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

NCT07102251 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2026-04-27

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Sunshine Lake Pharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07102251 on ClinicalTrials.gov