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A randomized, two-part, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ZGN-1061 in healthy normal weight, overweight and obese male and female volunteers

Completed
Conditions
Obesitas
Obesity
Registration Number
NL-OMON42985
Lead Sponsor
Zafgen, Inc.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
72
Inclusion Criteria

healthy male or female subjects
18-55 years, inclusive
BMI: SAD segment: 23.0 to <30.0 kg/m2, MAD segment: 30.0-40.0 kg/m2, inclusive

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study. Donation or loss of more than 100 mL of blood within 60 days prior to (the first)
drug administration. Donation or loss of more than 1.5 liters of blood (for male subjects) / more than 1.0 liters of blood (for female subjects) in the 10 months prior to (the first) drug administration in the current study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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