A Phase 1 Ascending Single Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-05230901 Administered Subcutaneously To Healthy Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Pfizer
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Incidence and severity of adverse events.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Dose
6 treated, 3 placebos
Intervention: PF-05230901 (Drug)
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(14 days)
- Anti-drug antibodies(35 days)
- Appetite and food consumption(13 days)