Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this clinical trial is to learn about the safety of the study medicine (ponsegromab) and how it undergoes change and elimination in healthy Chinese adults. This study is seeking male and female Chinese participants who are very healthy as confirmed after some medical tests.
All participants in this study will receive Ponsegromab only once:
We will measure the amount of the study medicine in the blood of the participants after giving the shots. Later we will examine experiences of people receiving the study medicine. This will help us understand how the medicine is changed and eliminated from your body and to decide if the study medicine is safe. Participants will take part in this study for 22 weeks. During this time, they will stay at the study clinic for the first 8 days and will visit the study clinic about 8 times.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ponsegromab low dose | Experimental |
| |
| Ponsegromab high dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ponsegromab | Drug | Participants will receive one subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Serum Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Unbound and Total Ponsegromab | AUCinf was defined as area under the serum concentration-time profile from time 0 extrapolated to infinite time. | Pre-dose, 12, 24, 48, 72, 120, 168 hours after dose on Day 1, Days 10, 15, 29, 50, 71, 93, 106, and 127 |
| Area Under the Serum Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Unbound and Total Ponsegromab | AUClast was defined as area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. | Pre-dose, 12, 24, 48, 72, 120, 168 hours after dose on Day 1, Days 10, 15, 29, 50, 71, 93, 106, and 127 |
| Maximum Observed Serum Concentration (Cmax) of Unbound and Total Ponsegromab | Cmax was defined as maximum observed concentration. Cmax was observed directly from data. | Pre-dose, 12, 24, 48, 72, 120, 168 hours after dose on Day 1, Days 10, 15, 29, 50, 71, 93, 106, and 127 |
| Time for Cmax (Tmax) of Unbound and Total Ponsegromab | Tmax was defined as time for Cmax. Tmax was observed directly from data as time of first occurrence. | Pre-dose, 12, 24, 48, 72, 120, 168 hours after dose on Day 1, Days 10, 15, 29, 50, 71, 93, 106, and 127 |
| Terminal Half Life (t1/2) of Unbound and Total Ponsegromab | t1/2 was defined as terminal half life. t1/2 was calculated as Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. | Pre-dose, 12, 24, 48, 72, 120, 168 hours after dose on Day 1, Days 10, 15, 29, 50, 71, 93, 106, and 127 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 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. TEAEs were defined as events that started on or after the first dose but before the end of the study (approximately 18 weeks post dose on Day 1). An SAE was defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
History of HIV infection, syphilis, hepatitis B, or hepatitis C; positive testing for HIV, syphilis, HBsAg, or HCVAb. Hepatitis B vaccination is allowed.
History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody or molecules made of components of monoclonal antibodies.
History of recurrent infections or active infection within 28 days of screening.
History of sensitivity to heparin or heparin-induced thrombocytopenia.
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to COVID-19 pandemic (eg, contact with positive case, residence, or travel to an area with high incidence) that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
Exposure to live vaccines within 28 days of screening.
Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or marketed or investigational monoclonal antibodies within 3 months or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
A positive urine drug test.
Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
Screening 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline QTcF interval >450 msec, or QRS interval >120 msec). If the baseline uncorrected QT interval is >450 msec, this interval should be rate-corrected using the Fridericia method and the resulting QTcF should be used for decision making and reporting. If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTcF or QRS values should be used to determine the participant's eligibility. Computer-interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding a participant.
Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary:
COVID-19 positive.
History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 240 mL beer, 30 mL of 40% spirit or 90 mL of wine).
Blood donation (excluding plasma donations) of approximately 400 mL or more within 60 days prior to dosing.
Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Fudan University | Shanghai | Shanghai Municipality | 201107 | China | ||
| HuaShan Hospital |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
A total of 18 participants were screened and assigned to receive the study intervention. All of them received ponsegromab. All 18 participants completed treatment and follow-up phases.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Ponsegromab 100 mg | Participants in Cohort 1 (ponsegromab 100 mg cohort) received a single subcutaneous (SC) dose of ponsegromab 100 mg on Day 1. |
| FG001 | Cohort 2: Ponsegromab 400 mg | Participants in Cohort 2 (ponsegromab 400 mg cohort) received a single SC dose of ponsegromab 400 mg on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants who received at least 1 dose of study intervention.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Ponsegromab 100 mg | Participants in Cohort 1 (ponsegromab 100 mg cohort) received a single SC dose of ponsegromab 100 mg on Day 1. |
| BG001 | Cohort 2: Ponsegromab 400 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Serum Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Unbound and Total Ponsegromab | AUCinf was defined as area under the serum concentration-time profile from time 0 extrapolated to infinite time. | All enrolled participants who received a dose of ponsegromab and who had at least 1 of the serum pharmacokinetic (PK) parameters of interest calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram (ng)*day/milliliter (mL) | Pre-dose, 12, 24, 48, 72, 120, 168 hours after dose on Day 1, Days 10, 15, 29, 50, 71, 93, 106, and 127 |
|
From the first dose of study intervention on Day 1 to Day 127
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: Ponsegromab 100 mg | Participants in Cohort 1 (ponsegromab 100 mg cohort) received a single SC dose of ponsegromab 100 mg on Day 1. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block first degree | Cardiac disorders | MedDRA 26.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 22, 2022 | Jun 14, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 18, 2022 | Jun 14, 2024 | SAP_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ponsegromab |
| Drug |
Participants will receive four subcutaneous injections |
|
| From the first dose of study intervention on Day 1 to Day 127 |
| Number of Participants With Treatment-Related TEAEs and SAEs | 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. TEAEs were defined as events that started on or after the first dose but before the end of the study (approximately 18 weeks post dose on Day 1). An SAE was defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect. Causality of the TEAEs and SAEs was judged by the investigator. | From the first dose of study intervention on Day 1 to Day 127 |
| Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality | Hematology parameters included hemoglobin, hematocrit, red blood cell, white blood cell and platelet count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, mean platelet volume, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. Chemistry parameters included blood urea nitrogen, glucose (fasting), calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, and creatinine. Urine parameters included pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy. Only those categories in which at least 1 participant had data were reported. | From the first dose of study intervention on Day 1 to Day 127 |
| Number of Participants With Clinically Significant Change in Vital Signs | Vital sign measurements included supine blood pressure and pulse rate. Any safety assessments (vital sign measurements) including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the investigator or were considered meeting the AE definition and are listed below. | From the first dose of study intervention on Day 1 to Day 127 |
| Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) | ECG abnormalities criteria included: 1) maximum QTc interval adjusted according to Fridericia formula (QTcF) (msec): >450, >480, >500, increase from baseline >30, increase from baseline >30, >60; 2) maximum pulse rate (msec): ≥300, baseline >200 and maximum increase ≥25%, baseline ≤200 and maximum increase ≥50%; 3) maximum QRS (msec): ≥140, increase ≥50%. | From the first dose of study intervention on Day 1 to Day 127 |
| Shanghai |
| Shanghai Municipality |
| 201107 |
| China |
Participants in Cohort 2 (ponsegromab 400 mg cohort) received a single SC dose of ponsegromab 400 mg on Day 1.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Cohort 2: Ponsegromab 400 mg |
Participants in Cohort 2 (ponsegromab 400 mg cohort) received a single SC dose of ponsegromab 400 mg on Day 1. |
|
|
| Primary | Area Under the Serum Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Unbound and Total Ponsegromab | AUClast was defined as area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. | All enrolled participants who received a dose of ponsegromab and who had at least 1 of the serum PK parameters of interest calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*day/mL | Pre-dose, 12, 24, 48, 72, 120, 168 hours after dose on Day 1, Days 10, 15, 29, 50, 71, 93, 106, and 127 |
|
|
|
| Primary | Maximum Observed Serum Concentration (Cmax) of Unbound and Total Ponsegromab | Cmax was defined as maximum observed concentration. Cmax was observed directly from data. | All enrolled participants who received a dose of ponsegromab and who had at least 1 of the serum PK parameters of interest calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, 12, 24, 48, 72, 120, 168 hours after dose on Day 1, Days 10, 15, 29, 50, 71, 93, 106, and 127 |
|
|
|
| Primary | Time for Cmax (Tmax) of Unbound and Total Ponsegromab | Tmax was defined as time for Cmax. Tmax was observed directly from data as time of first occurrence. | All enrolled participants who received a dose of ponsegromab and who had at least 1 of the serum PK parameters of interest calculated. | Posted | Median | Full Range | day | Pre-dose, 12, 24, 48, 72, 120, 168 hours after dose on Day 1, Days 10, 15, 29, 50, 71, 93, 106, and 127 |
|
|
|
| Primary | Terminal Half Life (t1/2) of Unbound and Total Ponsegromab | t1/2 was defined as terminal half life. t1/2 was calculated as Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. | All enrolled participants who received a dose of ponsegromab and who had at least 1 of the serum PK parameters of interest calculated. | Posted | Mean | Standard Deviation | day | Pre-dose, 12, 24, 48, 72, 120, 168 hours after dose on Day 1, Days 10, 15, 29, 50, 71, 93, 106, and 127 |
|
|
|
| Secondary | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 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. TEAEs were defined as events that started on or after the first dose but before the end of the study (approximately 18 weeks post dose on Day 1). An SAE was defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect. | All enrolled participants who received a dose of ponsegromab. | Posted | Count of Participants | Participants | From the first dose of study intervention on Day 1 to Day 127 |
|
|
|
| Secondary | Number of Participants With Treatment-Related TEAEs and SAEs | 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. TEAEs were defined as events that started on or after the first dose but before the end of the study (approximately 18 weeks post dose on Day 1). An SAE was defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect. Causality of the TEAEs and SAEs was judged by the investigator. | All enrolled participants who received a dose of ponsegromab. | Posted | Count of Participants | Participants | From the first dose of study intervention on Day 1 to Day 127 |
|
|
|
| Secondary | Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality | Hematology parameters included hemoglobin, hematocrit, red blood cell, white blood cell and platelet count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, mean platelet volume, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. Chemistry parameters included blood urea nitrogen, glucose (fasting), calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, and creatinine. Urine parameters included pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy. Only those categories in which at least 1 participant had data were reported. | All enrolled participants who received a dose of ponsegromab. | Posted | Count of Participants | Participants | From the first dose of study intervention on Day 1 to Day 127 |
|
|
|
| Secondary | Number of Participants With Clinically Significant Change in Vital Signs | Vital sign measurements included supine blood pressure and pulse rate. Any safety assessments (vital sign measurements) including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the investigator or were considered meeting the AE definition and are listed below. | All enrolled participants who received a dose of ponsegromab. | Posted | Count of Participants | Participants | From the first dose of study intervention on Day 1 to Day 127 |
|
|
|
| Secondary | Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) | ECG abnormalities criteria included: 1) maximum QTc interval adjusted according to Fridericia formula (QTcF) (msec): >450, >480, >500, increase from baseline >30, increase from baseline >30, >60; 2) maximum pulse rate (msec): ≥300, baseline >200 and maximum increase ≥25%, baseline ≤200 and maximum increase ≥50%; 3) maximum QRS (msec): ≥140, increase ≥50%. | All enrolled participants who received a dose of ponsegromab. | Posted | Count of Participants | Participants | From the first dose of study intervention on Day 1 to Day 127 |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 4 |
| 9 |
| EG001 | Cohort 2: Ponsegromab 400 mg | Participants in Cohort 2 (ponsegromab 400 mg cohort) received a single SC dose of ponsegromab 400 mg on Day 1. | 0 | 9 | 0 | 9 | 7 | 9 |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
|
| Urine ketone body present | Investigations | MedDRA 26.0 | Non-systematic Assessment |
|
| Urine leukocyte esterase positive | Investigations | MedDRA 26.0 | Non-systematic Assessment |
|
| Urobilinogen urine increased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
|
| White blood cells urine positive | Investigations | MedDRA 26.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Mechanical urticaria | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
|
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.
| Total ponsegromab |
|
|
| Lymphocytes (10^3/mm^3) >1.2 x ULN |
|
| Neutrophils (10^9/L) <0.8 x LLN |
|
| Alanine Aminotransferase (U/L) >3.0 x ULN |
|
| Urate (mg/dL) >1.2 x ULN |
|
| pH (Scalar) <1.0 x LLN |
|
| Ketones ≥1 |
|
| Urine Hemoglobin ≥1 |
|
| Urobilinogen ≥1 |
|
| Leukocyte Esterase ≥1 |
|
| Urine Leukocytes (/uL) >1.0 x ULN |
|
| Epithelial Cells ≥6 |
|