Trial Outcomes & Findings for Evaluation of the Pharmacokinetics, Safety and Tolerability of Single Dose of PF-06480605 in Chinese Healthy Participants (NCT NCT05107492)
NCT ID: NCT05107492
Last Updated: 2024-03-21
Results Overview
Cmax is the maximum observed plasma concentration.
COMPLETED
PHASE1
12 participants
At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1
2024-03-21
Participant Flow
A total of 12 Chinese healthy adult participants were enrolled, with 9 assigned to PF-06480605 450mg group and 3 to placebo.
This was a placebo-controlled study of PF-06480605 following 450 mg and 150 mg (if needed) in Chinese healthy adults. Optional 150 mg cohort was not conducted as pharmacokinetic (PK) data of 450mg group did not suggest ethnic difference with previous Western/Japanese studies (by comparing dose-normalized mean exposures/dose-normalized mean concentrations profiles).
Participant milestones
| Measure |
PF-06480605 450mg
Participants received a single subcutaneous dose of PF-06480605 450 mg on Day 1.
|
Placebo
Participants received matching placebo on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
3
|
|
Overall Study
COMPLETED
|
8
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
PF-06480605 450mg
Participants received a single subcutaneous dose of PF-06480605 450 mg on Day 1.
|
Placebo
Participants received matching placebo on Day 1.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Evaluation of the Pharmacokinetics, Safety and Tolerability of Single Dose of PF-06480605 in Chinese Healthy Participants
Baseline characteristics by cohort
| Measure |
PF-06480605 450mg
n=9 Participants
Participants received a single subcutaneous dose of PF-06480605 450 mg on Day 1.
|
Placebo
n=3 Participants
Participants received matching placebo on Day 1.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34 Years
n=5 Participants
|
28 Years
n=7 Participants
|
34 Years
n=5 Participants
|
|
Age, Customized
<18
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
18-44
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Customized
45-64
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
>=65
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian (Chinese)
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1Population: The PK parameter analysis population was defined as all randomized participants who received at least 1 dose of study intervention and for whom at least 1 of the PK parameters of interest was calculated. Data for this outcome measure (OM) was not planned to be collected and analyzed for placebo arm.
Cmax is the maximum observed plasma concentration.
Outcome measures
| Measure |
PF-06480605 450mg
n=9 Participants
Participants who received PF-06480605 450mg
|
Placebo
Participants who received placebo
|
|---|---|---|
|
Maximum Observed Concentration (Cmax) of PF-06480605
|
41530 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 26
|
—
|
PRIMARY outcome
Timeframe: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1Population: The PK parameter analysis population was defined as all randomized participants who received at least 1 dose of study intervention and for whom at least 1 of the PK parameters of interest was calculated. Data for this OM was not planned to be collected and analyzed for placebo arm.
Tmax is the time for Cmax.
Outcome measures
| Measure |
PF-06480605 450mg
n=9 Participants
Participants who received PF-06480605 450mg
|
Placebo
Participants who received placebo
|
|---|---|---|
|
Time for Cmax (Tmax) of PF-06480605
|
96.00 hour
Interval 95.9 to 335.0
|
—
|
PRIMARY outcome
Timeframe: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, and 336 hours post dose on Day 1Population: The PK parameter analysis population was defined as all randomized participants who received at least 1 dose of study intervention and for whom at least 1 of the PK parameters of interest was calculated. Data for this OM was not planned to be collected and analyzed for placebo arm.
AUC14day is area under the curve from time 0 to end of dosing interval (Day 14, 336 hours).
Outcome measures
| Measure |
PF-06480605 450mg
n=9 Participants
Participants who received PF-06480605 450mg
|
Placebo
Participants who received placebo
|
|---|---|---|
|
Area Under the Curve From Time 0 to End of Dosing Interval (AUC14day) of PF-06480605
|
11600000 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 26
|
—
|
PRIMARY outcome
Timeframe: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1Population: The PK parameter analysis population was defined as all randomized participants who received at least 1 dose of study intervention and for whom at least 1 of the PK parameters of interest was calculated. Data for this OM was not planned to be collected and analyzed for placebo arm.
AUCinf is area under the plasma concentration time profile from time 0 extrapolated to infinite time.
Outcome measures
| Measure |
PF-06480605 450mg
n=9 Participants
Participants who received PF-06480605 450mg
|
Placebo
Participants who received placebo
|
|---|---|---|
|
Area Under the Plasma Concentration Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06480605
|
31390000 ng*hr/mL
Geometric Coefficient of Variation 32
|
—
|
PRIMARY outcome
Timeframe: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1Population: The PK parameter analysis population was defined as all randomized participants who received at least 1 dose of study intervention and for whom at least 1 of the PK parameters of interest was calculated. Data for this OM was not planned to be collected and analyzed for placebo arm.
t1/2 is the terminal half-life (time required for the plasma concentration to decline by 50%)
Outcome measures
| Measure |
PF-06480605 450mg
n=9 Participants
Participants who received PF-06480605 450mg
|
Placebo
Participants who received placebo
|
|---|---|---|
|
Terminal Half-life (t1/2) of PF-06480605
|
306.4 hour
Standard Deviation 134.49
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 114Population: The safety analysis set included all randomized participants who received at least 1 dose of study intervention.
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE (SAE) was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; or other serious situations such as important medical events. TEAEs were events between first dose of study drug and before the end of study (up to follow-up visits). AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.
Outcome measures
| Measure |
PF-06480605 450mg
n=9 Participants
Participants who received PF-06480605 450mg
|
Placebo
n=3 Participants
Participants who received placebo
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
All-causality TEAEs
|
7 Participants
|
3 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Treatment-related TEAEs
|
7 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From Baseline (BL) to Day 114Population: The safety analysis set included all randomized participants who received at least 1 dose of study intervention. Participants with evaluable vital signs data were analyzed.
Vital signs abnormalities included: supine diastolic blood pressure (BP) increase and decrease from BL of \>=20mmHg or absolute value \<50mmHg; systolic BP increase and decrease from BL of \>=30mmHg or absolute value \<90mmHg; pulse rate \<40 or \>120bpm.
Outcome measures
| Measure |
PF-06480605 450mg
n=9 Participants
Participants who received PF-06480605 450mg
|
Placebo
n=3 Participants
Participants who received placebo
|
|---|---|---|
|
Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From BL to Day 114Population: The safety analysis set included all randomized participants who received at least 1 dose of study intervention.
ECG assessments included PR, QT, and QTc intervals and QRS complex. ECG abnormalities included PR interval BL \>200msec and max \>=25% increase from BL, or BL \<=200msec and max \>=50% increase from BL, or absolute value \>=300msec; QRS interval percent change from BL \>=50% or absolute value \>=140msec, QTcF change from BL \>=30msec, or absolute value \>450msec.
Outcome measures
| Measure |
PF-06480605 450mg
n=9 Participants
Participants who received PF-06480605 450mg
|
Placebo
n=3 Participants
Participants who received placebo
|
|---|---|---|
|
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From BL to Day 114Population: The safety analysis set included all randomized participants who received at least 1 dose of study intervention.
Safety laboratory assessments included clinical chemistry, hematology, urinalysis, and other tests. Abnormality was determined at the investigator's discretion. Laboratory test abnormalities reported by at least 1 participant are reported in this outcome measure.
Outcome measures
| Measure |
PF-06480605 450mg
n=9 Participants
Participants who received PF-06480605 450mg
|
Placebo
n=3 Participants
Participants who received placebo
|
|---|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Neutrophils > 1.2 x Upper Limit of Normal (ULN)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Basophils > 1.2 x ULN
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Monocytes > 1.2 x ULN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Alanine Aminotransferase > 3.0 x ULN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Ketones >=1
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1Population: The PK parameter analysis population was defined as all randomized participants who received at least 1 dose of study intervention and for whom at least 1 of the PK parameters of interest was calculated. Data for this OM was not planned to be collected and analyzed for placebo arm.
AUClast is area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration
Outcome measures
| Measure |
PF-06480605 450mg
n=9 Participants
Participants who received PF-06480605 450mg
|
Placebo
Participants who received placebo
|
|---|---|---|
|
Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06480605
|
29990000 ng*hr/mL
Geometric Coefficient of Variation 28
|
—
|
SECONDARY outcome
Timeframe: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1Population: The PK parameter analysis population was defined as all randomized participants who received at least 1 dose of study intervention and for whom at least 1 of the PK parameters of interest was calculated. Data for this OM was not planned to be collected and analyzed for placebo arm.
Vz/F is the apparent volume of distribution, defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Outcome measures
| Measure |
PF-06480605 450mg
n=9 Participants
Participants who received PF-06480605 450mg
|
Placebo
Participants who received placebo
|
|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of PF-06480605
|
5.839 liter (L)
Geometric Coefficient of Variation 42
|
—
|
SECONDARY outcome
Timeframe: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1Population: The PK parameter analysis population was defined as all randomized participants who received at least 1 dose of study intervention and for whom at least 1 of the PK parameters of interest was calculated. Data for this OM was not planned to be collected and analyzed for placebo arm.
CL/F is the apparent oral clearance, which is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Outcome measures
| Measure |
PF-06480605 450mg
n=9 Participants
Participants who received PF-06480605 450mg
|
Placebo
Participants who received placebo
|
|---|---|---|
|
Apparent Oral Clearance (CL/F) of PF-06480605
|
0.01434 liter per hour (L/hr)
Geometric Coefficient of Variation 32
|
—
|
SECONDARY outcome
Timeframe: On Days 1 (prior to dose), 15, 29, 57, 85 and 114Population: The immunogenicity analysis set included all randomized participants who received at least 1 dose of study intervention with at least 1 post-treatment anti-drug (PF-06480605) antibody determination. Number analyzed = Number of participants with observed ADA results at the specific visit.
Summary of ADA incidence by visit is presented. ADA positive was defined as titer \>=60.
Outcome measures
| Measure |
PF-06480605 450mg
n=9 Participants
Participants who received PF-06480605 450mg
|
Placebo
Participants who received placebo
|
|---|---|---|
|
Number of Participants With Positivie Anti-drug Antibody (ADA) Against PF-06480605
Day 1 (Baseline)
|
0 Participants
|
—
|
|
Number of Participants With Positivie Anti-drug Antibody (ADA) Against PF-06480605
Day 15
|
1 Participants
|
—
|
|
Number of Participants With Positivie Anti-drug Antibody (ADA) Against PF-06480605
Day 29
|
4 Participants
|
—
|
|
Number of Participants With Positivie Anti-drug Antibody (ADA) Against PF-06480605
Day 57
|
8 Participants
|
—
|
|
Number of Participants With Positivie Anti-drug Antibody (ADA) Against PF-06480605
Day 85
|
6 Participants
|
—
|
|
Number of Participants With Positivie Anti-drug Antibody (ADA) Against PF-06480605
Day 114
|
7 Participants
|
—
|
SECONDARY outcome
Timeframe: On Days 1 (prior to dose), 15, 29, 57, 85 and 114Population: The immunogenicity analysis set included all randomized participants who received at least 1 dose of study intervention with at least 1 post-treatment anti-drug (PF-06480605) antibody determination. Number of Participants Analyzed = the total number of participants who had ADA-positive results in this study. Number Analyzed = Number of participants who had ADA-positive results at the specific visit.
Summary of NAb incidence by visit is presented. NAb positive was defined as titer \>=5. ADA-positive participants (defined as titer \>=60) were analyzed for NAb.
Outcome measures
| Measure |
PF-06480605 450mg
n=9 Participants
Participants who received PF-06480605 450mg
|
Placebo
Participants who received placebo
|
|---|---|---|
|
Number of Participants With Neutralizing Antibody (NAb) Against PF-06480605
Day 1 (Baseline)
|
0 Participants
|
—
|
|
Number of Participants With Neutralizing Antibody (NAb) Against PF-06480605
Day 15
|
0 Participants
|
—
|
|
Number of Participants With Neutralizing Antibody (NAb) Against PF-06480605
Day 29
|
0 Participants
|
—
|
|
Number of Participants With Neutralizing Antibody (NAb) Against PF-06480605
Day 57
|
1 Participants
|
—
|
|
Number of Participants With Neutralizing Antibody (NAb) Against PF-06480605
Day 85
|
0 Participants
|
—
|
|
Number of Participants With Neutralizing Antibody (NAb) Against PF-06480605
Day 114
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: On Days 1 (prior to dose), 2, 5, 15, 29, 57, 85 and 114Population: The pharmacodynamic (PD) analysis set included all randomized participants who had at least 1 PD assessment.
The total sTL1A protein concentration in serum is summarized by time.
Outcome measures
| Measure |
PF-06480605 450mg
n=9 Participants
Participants who received PF-06480605 450mg
|
Placebo
n=3 Participants
Participants who received placebo
|
|---|---|---|
|
Total Soluble Tumor Necrosis Factor Like Ligand 1A (sTL1A) Protein Concentration in Serum
Day 1 (Baseline)
|
99.7 picogram per milliliter (pg/mL)
Standard Deviation 15.73
|
89.7 picogram per milliliter (pg/mL)
Standard Deviation 17.71
|
|
Total Soluble Tumor Necrosis Factor Like Ligand 1A (sTL1A) Protein Concentration in Serum
Day 2
|
314.1 picogram per milliliter (pg/mL)
Standard Deviation 75.62
|
110.1 picogram per milliliter (pg/mL)
Standard Deviation 23.46
|
|
Total Soluble Tumor Necrosis Factor Like Ligand 1A (sTL1A) Protein Concentration in Serum
Day 5
|
1470.3 picogram per milliliter (pg/mL)
Standard Deviation 409.89
|
97.2 picogram per milliliter (pg/mL)
Standard Deviation 14.39
|
|
Total Soluble Tumor Necrosis Factor Like Ligand 1A (sTL1A) Protein Concentration in Serum
Day 15
|
3817.8 picogram per milliliter (pg/mL)
Standard Deviation 1172.54
|
116.0 picogram per milliliter (pg/mL)
Standard Deviation 25.98
|
|
Total Soluble Tumor Necrosis Factor Like Ligand 1A (sTL1A) Protein Concentration in Serum
Day 29
|
3319.2 picogram per milliliter (pg/mL)
Standard Deviation 2096.47
|
109.6 picogram per milliliter (pg/mL)
Standard Deviation 13.72
|
|
Total Soluble Tumor Necrosis Factor Like Ligand 1A (sTL1A) Protein Concentration in Serum
Day 57
|
2126.0 picogram per milliliter (pg/mL)
Standard Deviation 2473.33
|
123.0 picogram per milliliter (pg/mL)
Standard Deviation 22.61
|
|
Total Soluble Tumor Necrosis Factor Like Ligand 1A (sTL1A) Protein Concentration in Serum
Day 85
|
571.7 picogram per milliliter (pg/mL)
Standard Deviation 548.71
|
110.9 picogram per milliliter (pg/mL)
Standard Deviation 22.86
|
|
Total Soluble Tumor Necrosis Factor Like Ligand 1A (sTL1A) Protein Concentration in Serum
Day 114
|
597.6 picogram per milliliter (pg/mL)
Standard Deviation 404.22
|
108.7 picogram per milliliter (pg/mL)
Standard Deviation 8.02
|
Adverse Events
PF-06480605 450mg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PF-06480605 450mg
n=9 participants at risk
Participants received a single subcutaneous dose of PF-06480605 450 mg on Day 1.
|
Placebo
n=3 participants at risk
Participants received matching placebo on Day 1.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
3/9 • Day 1 to Day 114
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
33.3%
1/3 • Day 1 to Day 114
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9 • Day 1 to Day 114
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/3 • Day 1 to Day 114
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
|
Gastrointestinal disorders
Mouth ulceration
|
11.1%
1/9 • Day 1 to Day 114
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/3 • Day 1 to Day 114
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
|
Gastrointestinal disorders
Tongue ulceration
|
11.1%
1/9 • Day 1 to Day 114
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/3 • Day 1 to Day 114
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
|
General disorders
Injection site reaction
|
55.6%
5/9 • Day 1 to Day 114
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
33.3%
1/3 • Day 1 to Day 114
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
3/9 • Day 1 to Day 114
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/3 • Day 1 to Day 114
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
1/9 • Day 1 to Day 114
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/3 • Day 1 to Day 114
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
1/9 • Day 1 to Day 114
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/3 • Day 1 to Day 114
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
|
Investigations
Blood glucose increased
|
11.1%
1/9 • Day 1 to Day 114
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
33.3%
1/3 • Day 1 to Day 114
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/9 • Day 1 to Day 114
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
33.3%
1/3 • Day 1 to Day 114
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
11.1%
1/9 • Day 1 to Day 114
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/3 • Day 1 to Day 114
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
1/9 • Day 1 to Day 114
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/3 • Day 1 to Day 114
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
11.1%
1/9 • Day 1 to Day 114
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
0.00%
0/3 • Day 1 to Day 114
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER