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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03599063
• Collaborator: (none)
• Enrollment: 63
• Location: 1
• Arms: 8
• Actual Duration (Months): 13.6
• Patients Per Site Per Month: 4.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Biological: PF-06946860; Other: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 63 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Basic Science
• Official 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
• Actual Study Start Date: Jul 30, 2018
• Actual Primary Completion Date: Sep 18, 2019
• Actual Study Completion Date: Sep 18, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 Single subcutaneous administration of PF-06946860 at planned dose level 0.1 mg, or placebo	Biological: PF-06946860; PF-06946860 administered subcutaneously; Other: Placebo; Placebo, administered subcutaneously
Experimental: Cohort 2 Single subcutaneous administration of PF-06946860 at planned dose level 0.3 mg, or placebo	Biological: PF-06946860; PF-06946860 administered subcutaneously; Other: Placebo; Placebo, administered subcutaneously
Experimental: Cohort 3 Single subcutaneous administration of PF-06946860 at planned dose level 1 mg, or placebo	Biological: PF-06946860; PF-06946860 administered subcutaneously; Other: Placebo; Placebo, administered subcutaneously
Experimental: Cohort 4 Single subcutaneous administration of PF-06946860 at planned dose level 3 mg, or placebo	Biological: PF-06946860; PF-06946860 administered subcutaneously; Other: Placebo; Placebo, administered subcutaneously
Experimental: Cohort 5 Single subcutaneous administration of PF-06946860 at planned dose level 10 mg, or placebo	Biological: PF-06946860; PF-06946860 administered subcutaneously; Other: Placebo; Placebo, administered subcutaneously
Experimental: Cohort 6 Single subcutaneous administration of PF-06946860 at planned dose level 30 mg, or placebo	Biological: PF-06946860; PF-06946860 administered subcutaneously; Other: Placebo; Placebo, administered subcutaneously
Experimental: Cohort 7 Single subcutaneous administration of PF-06946860 at planned dose level 100 mg, or placebo	Biological: PF-06946860; PF-06946860 administered subcutaneously; Other: Placebo; Placebo, administered subcutaneously
Experimental: Optional: Cohort 8 Optional: single subcutaneous administration of PF-06946860 at planned dose level 30 mg, or placebo in healthy Japanese subjects	Biological: PF-06946860; PF-06946860 administered subcutaneously; Other: Placebo; Placebo, administered subcutaneously

Outcome Measures

Primary Outcome Measures

1. Incidence of participants experiencing AE. [Up 9 weeks post dose]

Secondary Outcome Measures

1. Maximum Observed Plasma Concentration (Cmax) [Baseline, up to 9 weeks post dose, as data permit]

2. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [Baseline, up to 9 weeks post dose, as data permit]

3. Time to Reach Maximum Observed Plasma Concentration (Tmax) [Baseline, up to 9 weeks post dose, as data permit]

4. Plasma Decay Half-Life (t1/2) [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 [Baseline, up to 9 weeks post-dose, as data permit]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer New Haven Clinical Research Unit	New Haven	Connecticut	United States	06511

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT03599063
• Other Study ID Numbers: C3651001; FIH
• First Posted: Jul 26, 2018
• Last Update Posted: Nov 8, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 8, 2019