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

A Phase 1 Ascending Single Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-05230901 Administered Subcutaneously To Healthy Subjects

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01262690

Enrollment

Registered

2010-12-17

Start date

2010-11-30

Completion date

2011-09-30

Last updated

2011-10-12

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

Conditions

Cachexia

Keywords

First-in-human (FIH), Single Ascending Dose (SAD) Study, TAM-163, PF-05230901, Cachexia

Brief summary

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.

Interventions

DRUGPF-05230901

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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Incidence and severity of findings during the neurological examination.	35 days
Incidence and severity of clinical laboratory abnormalities.	35 days
Mean change from baseline in vital signs.	35 days
Mean change from baseline in 12-lead electrocardiogram (ECG) parameters.	35 days
Incidence and severity of adverse events.	35 days

Secondary

Measure	Time frame
Anti-drug antibodies	35 days
Appetite and food consumption	13 days
Plasma concentrations	14 days

Countries

United States

Outcome results

None listed

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