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A Study to Learn About Study Medicine Called PF-07261271 in Healthy People

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Pfizer

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Placebo
Drug: PF-07261271

Study type

Interventional

Funder types

Industry

Identifiers

NCT05536440
C4631001

Details and patient eligibility

About

The purpose of this clinical trial is to learn about the safety and effects of the study medicine PF-07261271 for the potential treatment of Inflammatory Bowel Disease.

Enrollment

35 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy individuals as determined by medical evaluation
  • Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

Exclusion criteria

  • Clinically significant medical conditions
  • History of HIV infection, hepatitis B, or hepatitis C
  • BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic)
  • Clinically relevant ECG abnormalities
  • Previous study drug administration within 30 days or 5 half-lives of first planned dose
  • History of drug/alcohol abuse or >20 cigarettes/day

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Double Blind

35 participants in 16 patient groups, including a placebo group

Cohort 1 active
Experimental group
Description:
Dose A
Treatment:
Drug: PF-07261271
Cohort 1 placebo
Placebo Comparator group
Description:
Dose A
Treatment:
Drug: Placebo
Cohort 2 active
Experimental group
Description:
Dose B
Treatment:
Drug: PF-07261271
Cohort 2 placebo
Placebo Comparator group
Description:
Dose B
Treatment:
Drug: Placebo
Cohort 3 active
Experimental group
Description:
Dose C
Treatment:
Drug: PF-07261271
Cohort 3 placebo
Placebo Comparator group
Description:
Dose C
Treatment:
Drug: Placebo
Cohort 4 active
Experimental group
Description:
Dose D
Treatment:
Drug: PF-07261271
Cohort 4 placebo
Placebo Comparator group
Description:
Dose D
Treatment:
Drug: Placebo
Cohort 5 active
Experimental group
Description:
Dose E
Treatment:
Drug: PF-07261271
Cohort 5 placebo
Placebo Comparator group
Description:
Dose E
Treatment:
Drug: Placebo
Cohort 6 active
Experimental group
Description:
Dose F
Treatment:
Drug: PF-07261271
Cohort 6 placebo
Placebo Comparator group
Description:
Dose F
Treatment:
Drug: Placebo
Cohort 7 active
Experimental group
Description:
Dose G
Treatment:
Drug: PF-07261271
Cohort 7 placebo
Placebo Comparator group
Description:
Dose G
Treatment:
Drug: Placebo
Cohort 8 active
Experimental group
Description:
Dose H
Treatment:
Drug: PF-07261271
Cohort 8 placebo
Placebo Comparator group
Description:
Dose H
Treatment:
Drug: Placebo

Trial documents
2

Trial contacts and locations

5

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Central trial contact

Pfizer CT.gov Call Center

Data sourced from clinicaltrials.gov

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