NCT07102251

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	HEC-007 injection	Single dose escalation of HEC-007 injection in healthy subjects
DRUG	Placebo	Single dose of placebo in healthy adults
DRUG	HEC-007 injection	Multiple dose escalation of HEC-007 injection in Overweight or Obese Subjects
DRUG	Placebo	Multiple dose of placebo in Overweight or Obese Subjects

Timeline

• Start date: 2025-08-31
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-08-03
• Last updated: 2025-08-29