A Phase 1 Study To Evaluate The Safety, Tolerability, Immunogenicity, Pharmacokinetics And Pharmacodynamics Of Escalating Doses Of Pf-06342674 (RN168) In Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- PF-06342674 Dose J
- Conditions
- Healthy
- Sponsor
- Pfizer
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Changes from baseline in safety laboratory assessments
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of single escalating doses PF-06342674.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male subjects and female of non-childbearing potential subjects between the ages of 18 and
- •BMI between 18.5 to 32 kg/m
- •Total body weight ≥40 kg and ≤120 kg.
Exclusion Criteria
- •Previous treatment with an antibody within 6 months prior to Day
- •Pregnant or nursing females; females of childbearing potential.
- •History of sensitivity to heparin or heparin-induced thrombocytopenia.
Arms & Interventions
2.0
Intervention: PF-06342674 Dose J
2.0
Intervention: PF-06342674 Dose F
1. Placebo
Placebo
Intervention: Placebo
2.0
Intervention: PF-06342674 Dose A
2.0
Intervention: PF-06342674 Dose B
2.0
Intervention: PF-06342674 Dose C
2.0
Intervention: PF-06342674 Dose D
2.0
Intervention: PF-06342674 Dose E
2.0
Intervention: PF-06342674 Dose G
2.0
Intervention: PF-06342674 Dose H
2.0
Intervention: PF-06342674 Dose I
Outcomes
Primary Outcomes
Changes from baseline in safety laboratory assessments
Time Frame: 60 days
Abnormal and clinically relevant changes in vital signs, blood pressure, and ECG parameters
Time Frame: 60 days
Incidence of anti-drug-antibodies
Time Frame: 60 days
Severity of treatment emergent AEs
Time Frame: 60 days
Causal relationship of treatment emergent AEs
Time Frame: 60 days
Incidence of dose limiting or intolerable treatment related AEs
Time Frame: 60 days
Incidence of treatment emergent AEs
Time Frame: 60 days
Incidence of abnormal laboratory findings
Time Frame: 60 days
Secondary Outcomes
- Area under the Concentration-Time Curve (AUC)(60 days)
- Maximum Observed Plasma Concentration (Cmax)(60 days)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(60 days)
- PK parameter estimates including T1/2.(60 days)
- Systemic Clearance (CL)(60 days)
- Apparent Oral Clearance (CL/F)(60 days)
- Apparent Volume of Distribution (Vz/F)(60 days)