A Single Dose Study Of The Safety And Investigational Product Level Measurement In Healthy Subjects (FIH)

Ablynx

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-05230905

Study type: Interventional

Funder types: Industry

Identifiers

NCT01284036

B2331001

3294K1-1000

Details and patient eligibility

About

The purpose of this study is to find the safety and side effects of investigational drug in healthy volunteers. See how quickly investigational drug enters the bloodstream, is distributed in the body, broken down and removed in healthy male and female volunteers. See if your body makes antibodies to this investigational drug (how your immune system responds).

Full description

First in human study to collect safety and pharmacokinetics (PK) of single ascending dose in Healthy subjects

Enrollment: 63 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and/or female subjects between the ages of 18 and 55 years.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion criteria

• Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
• Receipt or treatment with an investigational or marketed biologic drug.
• blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.

Trial design

63 participants in 1 patient group

PF-05230905

Other group

Description:

9 subjects will participate in each dose cohort. 6 subjects will receive investigational product (PF-05230905) and 3 subjects will receive placebo

Treatment:

Drug: PF-05230905