A Single Dose Clinical Trial to Study the Safety, Tolerability, and Pharmacokinetics of Intravenous MK-8226 in Healthy Subjects

Completed

• Conditions: Atopic Dermatitis; Inflammatory and Immune System - Other inflammatory or immune system disorders; Skin - Dermatological conditions

• Registration Number: ACTRN12612000375853
• Lead Sponsor: Merck Sharp and Dohme Corp, a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Subject judged to be in good health based on medical history, physical examination, ECG, vital sign measurements and laboratory safety tests
-Non-smoker
-BMI <30kg/m2

Exclusion Criteria

-Mentally or legally incapacitated or having significant emotional problems or has a history of clinically significant psychiatric disorder
-History of any clinically significant diseases/disorders
-Creatinine Clearance <80mL/min
-History of neoplastic disease
-Pregnant, breast feeding or expecting to conceive
-Major surgery or blood donation within 4 weeks
-Consumes excessive amounts of alcohol or caffeine
-History of significant allergies
-Regular/recreational drug user
-Participated in another clinical study within 4 weeks
-Positive to Hepatitis B, C or HIV
-Recent history of serious infection/infection requiring systemic antibiotics
-Received a live virus vaccine within 4 weeks.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of subjects experiencing at least one adverse event, as determined by the investigator via continuous monitoring of study participants and by repeated clinical and laboratory measures including ECG, Vital Signs and laboratory blood tests.[Time Frame: continuously monitored up to 98 days post treatment];Proportion of subjects with clinically significant ECG and vital signs abnormalities[Time Frame: <br>ECG: 24 hrs post treatment (Day 2), Days 7, 14, 21, 56, 84 and 98.<br>Vitals Signs:2, 3, 6, 12 hrs post treatment (Day 1); 24, and 48 hrs post treatment (Days 2 and 3); Days 7, 14, 21, 42, 56, 70, 84 and 98.];Proportion of subjects with clinically significant laboratory abnormalities from hematology, chemistry, and urinalysis tests.[Time Frame: 24 hrs post treatment (Day 2), Days 7, 14, 21, 84 and 98.]