A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects Being Overweight or With Obesity.
Status: | Completed |
---|---|
Conditions: | Obesity Weight Loss, Obesity Weight Loss |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 9/7/2018 |
Start Date: | October 10, 2016 |
End Date: | September 30, 2017 |
This Trial is Conducted in the United State of America. The Aim of This Trial is to Investigate Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects Being Overweight or With Obesity
Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of
NNC9204-1177 in Subjects being Overweight or with Obesity
NNC9204-1177 in Subjects being Overweight or with Obesity
Inclusion Criteria:
- Male, aged 18-55 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) between 25.0 and 34.9 kg/m^2 (both inclusive) at screening
Exclusion Criteria:
- Any disorder which in the investigator's opinion might jeopardise subject's safety,
evaluation of results, or compliance with the protocol
- Subjects, aged at least 40 years, with an estimated 10-year atherosclerotic
cardiovascular disease (ASCVD) (as described in the American College of Cardiology and
the American Heart Association Prevention Guideline) risk above or equal to 5%
- Male subjects who are not sexually abstinent or surgically sterilised (vasectomy) and
are sexually active with female partner(s) who are not using a highly effective method
of contraception (such as condom with spermicide) combined with a highly effective
method of contraception for their non-pregnant female partner(s) (Pearl Index below
1%, such as implants, injectables, oral contraceptives, intrauterine devices,
diaphragm or cervical cap+spermicide), and/or intend to donate sperm in the period
from screening until 3 months following administration of the investigational medical
product
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