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drugset / Trial / NCT07102251

A Study to Evaluate the Safety, Tolerability, PK/PD of HEC-007 Injection in Healthy and Overweight/Obese Subjects

NCT07102251 ↗

Phase 1 Recruiting 126 enrolled Sunshine Lake Pharma Co., Ltd.
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2025-09-21
Primary completion
2026-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject HEC-007 Unknown — —

Indications

No indication recorded.