus) and for Groups A3-A5, TA-46 and placebo will be administered as a sc infusion. When TA-46 and placebo will be administered as sc infusion, the duration of the sc infusion will be dependent on the volume to be administered, but will not exceed a period of 1 hour. The dose levels of TA-46 can be increased or decreased based on the results of the previous group(s).
Part B This is a single-center, double-blind, randomized, placebo-controlled, multiple ascending dose study in healthy subjects. The dose escalation is adaptive in nature. TA-46 will be administered twice weekly for4 weeks. An estimated number of 3 dose levels will be administered in Part B of the study, with at each dose level 6 subjects randomized to receive TA-46 and 2 to receive placebo. Depending on evaluation of the data the number of subjects may be adjusted and/or additional group(s) may be added. Based on the results of Groups B1 and B2 of Part B, which followed a twice weekly dosing scheme for 4 weeks, the dosing scheme of Group B3 will be adapted to once weekly administration for 4 weeks and 31 additional groups (Groups B4 to B6) with the same dosing frequency will be added to Part B of the study. Depending on evaluation of the data, additional group(s) may be added or planned group(s) may be skipped.
For Group B1, TA-46 and placebo will be administered as a sc injection (bolus) and for Groups B2 to B64, TA-46 and placebo will be administered as a sc infusion. When TA-46 and placebo will be administered as a sc infusion, the duration of the sc infusion will be dependent on the volume to be administered, but will not exceed a period of 1 hour. The dose levels of TA-46 can be increased or decreased based on the results of the previous group(s).
Administration of a dose level in Part B can be started after completion and review of the corresponding or higher dose level in Part A of the study.
Part C This is a single-center, single-dose, open-label, cross-over study in healthy subjects comparing 2 formulations of TA-46 (50 mg/mL and 120 mg/mL). A total of 6 subjects will receive Treatment A (TA-46 formulation 1) and Treatment B (TA-46 formulation 2) randomly assigned over 2 periods with 2 treatment sequences (Treatment A/B and Treatment B/A) with 3 subjects per treatment in each sequence.
The following treatments are planned to be administered according to the randomization code:
Group C1 Treatment A: sc administration of 3 mg/kg TA-46 formulation 1 Treatment B: sc administration of 3 mg/kg TA-46 formulation 2TA-46 formulation 1 will be administered as a a sc infusion. The duration of the sc infusion will be dependent on the volume to be administered, but will not exceed a period of 1 hour. TA-46 formulation 2 will be administered as 1-2 sc injection(s) (bolus).
The subjects will be in the clinic for 2 periods. Each period the subjects will be admitted to the clinical research center in the afternoon of Day -1 and 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 6, 9, 12, 16, and 22 of each period.
Part D This is a single-center, open-label, single-dose study in healthy subjects with the TA-46 formulation of 120 mg/mL.
TA-46 and placebo will be administered as a sc infusion. The duration of the sc infusion will be dependent on the volume to be administered, but will not exceed a period of 1 hour. Depending on evaluation of the data, additional group(s) may be added or planned group(s) may be skipped.
- Conditions
- Healthy
- Being tested
- TA-46, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TA-46Biological
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
PlaceboOther
The same composition as the active medication but without the active substance TA-46
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The same composition as the active medication but without the active substance TA-46 Receives: Other: Placebo |
| TA-46 | Experimental | Decoy protein of the fibroblast growth factor receptor 3 Receives: Biological: TA-46 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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]).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline up to Day 22 after last dose of study medication
Secondary outcomes (2)
Area under the Concentration-Time Curve (AUC)
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Measured: BaselineDay 1, Day , Day 15, Day 22 & Day 25, Day 29 post dose
Cmax
To compare the safety, tolerability and PK of single sc doses of 2 formulations of TA-46 (50 mg/mL and 120 mg/mL)
Measured: Baseline, Day 1, Day , Day 15, Day 22 & Day 25, Day 29 post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start19 Jan 2018
- Primary completion27 Nov 2019
- Study completion27 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410809
- Sponsor's protocol ID
- TA46-001
- Other IDs
- 2017-003596-55, C4181002, 2017
- Status last verified
- May 2020
- First submitted
- 28 May 2020
- Last updated
- 1 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A SINGLE-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY INVESTIGATING THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF SINGLE- AND MULTIPLE-ASCENDING SUBCUTANEOUS DOSES OF TA-46 IN HEALTHY VOLUNTEERS
- ClinicalTrials.gov ID
- NCT04410809
- Acronym / sponsor ID
- TA46-001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2018 (actual)
- Primary completion
- 27 Nov 2019 (actual)
- Study completion
- 27 Nov 2019 (actual)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is a single-center, 34-part clinical study in healthy subjects.
Part A This is a single-center, double-blind, randomized, placebo-controlled, single ascending dose study in healthy subjects. The dose escalation is adaptive in nature. An estimated number of 5 dose levels will be administered in Part A of the study, with at each dose level 6 subjects randomized to receive TA-46 and 2 to receive placebo. Depending on evaluation of the data the number of subjects may be adjusted and/or additional group(s) may be added.
In this first-in-human study, the subjects participating at all dose levels of Part A (Groups A1-A5), will be dosed according to a sentinel dosing design to ensure optimal safety. This means that initially 2 subjects will be dosed: 1 subject with TA-46 and 1 subject with placebo. If the safety and tolerability results of the first 24 hours following dosing for the initial subjects are acceptable to the Principal Investigator (PI), the other 6 subjects (5 active and 1 placebo) of that dose level may be dosed.
For Groups A1 and A2, TA-46 and placebo will be administered as a sc injection (bolus) and for Groups A3-A5, TA-46 and placebo will be administered as a sc infusion. When TA-46 and placebo will be administered as sc infusion, the duration of the sc infusion will be dependent on the volume to be administered, but will not exceed a period of 1 hour. The dose levels of TA-46 can be increased or decreased based on the results of the previous group(s).
Part B This is a single-center, double-blind, randomized, placebo-controlled, multiple ascending dose study in healthy subjects. The dose escalation is adaptive in nature. TA-46 will be administered twice weekly for4 weeks. An estimated number of 3 dose levels will be administered in Part B of the study, with at each dose level 6 subjects randomized to receive TA-46 and 2 to receive placebo. Depending on evaluation of the data the number of subjects may be adjusted and/or additional group(s) may be added. Based on the results of Groups B1 and B2 of Part B, which followed a twice weekly dosing scheme for 4 weeks, the dosing scheme of Group B3 will be adapted to once weekly administration for 4 weeks and 31 additional groups (Groups B4 to B6) with the same dosing frequency will be added to Part B of the study. Depending on evaluation of the data, additional group(s) may be added or planned group(s) may be skipped.
For Group B1, TA-46 and placebo will be administered as a sc injection (bolus) and for Groups B2 to B64, TA-46 and placebo will be administered as a sc infusion. When TA-46 and placebo will be administered as a sc infusion, the duration of the sc infusion will be dependent on the volume to be administered, but will not exceed a period of 1 hour. The dose levels of TA-46 can be increased or decreased based on the results of the previous group(s).
Administration of a dose level in Part B can be started after completion and review of the corresponding or higher dose level in Part A of the study.
Part C This is a single-center, single-dose, open-label, cross-over study in healthy subjects comparing 2 formulations of TA-46 (50 mg/mL and 120 mg/mL). A total of 6 subjects will receive Treatment A (TA-46 formulation 1) and Treatment B (TA-46 formulation 2) randomly assigned over 2 periods with 2 treatment sequences (Treatment A/B and Treatment B/A) with 3 subjects per treatment in each sequence.
The following treatments are planned to be administered according to the randomization code:
Group C1 Treatment A: sc administration of 3 mg/kg TA-46 formulation 1 Treatment B: sc administration of 3 mg/kg TA-46 formulation 2TA-46 formulation 1 will be administered as a a sc infusion. The duration of the sc infusion will be dependent on the volume to be administered, but will not exceed a period of 1 hour. TA-46 formulation 2 will be administered as 1-2 sc injection(s) (bolus).
The subjects will be in the clinic for 2 periods. Each period the subjects will be admitted to the clinical research center in the afternoon of Day -1 and 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 6, 9, 12, 16, and 22 of each period.
Part D This is a single-center, open-label, single-dose study in healthy subjects with the TA-46 formulation of 120 mg/mL.
TA-46 and placebo will be administered as a sc infusion. The duration of the sc infusion will be dependent on the volume to be administered, but will not exceed a period of 1 hour. Depending on evaluation of the data, additional group(s) may be added or planned group(s) may be skipped.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboThe same composition as the active medication but without the active substance TA-46 |
| TA-46 | Experimental | Biological: TA-46Decoy protein of the fibroblast growth factor receptor 3 |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TA-46Decoy 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 | Biological | TA-46 |
| PlaceboThe same composition as the active medication but without the active substance TA-46 | Other | Placebo |
Primary outcome
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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.
2 secondary outcomes
Area under the Concentration-Time Curve (AUC)
Time frame: BaselineDay 1, Day , Day 15, Day 22 & Day 25, Day 29 post dose
Cmax
Time frame: Baseline, Day 1, Day , Day 15, Day 22 & Day 25, Day 29 post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TA-46 in people with Healthy, run by Pfizer at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) (time frame: Bsseline to Day 43 after last dose of study medication). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2020.