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

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 - ZGN-1061 SAD, MAD, safety, PK and PD study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42985

Enrollment

Registered

2016-10-14

Start date

2016-06-30

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Obesitas Obesity

Interventions

Segment 1: The study will consist of 1 period during which the volunteer will receive ZGN-1061 or placebo once. ZGN 1061 and placebo will be given as an injection given into the fat layer beneath th

Obesity

ZGN-1061

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: healthy male or female subjects 18-55 years, inclusive BMI: SAD segment: 23.0 to

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and tolerability of single and multiple ascending doses of ZGN-1061 in healthy normal weight, overweight and obese volunteers	—

Secondary

Measure	Time frame
To evaluate the pharmacokinetic (PK) profiles of single and multiple ascending doses of ZGN-1061 in healthy normal weight, overweight and obese volunteers	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)