---
title: A Clinical Study Evaluating The Safety And Tolerability Of PF-04427429 In Healthy Adult Volunteers. The Pharmacokinetics And Pharmacodynamics Of PF-04427429 Will Also Be Investigated
nct_id: NCT01165723
overall_status: COMPLETED
phase: PHASE1
sponsor: Pfizer
study_type: INTERVENTIONAL
primary_condition: Healthy
countries: Belgium
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01165723.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01165723"
ct_last_update_post_date: 2012-02-22
last_seen_at: "2026-05-12T06:11:57.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Clinical Study Evaluating The Safety And Tolerability Of PF-04427429 In Healthy Adult Volunteers. The Pharmacokinetics And Pharmacodynamics Of PF-04427429 Will Also Be Investigated

**Official Title:** A Randomised, Placebo Controlled, Double-Blind, Third Party Open, Parallel Group Study To Evaluate the Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Repeat Doses PF-04427429 Administered Intravenously To Healthy Adult Volunteers

**NCT ID:** [NCT01165723](https://clinicaltrials.gov/study/NCT01165723)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 21
- **Lead Sponsor:** Pfizer
- **Conditions:** Healthy
- **Start Date:** 2010-08
- **Completion Date:** 2012-01
- **CT.gov Last Update:** 2012-02-22

## Brief Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04472429 administered intravenously to healthy adult volunteers.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 50 Years
- **Sex:** MALE
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 50 years inclusive. (healthy is defined as non clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests)
* Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight of 50 to 100kg inclusive
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial

Exclusion Criteria:

* Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic or allergic disease (including drug allergies, but excluding untreated symptomatic, seasonal allergies at time of dosing)
* History of febrile illness within 5 days prior to the first dose
* A positive urine drug screen
```

## Arms

- **IV Dose 1: experimental** (EXPERIMENTAL)
- **IV Dose 2: experimental** (EXPERIMENTAL)

## Interventions

- **PF-04427429** (BIOLOGICAL) — Intravenous dosing of 30mg on day 1 and one other day to be determined up to day 30
- **PF-04427429** (BIOLOGICAL) — Intravenous dosing of 30mg on day 1 and one other day to be determined up to day 30

## Primary Outcomes

- **Safety (incidence/severity of adverse events and clinical laboratory abnormalities, mean change from baseline/placebo in vital signs/body temperature, mean change from baseline in 12 lead electrocardiogram parameters compared to baseline/placebo)** _(time frame: up to 129 days)_
- **Safety continued (categorical summary of QTcF compared to baseline between dose groups and placebo, concentration QTcF relationship, ADA responses, IV injection site reactions** _(time frame: up to 129 days)_
- **Pharmacokinetics (free plasma concentrations of PF-04427429 will be measured by a validated assay and non-compartmental PK parameters will be determined for each dose)** _(time frame: up to 129 days)_

## Secondary Outcomes

- **pharmacodynamics (free and total CGRP plasma concentration) will be measured, the PK-PD relationship between plasma PF-0447429 concentrations and free/total CGRP concentrations will be characterised** _(time frame: up to 129 days)_

## Locations (1)

- Pfizer Investigational Site, Brussels, Belgium

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.pfizer investigational site|brussels||belgium` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01165723.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01165723*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*