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

Ablynx, a Sanofi company63 enrolled

Overview

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).

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

Study Type

INTERVENTIONAL

Allocation

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

PF-05230905DRUG

Single dose subcutaneous or intravenous (IV) administration of PF-05230905 or placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Investigational Site

Tacoma, Washington, United States

Outcomes

Primary Outcomes

Safety endpoints will be evaluated by comparing reported adverse events in subjects receiving PF-05230905 versus subjects receiving placebo.

Time frame: day 168

Incidence and severity of clinical laboratories including absolute hepatic transaminases and bilirubin levels will be evaluated.

Time frame: day 168

Mean change from baseline in vital signs measurements. Mean change from baseline in 12 lead echocardiogram (ECG) will be compared to ensure safety of the subjects.

Time frame: day 168

Secondary Outcomes

Incidence of development of Anti Drug Antibody.

Time frame: day 168

Serum PF-05230905 concentrations will be determined by a validated assay, and noncompartmental pharmacokinetics (PK) parameters.

Time frame: day 168

Urine pharmacokinetics (PK) parameters amount excreted in urine (Ae) and renal clearance will be determined.

Time frame: day 168

Data from ClinicalTrials.gov

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