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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000375853

Enrollment

Registered

2012-04-02

Start date

2012-04-17

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A study to evaluate the safety, tolerability and metabolism of MK8226 in healthy volunteers. MK8226 is being developed for treatment of patients with moderate to severe atopic dermatitis. However, this study is in healthy volunteers only.

Interventions

Panel A: MK-8226 0.1 mg/kg single IV dose Panel B: MK-8226 0.3 mg/kg single IV dose Panel C: MK-8226 1 mg/kg single IV dose Panel D: MK-8226 3 mg/kg single IV dose Panel E: MK-8226 10 mg/kg single IV dose In each of the panels above, participants will be randomised to receive either the dose level described for the specific panel or placebo. MK8226 is being developed for treatment of patients with moderate to severe atopic dermatitis. However, this study is in healthy volunteers only.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Outcome results