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

NCT01284036 | Completed Phase 1

• 2 other identifiers: B23310013294K1-1000
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Keywords

Healthy subject; safety; PK study; healthy volunteers

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

Study Arms (1)

PF-05230905

OTHER

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

Drug: PF-05230905

Interventions

PF-05230905 DRUG

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

PF-05230905

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ablynx, a Sanofi company: lead

Study Sites (1)

Investigational Site

Tacoma, Washington, 98418, United States

Location

Study Officials

• Josefin-Beate Holz, MD

  Ablynx, a Sanofi company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2010
• First Posted: January 26, 2011
• Study Start: October 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: January 31, 2013

Record last verified: 2013-01

Locations

US (1)