PF-06755347 – first doses in humans, Version 1
Research type
Research Study
Full title
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 to healthy adult male participants. (20-003)
IRAS ID
283479
Contact name
Jay Janz
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2018-003315-21
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND 017473, United States Investigational New Drug (IND) Number
Duration of Study in the UK
1 years, 1 months, 1 days
Research summary
The study medicine (PF-06755347) is an experimental new medicine for treating patients with chronic inflammatory demyelinating polyneuropathy (CIDP), a rare but serious illness that causes severe damage to the nerves to many parts of the body; and primary immune thrombocytopenia (ITP), a rare blood disease where a patient is deficient in a type of blood cell (called ‘platelets’) needed for normal blood clotting. CIDP and ITP are currently treated with substances purified from plasma separated from the blood of healthy donors. These substances are called immunoglobulins (Ig) – proteins that help control inflammation. However, plasma from healthy donors is in short supply and Ig is not always well-tolerated. The study medicine is a pure form of a fragment of one type of Ig (IgG), made especially for administration to humans. We hope it will be as effective, better tolerated, and more available than plasma-derived Ig. So far, the study medicine has been well tolerated by healthy men at single, low doses in a centre in Belgium.
We’re doing this study to assess the safety, tolerability and blood levels of higher single doses of the study medicine, given by slow infusion into a vein or by injection or infusion under the skin of healthy adult men, to prepare the way for clinical trials in patients. Also, we’ll assess whether the body makes antibodies against the study medicine.
Participants will take about 11 weeks to complete the study. They’ll stay on the ward for 8 nights and make up to 9 outpatient visits.
A pharmaceutical company (Pfizer Inc.) is funding the study, which will take place at 2 centres: 1 in the UK and 1 in Belgium.
REC name
North East - York Research Ethics Committee
REC reference
20/NE/0180
Date of REC Opinion
12 Aug 2020
REC opinion
Favourable Opinion