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PF-07321332 Dose 1

Phase 1

Healthy Participants | Small molecule | Other |Pfizer, Inc.|Last Updated: Oct 15, 2024

Target and mechanism

Molecular targetIL-4, IL-13, TSLP
Target classCytokines
ModalitySmall molecule

Also known as sigvotatug vedotin, Sigvotatug Vedotin, PF-07275315 dose 1, PF-07275315

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment70

FDA Designations

No designations recorded

Clinical trial landscape

PF-07321332 Dose 1 · 1 trial · 1 indication

Phase 1 1
NCT04756531STUDY OF PF-07321332 IN HEALTHY PARTICIPANTSHealthy Participants
COMPLETED70 Analytics
PHASE1COMPLETED
STUDY OF PF-07321332 IN HEALTHY PARTICIPANTS
Healthy ParticipantsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Treatment Emergent Adverse Events (TEAEs) in PART-1: SAD
Post the single dose of study intervention till up to 36 days

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. TEAEs were those with initial onset or increasing in severity between the first dose of study intervention and up to 36 days after last dose of study intervention. A 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. SAEs were adjudicated according to the investigator's assessment. Treatment-related AEs and SAEs were determined by the investigator.

Number of Participants With Clinically Significant Change From Baseline in Vital Signs in PART-1: SAD
Baseline up to Day 2 of the final period

Vital signs (temperature, respiratory rate, pulse rate \[PR\], systolic blood pressure \[SBP\], and diastolic blood pressure \[DBP\]) were obtained with participants following at least 5 minutes of supine rest. Categorical criteria were defined as DBP: value \<50 millimeters of mercury (mm Hg), increase \>=20 mm Hg, or decrease \>=20 mm Hg; PR: value \<40 beats per minute (bpm) or value \>120 bpm; SBP: value \<90 mm Hg, increase \>=30 mm Hg, or decrease \>=30 mm Hg. Clinical significance of vital signs was determined at the investigator's discretion. The analysis population included all participants who received at least 1 dose of study intervention and had at least 1 assessment undertaken post treatment.

Number of Participants With Laboratory Abnormalities in PART-1: SAD
Baseline up to Day 4 of the final period

Laboratory parameters included hematology, chemistry, urinalysis, and other (urine drug screening, Severe Acute Respiratory Syndrome Coronavirus 2 \[SARS-CoV-2\] reverse transcription polymerase chain reaction \[RT-PCR\], estimated glomerular filtration rate \[eGFR\], pregnancy test \[beta human chorionic gonadotropin \[b-hCG\]\], activated partial thromboplastin time \[aPTT\], prothrombin time \[PT\] - international normalized ratio \[INR\], fibrinogen, thyroid stimulating hormone \[TSH\], Free thyroxine \[T4\]). The clinical significance of laboratory parameters was determined at the investigator's discretion. The analysis population included all participants who received at least 1 dose of the study intervention.

Number of Participants With TEAEs in PART-2:MAD
Post first dose till up to 45 days after last dose of study intervention

An 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 those with initial onset or increasing in severity between the first dose of study intervention and up to 36 days after last dose of study intervention. An 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. SAEs were adjudicated according to the investigator's assessment. Treatment-related AEs and SAEs were determined by the investigator.

Number of Participants With Clinically Significant Change From Baseline in Vital Signs in PART-2: MAD
Baseline up to Day 12

Vital signs (temperature, respiratory rate, PR, SBP, DBP) were obtained with participants following at least 5 minutes of supine rest. Categorical criteria were defined as DBP: value \<50 mm Hg, increase \>=20 mm Hg, or decrease \>=20 mm Hg; PR: value \<40 bpm or value \>120 bpm; SBP: value \<90 mm Hg, increase \>=30 mm Hg, or decrease \>=30 mm Hg. Clinical significance of vital signs was determined at the investigator's discretion.

Number of Participants With Laboratory Abnormalities in PART-2: MAD
Baseline up to Day 12

Laboratory parameters included hematology, chemistry, urinalysis, and other (urine drug screening, SARS-CoV-2 RT-PCR, eGFR, pregnancy test \[b-hCG\], aPTT, PT-INR, fibrinogen, TSH, Free T4). The clinical significance of laboratory parameters was determined at the investigator's discretion. The analysis population included all participants who received at least 1 dose of the study intervention.

Area Under the Plasma Concentration-Time Profile From Time 0 to The Time of The Last Quantifiable Concentration (AUClast) of Tablet Formulation and Suspension in PART-3: rBA/FE
Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, and 48 hours post-dose

AUClast is area under the concentration-time profile from time 0 (pre-dose) to the time of the last quantifiable concentration.

Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Tablet Formulation and Suspension in PART-3: rBA/FE
Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, and 48 hours post-dose

AUCinf is area under the concentration-time profile from time 0 (pre-dose) extrapolated to infinite time. Natural log transformed AUCinf for PF-07321332 was analyzed to provide an estimate of the ratio of adjusted geometric means (Test \[tablet\] /Reference \[suspension\]) and 90% CI for the ratio.

Maximum Plasma Concentration (Cmax) of Tablet Formulation and Suspension in PART-3: rBA/FE
Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, and 48 hours post-dose

Cmax is maximum plasma concentration. It was observed directly from data. Natural log transformed Cmax for PF-07321332 was analyzed to provide an estimate of the ratio of adjusted geometric means (Test \[tablet\] /Reference \[suspension\]) and 90% CI for the ratio.

Total Percent Recovery of Drug-Related Material in Urine in PART-4: ME
Day 1 to Day 11

Total recovery of drug-related material excreted in urine, expressed as a percent of total dose administered, measured by fluorine-19 nuclear magnetic resonance (19F-NMR).

Total Percent Recovery of Drug-Related Material in Feces in PART-4: ME
Day 1 to Day 11

Total recovery of drug-related material excreted in feces, expressed as a percent of total dose administered, measured by 19F-NMR.

Total Percent Recovery of Drug-Related Material in Excreta (Urine and Feces Combined) in PART-4: ME
Day 1 to Day 11

Total recovery of drug-related material excreted in urine and feces combined, expressed as a percent of total dose administered, measured by 19F-NMR.

Number of Participants With TEAEs in PART-5: SE
Post first dose till up to 36 days after last dose of study intervention

An 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 those with initial onset or increasing in severity between the first dose of study intervention and up to 36 days after last dose of study intervention. An 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. SAEs were adjudicated according to the investigator's assessment. Treatment-related AEs and SAEs were determined by the investigator.

Number of Participants With Clinically Significant Change From Baseline in Vital Signs in PART-5: SE
Baseline up to Day 5 of the final period

Vital signs (temperature, respiratory rate, PR, SBP, DBP) were obtained with participants following at least 5 minutes of supine rest. Categorical criteria were defined as DBP: value \<50 mm Hg, increase \>=20 mm Hg, or decrease \>=20 mm Hg; PR: value \<40 bpm or value \>120 bpm; SBP: value \<90 mm Hg, increase \>=30 mm Hg, or decrease \>=30 mm Hg. Clinical significance of vital signs was determined at the investigator's discretion.

Number of Participants With Laboratory Abnormalities in PART-5: SE
Baseline up to Day 5 of the final period

Laboratory parameters included hematology, chemistry, urinalysis, and other (urine drug screening, SARS-CoV-2 RT-PCR, eGFR, pregnancy test \[b-hCG\], aPTT, PT-INR, fibrinogen, TSH, Free T4). The clinical significance of laboratory parameters was determined at the investigator's discretion. The analysis population included all participants who received at least 1 dose of the study intervention.

Secondary Endpoints

Cmax of Plasma PF-07321332 in PART-1: SAD
Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Time for Cmax (Tmax) of Plasma PF-07321332 in PART-1: SAD
Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
AUClast of Plasma PF-07321332 in PART-1: SAD
Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
PF-07321332 Dose 1EXPERIMENTALDose level 1 of PF-07321332
PF-07321332 Dose 2EXPERIMENTALDose level 2 of PF-07321332
PF-07321332 Dose 3EXPERIMENTALDose level 3 of PF-07321332
PF-07321332 Dose 4EXPERIMENTALDose level 4 of PF-07321332
PF-07321332 Dose 5EXPERIMENTALDose level 5 of PF-07321332
PF-07321332 Dose 4 (Fed)EXPERIMENTALDose level 4 of PF-07321332 with high fat meal

Interventions

NameTypeDescription
PF-07321332 Dose 1DRUGPF-07321332 Dose 1 or Placebo
PF-07321332 Dose 2DRUGPF-07321332 Dose 2 or Placebo
PF-07321332 Dose 3DRUGPF-07321332 Dose 3 or Placebo
PF-07321332 Dose 4DRUGPF-07321332 Dose 4 or Placebo
PF-07321332 Dose 5DRUGPF-07321332 Dose 5 or Placebo
PF-07321332 Dose 4 or Placebo (Fed)DRUGPF-07321332 Dose 5 or Placebo with high fat meal
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Healthy male or female subjects between ages of 18-60 years. Male only in part-4. * Body Mass Index (BMI) of 17.5 to 30.5kg/m2; and a total body weight \>50kg (110lbs) * Japanese subjects who have four Japanese biologic grandparents born in Japan Exclusion Criteria: * Eviden...

Countries:United StatesBelgium
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Frequently asked questions about PF-07321332 Dose 1

What is PF-07275315 used for?

PF-07275315 is an investigational small molecule being studied for moderate to severe atopic dermatitis, moderate to severe chronic obstructive pulmonary disease, and non-small cell lung cancer. It is also being evaluated in healthy volunteers. The drug is in Phase 2 clinical development and is not approved by the FDA.

What does PF-07275315 target?

PF-07275315 targets the cytokines IL-4, IL-13, and TSLP. These are signaling proteins involved in inflammatory and immune responses. By targeting these cytokines, the drug is being studied for its potential effects in conditions like atopic dermatitis and chronic obstructive pulmonary disease.

Who makes PF-07275315?

PF-07275315 is being developed by Pfizer, Inc., which trades under the ticker symbol PFE on the New York Stock Exchange. The company is conducting clinical trials to evaluate the drug's safety and efficacy in several indications.

What phase is PF-07275315 in?

PF-07275315 is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. Clinical trials are ongoing to assess its safety and effectiveness in treating atopic dermatitis and chronic obstructive pulmonary disease.

What clinical trials is PF-07275315 in?

PF-07275315 is being studied in several clinical trials. NCT05995964 is a Phase 2 trial in moderate to severe atopic dermatitis. NCT07363694 is a Phase 2 trial in moderate to severe COPD. NCT06675188, a Phase 1 trial in healthy Chinese participants, has been completed.

Is PF-07275315 the same as sigvotatug vedotin?

Yes, PF-07275315 is also known as sigvotatug vedotin. The drug is referred to by both names in clinical research. It is being developed by Pfizer for multiple indications, including non-small cell lung cancer, where it is being studied under the name sigvotatug vedotin.