A Study To Assess The Safety Of PF-06342674 In Healthy Volunteers

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of single escalating doses PF-06342674.

Official Title
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A Phase 1 Study To Evaluate The Safety, Tolerability, Immunogenicity, Pharmacokinetics And Pharmacodynamics Of Escalating Doses Of Pf-06342674 (RN168) In Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Placebo
* Biological: PF-06342674 Dose A
* Biological: PF-06342674 Dose B
* Biological: PF-06342674 Dose C
* Biological: PF-06342674 Dose D
* Biological: PF-06342674 Dose E
* Biological: PF-06342674 Dose F
* Biological: PF-06342674 Dose G
* Biological: PF-06342674 Dose H
* Biological: PF-06342674 Dose I
* Biological: PF-06342674 Dose J


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male subjects and female of non-childbearing potential subjects between the ages of 18 and 55. BMI between 18.5 to 32 kg/m2. Total body weight ≥40 kg and ≤120 kg. Exclusion Criteria: Previous treatment with an antibody within 6 months prior to Day 1. Pregnant or nursing females; females of childbearing potential. History of sensitivity to heparin or heparin-induced thrombocytopenia.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1. Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|
| Experimental: 2.0<br> | Biological: PF-06342674 Dose A<br>* Single SC Dose<br>Biological: PF-06342674 Dose B<br>* Single SC Dose<br>Biological: PF-06342674 Dose C<br>* Single SC Dose<br>Biological: PF-06342674 Dose D<br>* Single SC Dose<br>Biological: PF-06342674 Dose E<br>* Single SC Dose<br>Biological: PF-06342674 Dose F<br>* Single IV Dose<br>Biological: PF-06342674 Dose G<br>* Single SC Dose<br>Biological: PF-06342674 Dose H<br>* Single IV Dose<br>Biological: PF-06342674 Dose I<br>* Single SC Dose<br>Biological: PF-06342674 Dose J<br>* Single IV Dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of dose limiting or intolerable treatment related AEs |  | 60 days | 
| Incidence of treatment emergent AEs |  | 60 days | 
| Incidence of abnormal laboratory findings |  | 60 days | 
| Changes from baseline in safety laboratory assessments |  | 60 days | 
| Abnormal and clinically relevant changes in vital signs, blood pressure, and ECG parameters |  | 60 days | 
| Incidence of anti-drug-antibodies |  | 60 days | 
| Severity of treatment emergent AEs |  | 60 days | 
| Causal relationship of treatment emergent AEs |  | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the Concentration-Time Curve (AUC) | AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. | 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) | CL is a quantitative measure of the rate at which a drug substance is removed from the body. | 60 days | 
| Apparent Oral Clearance (CL/F) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | 60 days | 
| Apparent Volume of Distribution (Vz/F) | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1, RN168, Healthy Volunteers