A Study In Healthy Subjects Of Single Doses of PF-05230901 Injected Under The Skin

Phase 1TerminatedNCT01262690

Pfizer44 enrolled

Overview

This study will examine whether a single dose of PF-05230901 is safe and well tolerated when given to healthy volunteers by injection under the skin. An additional objective is to measure the blood concentrations of PF-05230901. Each dose will be tested in a different group of subjects starting from the lowest dose.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cachexia

Interventions

PF-05230901DRUG

Single ascending doses of PF-05230901 in separate cohorts of subjects; each cohort consists of 6 subjects treated with PF-05230901 and 3 subjects treated with placebo.

PF-05230901DRUG

Single dose SC

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy subjects Exclusion Criteria: * History of seizures, including childhood seizures. * History of movement disorders or related neurological conditions. * History of head trauma associated with loss of consciousness.

Locations (1)

Pfizer Investigational Site

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Incidence and severity of adverse events.

Time frame: 35 days

Incidence and severity of clinical laboratory abnormalities.

Time frame: 35 days

Mean change from baseline in vital signs.

Time frame: 35 days

Mean change from baseline in 12-lead electrocardiogram (ECG) parameters.

Time frame: 35 days

Incidence and severity of findings during the neurological examination.

Time frame: 35 days

Secondary Outcomes

Plasma concentrations

Time frame: 14 days

Anti-drug antibodies

Time frame: 35 days

Appetite and food consumption

Time frame: 13 days

Data from ClinicalTrials.gov

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