---
title: A Study Evaluating The Safety Of PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-06)
nct_id: NCT02015156
overall_status: COMPLETED
phase: PHASE1
sponsor: Pfizer
study_type: INTERVENTIONAL
primary_condition: Healthy
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02015156.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02015156"
ct_last_update_post_date: 2014-04-23
last_seen_at: "2026-05-12T06:22:43.814Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study Evaluating The Safety Of PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-06)

**Official Title:** Phase 1, Double-Blind, Randomized, Parallel-Group, Single-Dose, 2-Arm, Safety Study Of PF-05280014 And Trastuzumab Sourced From The US Administered To Healthy Male Volunteers

**NCT ID:** [NCT02015156](https://clinicaltrials.gov/study/NCT02015156)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 162
- **Lead Sponsor:** Pfizer
- **Conditions:** Healthy
- **Start Date:** 2014-01
- **Completion Date:** 2014-04
- **CT.gov Last Update:** 2014-04-23

## Brief Summary

This study is to prove that there is no difference in the number of healthy male volunteers that will experience pyrexia (i.e. fever with body temperature of 38°C or higher) within a 24 hour period after administration of a single dose of 6mg/kg of PF-05280014 or trastuzumab sourced from the United States (trastuzumab-US). The study will also compare the safety of both drugs.

## Detailed Description

Safety evaluation.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 55 Years
- **Sex:** MALE
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Body Mass Index (BMI) of 17.5 to 30.5 kg\^m2; and a total body weight \>50 kg (110 lbs).
* Left ventricular ejection fraction (LVEF) within the normal range as measured by echocardiogram (ECHO) within 8 weeks prior to randomization.
* Subjects who have previously been exposed to a biologic agent (other than a HER2 inhibitor) may enroll provided that at least 3 months have passed since the last administration of that drug.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Previous exposure to an anti-HER2 antibody.
* History of serious allergic or anaphylactic reaction to a therapeutic drug or benzyl alcohol.
```

## Arms

- **PF-05280014** (EXPERIMENTAL)
- **Trastuzumab-US** (ACTIVE_COMPARATOR)

## Interventions

- **PF-05280014** (BIOLOGICAL) — Concentrate for solution for infusion, sterile vial 150 mg, single-dose 6 mg/kg administered as 90-minute infusion on Day 1
- **Herceptin®** (BIOLOGICAL) — Concentrate for solution for infusion, sterile vial 440 mg, single-dose 6 mg/kg administered as 90-minute infusion on Day 1

## Primary Outcomes

- **Incidence of body temperature greater than or equal to 38.0 degrees Celsius** _(time frame: within 24 hours)_

## Secondary Outcomes

- **Incidence of pyrexia** _(time frame: within 24 hours)_
- **Severity of pyrexia** _(time frame: within 24 hours)_
- **Timing of pyrexia** _(time frame: within 24 hours)_
- **Seriousness of pyrexia** _(time frame: within 24 hours)_
- **Relationship of study therapy to pyrexia** _(time frame: within 24 hours)_
- **Incidence of body temperature greater than or equal to 38.0°C and/or use of concomitant treatment associated with fever suppression** _(time frame: within 24 hours)_

## Locations (2)

- Pfizer Investigational Site, Overland Park, Kansas, United States
- Pfizer Investigational Site, Overland Park, Kansas, United States

## 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|overland park|kansas|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02015156.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02015156*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*