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

NCT03275740 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2024-07-05

Study results available
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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

  • Healthy
  • Primary Immune Thrombocytopenia
  • Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

DRUG

PF-06755347 intravenous healthy participant

Single doses of PF-06755347 will be administered intravenously dose levels 1, 2, 3, 4, 5, and 6.

DRUG

Placebo intravenous healthy participant

Placebo comparator

DRUG

PF-06755347 subcutaneous healthy participant

single doses of PF-06755347 will be administered subcutaneously at dose levels of SC1, SC2, SC3, SC4, and SC5.

DRUG

Placebo subcutaneous healthy participant

placebo comparator

DRUG

PF-06755347 subcutaneous ITP

single doses of PF-06755347 will be administered subcutaneously at 2 dose levels tested in healthy participants

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-17
Primary Completion
2023-01-06
Completion
2023-01-06
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • New Zealand
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03275740 on ClinicalTrials.gov