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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-05230905

• Registration Number: NCT01284036
• Lead Sponsor: Ablynx, a Sanofi company

Brief Summary

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).

Detailed Description

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

Study Timeline

• Study First Submitted: 2010-09-29
• Study Start: 2010-10
• Study First Submitted QC: 2011-01-25
• Study First Posted: 2011-01-26
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-30
• Last Update Posted: 2013-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Safety endpoints will be evaluated by comparing reported adverse events in subjects receiving PF-05230905 versus subjects receiving placebo.	day 168
Incidence and severity of clinical laboratories including absolute hepatic transaminases and bilirubin levels will be evaluated.	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.	day 168

Secondary Outcome Measures

Name	Time	Method
Incidence of development of Anti Drug Antibody.	day 168
Serum PF-05230905 concentrations will be determined by a validated assay, and noncompartmental pharmacokinetics (PK) parameters.	day 168
Urine pharmacokinetics (PK) parameters amount excreted in urine (Ae) and renal clearance will be determined.	day 168

Trial Locations

Locations (1)

Investigational Site; 🇺🇸 Tacoma, Washington, United States