Skip to main content
OpenTrials
Completed

NCT Number: NCT03599063

Singe Dose, First in Human Study of PF- 06946860 in Healthy Adult Subjects

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of PF-06946860 in healthy adult subjects following single ascending doses This is the first clinical study of PF-06946860.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Healthy female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive
  • Body mass index (BMI) within 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
  • Subjects enrolling as Japanese must have four biologically Japanese grandparents born in Japan.

Key Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing.
  • History of allergic reactions to diagnostic or therapeutic protein or human albumin.
  • History of recurrent infections or active infection within 28 days of screening.
  • Exposure to live vaccines within 28 days of screening.
  • History of regular alcohol consumption or positive drug test
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of IP (whichever is longer).
  • Fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 28 days after the last dose.
  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose

Treatment and study plan

PF-06946860

Biological

PF-06946860 administered subcutaneously

Placebo

Other

Placebo, administered subcutaneously

Primary outcomes

  1. Incidence of participants experiencing AE.

    Time frame: Up 9 weeks post dose

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Baseline, up to 9 weeks post dose, as data permit

  2. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    Time frame: Baseline, up to 9 weeks post dose, as data permit

  3. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: Baseline, up to 9 weeks post dose, as data permit

  4. Plasma Decay Half-Life (t1/2)

    Time frame: Baseline, up to 9 weeks post dose, as data permit

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  5. Incidence of development of ADA, and if necessary NAb, against PF-06946860

    Time frame: Baseline, up to 9 weeks post-dose, as data permit

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 1, RANDOMIZED, DOUBLE BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE-DOSE, SUBCUTANEOUS ADMINISTRATION OF PF 06946860 TO HEALTHY ADULT SUBJECTS

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 26, 2018
Registry last updated
Nov 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.