Clinical Trials Directory

Trials / Terminated

TerminatedNCT03275740

A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO -CONTROLLED, FIRST-IN-HUMAN TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PF 06755347 AFTER SINGLE ASCENDING INTRAVENOUS AND SUBCUTANEOUS DOSING IN HEALTHY ADULT MALE PARTICIPANTS AND OPEN-LABEL AFTER SINGLE SUBCUTANEOUS DOSING IN MALE AND FEMALE PARTICIPANTS WITH PERSISTENT OR CHRONIC PRIMARY IMMUNE THROMBOCYTOPENIA

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
58 (actual)
Sponsor
Pfizer · Industry
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Accepted

Summary

This phase 1 single ascending dose study will provide a first in human assessment of safety and tolerability of PF-06755347 in healthy adult males as well as adult males and females with Immune Thrombocytopenia (ITP). Pharmacokinetics and pharmacodynamics will also be evaluated.

Conditions

Interventions

TypeNameDescription
DRUGPF-06755347 intravenous healthy participantSingle doses of PF-06755347 will be administered intravenously dose levels 1, 2, 3, 4, 5, and 6.
DRUGPlacebo intravenous healthy participantPlacebo comparator
DRUGPF-06755347 subcutaneous healthy participantsingle doses of PF-06755347 will be administered subcutaneously at dose levels of SC1, SC2, SC3, SC4, and SC5.
DRUGPlacebo subcutaneous healthy participantplacebo comparator
DRUGPF-06755347 subcutaneous ITPsingle doses of PF-06755347 will be administered subcutaneously at 2 dose levels tested in healthy participants

Timeline

Start date
2017-07-17
Primary completion
2023-01-06
Completion
2023-01-06
First posted
2017-09-08
Last updated
2024-07-05
Results posted
2024-07-05

Locations

6 sites across 5 countries: United States, Belgium, New Zealand, Spain, United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT03275740. Inclusion in this directory is not an endorsement.