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Evaluation of the Pharmacokinetics, Safety and Tolerability of Single Dose of PF-06480605 in Chinese Healthy Participants

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT05107492
Collaborator
(none)
12
Enrollment
1
Location
2
Arms
4.6
Actual Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 1, single-center, randomized, double-blind, third-party open (ie, participant blind, investigator blind and sponsor open), placebo controlled study to investigate PK, safety, tolerability, immunogenicity, and PD of PF 06480605 following a single subcutaneous dose of PF-06480605 450 mg and 150 mg (if needed) in Chinese healthy adult participants.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY OPEN, PLACEBO-CONTROLLED STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY FOLLOWING SINGLE SUBCUTANEOUS DOSE OF PF-06480605 IN CHINESE HEALTHY PARTICIPANTS
Actual Study Start Date :
Nov 19, 2021
Actual Primary Completion Date :
Apr 9, 2022
Actual Study Completion Date :
Apr 9, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1

12 participants will be randomly assigned at an allocation ratio of 3:1 to the active treatment 450mg and placebo arms.

Drug: 450mg
following a single subcutaneous dose of PF-06480605 450 mg

Drug: Placebo
following a single subcutaneous dose of placebo
Experimental: Cohort 2

12 participants will be randomly assigned at an allocation ratio of 3:1 to the active treatment 150mg and placebo arms.

Drug: 150mg
following a single subcutaneous dose of PF-06480605 150 mg

Drug: Placebo
following a single subcutaneous dose of placebo

Outcome Measures

Primary Outcome Measures

  1. Maximum Observed Plasma Concentration (Cmax) [Day 1 to Day 114]

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax) [Day 1 to Day 114]

  3. Area Under the Curve From Time Zero to End of Dosing Interval (AUC 14 days)) [Day 1 to Day 14]

  4. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) [Day 1 to Day 114]

  5. Plasma Decay Half-Life (t1/2) [Day 1 to Day 114]

  6. Number of Participants with Adverse Events (AEs) [Day 1 to Day 114]

  7. Number of Participants with abnormal vital signs [Day 1 to Day 114]

  8. Number of Participants with abnormal 12 lead electrocardiograms [Day 1 to Day 114]

  9. Number of Participants with abnormal physical examination findings [Day 1 to Day 114]

  10. Number of Participants with abnormal clinical safety laboratory measurements [Day 1 to Day 114]

Secondary Outcome Measures

  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [Day 1 to Day 114]

  2. Cmax(dn) [Day 1 to Day 114]

  3. AUCinf(dn) [Day 1 to Day 114]

  4. Apparent Volume of Distribution (Vz/F) [Day 1 to Day 114]

  5. Apparent Oral Clearance (CL/F) [Day 1 to Day 114]

  6. Incidence of the development of ADA and NAb. [Day 1 to Day 114]

  7. Total sTL1A protein concentration in serum. [Day 1 to Day 114]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Male and female participants must be 18 to 45 years of age, inclusive, at the time of signing the ICD.

  • Male and female Chinese participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital sign and 12-lead ECG

  • BMI of 19 to 27 kg/m2; and a total body weight >50 kg.

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, hepatitis B, hepatitis C or syphilis; positive testing for HIV, hepatitis B, HCVAb or serological reaction of syphilis.

  • History of allergic or anaphylactic reaction to a therapeutic drug.

  • History of recent active infections within 28 days prior to the screening visit.

  • Participants with a fever within 48 hours prior to dosing.

  • History of TB or active or latent or inadequately treated infection.

  • Recent exposure to live vaccines within 28 days of the screening visit.

  • A positive pregnancy test.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University Third Hospital Beijing Beijing China 100191

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT05107492
Other Study ID Numbers:
  • B7541013
First Posted:
Nov 4, 2021
Last Update Posted:
Jul 11, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pfizer
IBD
PK
Additional relevant MeSH terms:
Inflammatory Bowel Diseases

Study Results

No Results Posted as of Jul 11, 2022