A Study to Evaluate the Safety, Tolerability, PK/PD of HEC-007 Injection in Healthy and Overweight/Obese Subjects
A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HEC-007 Injection After Single-Dose Administration in Healthy Subjects and Multiple-Dose Administration in Overweight or Obese Subjects
Sunshine Lake Pharma Co., Ltd.
126 participants
Sep 21, 2025
INTERVENTIONAL
Conditions
Summary
This trial adopts a single-center, randomized, double-blind, placebo-controlled, dose-escalation design to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HEC-007 Injection after single-dose administration in healthy subjects and multiple-dose administration in overweight or obese subjects. The trial consists of two parts: Part A is a single ascending dose (SAD) study, planning to enroll 54 Chinese healthy subjects; Part B is a multiple ascending dose (MAD) study, planning to enroll 72 Chinese overweight or obese subjects.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Single dose escalation of HEC-007 injection in healthy subjects
Single dose of placebo in healthy adults
Multiple dose escalation of HEC-007 injection in Overweight or Obese Subjects
Multiple dose of placebo in Overweight or Obese Subjects
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07102251