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

NCT03599063 | Completed Phase 1 FDA Drug

• 2 other identifiers: C3651001FIH
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Incidence of participants experiencing AE.

  Up 9 weeks post dose

Secondary Outcomes (5)

• Maximum Observed Plasma Concentration (Cmax)

  Baseline, up to 9 weeks post dose, as data permit

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

  Baseline, up to 9 weeks post dose, as data permit

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  Baseline, up to 9 weeks post dose, as data permit

• Plasma Decay Half-Life (t1/2)

  Baseline, up to 9 weeks post dose, as data permit

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

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

Study Arms (8)

Cohort 1

EXPERIMENTAL

Single subcutaneous administration of PF-06946860 at planned dose level 0.1 mg, or placebo

Biological: PF-06946860; Other: Placebo

Cohort 2

EXPERIMENTAL

Single subcutaneous administration of PF-06946860 at planned dose level 0.3 mg, or placebo

Biological: PF-06946860; Other: Placebo

Cohort 3

EXPERIMENTAL

Single subcutaneous administration of PF-06946860 at planned dose level 1 mg, or placebo

Biological: PF-06946860; Other: Placebo

Cohort 4

EXPERIMENTAL

Single subcutaneous administration of PF-06946860 at planned dose level 3 mg, or placebo

Biological: PF-06946860; Other: Placebo

Cohort 5

EXPERIMENTAL

Single subcutaneous administration of PF-06946860 at planned dose level 10 mg, or placebo

Biological: PF-06946860; Other: Placebo

Cohort 6

EXPERIMENTAL

Single subcutaneous administration of PF-06946860 at planned dose level 30 mg, or placebo

Biological: PF-06946860; Other: Placebo

Cohort 7

EXPERIMENTAL

Single subcutaneous administration of PF-06946860 at planned dose level 100 mg, or placebo

Biological: PF-06946860; Other: Placebo

Optional: Cohort 8

EXPERIMENTAL

Optional: single subcutaneous administration of PF-06946860 at planned dose level 30 mg, or placebo in healthy Japanese subjects

Biological: PF-06946860; Other: Placebo

Interventions

PF-06946860 BIOLOGICAL

PF-06946860 administered subcutaneously

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7; Optional: Cohort 8

Placebo OTHER

Placebo, administered subcutaneously

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7; Optional: Cohort 8

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: July 26, 2018
• Study Start: July 30, 2018
• Primary Completion: September 18, 2019
• Study Completion: September 18, 2019
• Last Updated: November 8, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)