Healthy, Overweight and/or Obese Subjects Clinical Trial
Official title:
A Phase I, Randomized, Double-blind, Placebo-controlled Study to Determine the Safety, Tolerability, Pharmacokinetics, Food Effect and Pharmacodynamics of Single and Multiple Ascending Doses of P7435 in Healthy, Overweight and/or Obese Subjects
Clinical trial to study the safety tolerability, pharmacokinetics, food effect and pharmacodynamics of a new compound P7435 in in healthy, overweight and/or obese subjects
- A phase I, randomized, double-blind, placebo-controlled, dose escalating study of P7435
to determine the safety, tolerability, pharmacokinetics, food effect and
pharmacodynamics of single and multiple ascending doses of P7435.
- Subjects participating will be either healthy subjects or healthy overweight and/or
obese subjects. In this study, overweight/obese are defined as subjects having a BMI of
23 kg/m2 and above.
- The study will be conducted in 3 parts as follows: Part A will consist of the Single
Ascending Dose (SAD) study, Part B will consist of the Multiple Ascending Dose (MAD)
study and Part C will consist of the Food Effect study.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment