Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Intravenous and Multiple Subcutaneous and Intravenous Doses of PF-06480605 in Healthy Subjects.

NCT01989143 | Completed Phase 1

• 1 other identifier: B7541001
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

This single and multiple ascending dose study is a first in human assessment of PF-06480605. The goal is to study the safety, tolerability, pharmacokinetics and pharmacodynamics.

Conditions

Healthy

Keywords

Phase 1; Randomized; Double-blind; Placebo-controlled; Dose escalating; Single and Multiple doses; Safety; Tolerability; PK/PD; PF-06480605

Outcome Measures

Primary Outcomes (4)

• Incidence of dose limiting or intolerability treatment related adverse events (AEs).

  6 weeks

• Incidence, severity and causal relationship of treatment emergent AEs (TEAEs) and withdrawals due to treatment emergent adverse events.

  6 weeks

• Incidence and magnitude of abnormal laboratory findings.

  6 weeks

• Abnormal and clinically relevant changes in vital signs, blood pressure (BP) and electrocardiogram (ECG) parameters.

  6 weeks

Secondary Outcomes (39)

• Single Ascending Dose: Maximum Observed Plasma Concentration (Cmax)

  6 weeks

• Single Ascending Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)

  6 weeks

• Single Ascending Dose: Area under the plasma concentration-time profile from time zero to 14 days (AUC14 days)

  6 weeks

• Single Ascending Dose: Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)

  6 weeks

• Single Ascending Dose: Area under the plasma concentration-time profile from time zero to the time of last quantifiable concentration (AUClast)

  6 weeks

Study Arms (6)

SAD Cohorts 1-8 Experimental Arm

EXPERIMENTAL

Drug: PF-06480605

SAD Cohorts 1-8 Placebo Arm

PLACEBO COMPARATOR

Drug: Placebo

MAD Cohorts 9-11 Experimental Arm

EXPERIMENTAL

Drug: PF-06480605

MAD Cohorts 9-11 Placebo Arm

PLACEBO COMPARATOR

Drug: Placebo

MAD Cohort 12 Experimental Arm

EXPERIMENTAL

Drug: PF-06480605

MAD Cohort 12 Placebo Arm

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PF-06480605 DRUG

Subjects will receive single intravenous doses of 1, 3, 10, 30, 100, 300, 600 or 800 mg of PF-06480605 solution in a dose escalation format.

SAD Cohorts 1-8 Experimental Arm

Placebo DRUG

Subjects will receive single intravenous doses of PF-06480605 matching placebo solution in a dose escalation format.

SAD Cohorts 1-8 Placebo Arm

Eligibility Criteria

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

You may qualify if:

• Healthy male and/or female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive (Healthy is defined as no 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).
• Female subjects of non childbearing potential must meet at least one of the following criteria:
• Achieved postmenopausal status, defined as: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal females;
• Have undergone a documented hysterectomy and/or bilateral oophorectomy;
• Have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) will be considered to be of childbearing potential.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
• Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
• X-ray with no evidence of current, active TB or previous inactive TB, general infections, heart failure, malignancy, or other clinically significant abnormalities taken at Screening or within 3 months prior to Day 1 and read by a qualified radiologist.

You may not qualify if:

• 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).
• Subjects with a history of or current positive results for any of the following serological tests: Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), anti Hepatitis C antibody (HCV Ab) or human immunodeficiency virus (HIV).
• Subjects with a history of autoimmune disorders.
• Subjects with a history of allergic or anaphylactic reaction to a therapeutic drug.
• History of tuberculosis or active, latent or inadequately treated tuberculosis infection.
• Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half lives or 180 days for biologics preceding the first dose of study medication.
• Pregnant females; breastfeeding females; and females of childbearing potential.

Sponsors & Collaborators

• Telavant, Inc.: lead
• Pfizer: collaborator

Study Sites (1)

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

• Banfield C, Rudin D, Bhattacharya I, Goteti K, Li G, Hassan-Zahraee M, Brown LS, Hung KE, Pawlak S, Lepsy C. First-in-human, randomized dose-escalation study of the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of PF-06480605 in healthy subjects. Br J Clin Pharmacol. 2020 Apr;86(4):812-824. doi: 10.1111/bcp.14187. Epub 2020 Jan 28.

  PMID: 31758576 DERIVED

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2013
• First Posted: November 20, 2013
• Study Start: December 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: October 19, 2023

Record last verified: 2023-10

Locations

US (1)