Healthy
Conditions
Keywords
Phase 1, RN168, Healthy Volunteers
Brief summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of single escalating doses PF-06342674.
Interventions
DRUGPlacebo
Placebo
BIOLOGICALPF-06342674 Dose A
Single SC Dose
BIOLOGICALPF-06342674 Dose B
Single SC Dose
BIOLOGICALPF-06342674 Dose C
Single SC Dose
BIOLOGICALPF-06342674 Dose D
Single SC Dose
BIOLOGICALPF-06342674 Dose E
Single SC Dose
BIOLOGICALPF-06342674 Dose F
Single IV Dose
BIOLOGICALPF-06342674 Dose G
Single SC Dose
BIOLOGICALPF-06342674 Dose H
Single IV Dose
BIOLOGICALPF-06342674 Dose I
Single SC Dose
BIOLOGICALPF-06342674 Dose J
Single IV Dose
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Causal relationship of treatment emergent AEs | 60 days |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | CL is a quantitative measure of the rate at which a drug substance is removed from the body. |
| Apparent Oral Clearance (CL/F) | 60 days | 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. |
| Apparent Volume of Distribution (Vz/F) | 60 days | 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. |
| Area under the Concentration-Time Curve (AUC) | 60 days | AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. |
Countries
United States
Outcome results
None listed