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

Ascending Single Dose Study Of The Safety, Tolerability, And Pharmacokinetics Of PF-05230905 Administered Subcutaneously Or Intravenously To Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01284036

Acronym

FIH

Enrollment

Registered

2011-01-26

Start date

2010-10-31

Completion date

2011-11-30

Last updated

2013-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy subject, safety, PK study, healthy volunteers

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

Interventions

DRUGPF-05230905

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026