Status:
TERMINATED
A 6-Part Study In Healthy Volunteers To Evaluate Safety, Tolerability and Uptake Of MEDI7219 in the Body When Given as Single and Multiple Doses
Lead Sponsor:
MedImmune LLC
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a 6-part study to evaluate the safety, tolerability, and PK of MEDI7219 in healthy subjects. Parts A, B, C \& E are the single-dose parts of the study. Parts D \& F are the multiple ascending ...
Detailed Description
MEDI7219 is being developed for the potential treatment of type 2 diabetes. The study is a first in human, single and multiple ascending dose study that will try to identify the safety, tolerability a...
Eligibility Criteria
Inclusion
- Healthy volunteers age 18-55 years
- BMI 18-32 kg/m2
- Females not of childbearing potential
- Able and willing to adhere to the protocol
- Must provide written informed consent
Exclusion
- Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
- Abnormal lab values, physical exam, vital signs
- Positive drug or alcohol screen.
- Current enrollment in another clinical study or enrollment within the past 3 months
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to dosing
- Abnormal ECG
- Positive Hepatitis B, Hepatitis C or HIV test
- Positive Drug or Alcohol screen
- Current smokers or those who have smoked within the last 12 months
- Recent plasma or blood donation
- Evidence of current SARS-CoV-2 infection (Part E Cohort 5 and Part F Cohort 2 only)
Key Trial Info
Start Date :
December 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2020
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT03362593
Start Date
December 4 2017
End Date
May 11 2020
Last Update
August 31 2020
Active Locations (1)
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1
Research Site
Ruddington, United Kingdom, NG11 6JS