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

NCT07102251 | Recruiting Phase 1

• 1 other identifier: HEC-007-OB-101
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (12)

• Adverse events (AEs)

  Screening period up to day 43/day 113

• The maximum plasma concentration (Cmax)

  Post-dose at day 1 to day 43/day 113

• Time to maximum plasma concentration (Tmax)

  Post-dose at day 1 to day 43/day 113

• Terminal half-life (t1/2)

  Post-dose at day 1 to day 43/day 113

• Apparent clearance (CL/F)

  Post-dose at day 1 to day 43/day 113

• Apparent volume of distribution (Vz/F)

  Post-dose at day 1 to day 43/day 113

• Area Under the PlasmaConcentration-TimeCurve (AUC) of HEC-007

  Post-dose at day 1 to day 43/day 113

• Changes from baseline in Body Weight

  Baseline period up to day 43/day 113

• Changes from baseline in waist circumference

  Baseline period up to day 43/day 113

• Changes from baseline in Fasting Plasma Glucose

  Baseline period up to day 43/day 113

• Changes from baseline in Fasting Insulin

  Baseline period up to day 43/day 113

• Changes from baseline in fasting blood lipids

  Baseline period up to day 43/day 113

Study Arms (4)

SAD Stage: HEC-007 Injection

EXPERIMENTAL

Administered once

Drug: HEC-007 injection

SAD Stage: Placebo

PLACEBO COMPARATOR

Administered once

Drug: Placebo

MAD Stage: HEC-007 injection

EXPERIMENTAL

Administered for multiple dose

Drug: HEC-007 injection

MAD Stage: Placebo

PLACEBO COMPARATOR

Administered for multiple dose

Drug: Placebo

Interventions

HEC-007 injection DRUG

Single dose escalation of HEC-007 injection in healthy subjects

SAD Stage: HEC-007 Injection

Placebo DRUG

Single dose of placebo in healthy adults

SAD Stage: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• SAD
• Subjects understand and comply with the study procedures, voluntarily participate, and sign the informed consent form.
• Healthy adult subjects (including borderline values) aged 18 to 45 years, regardless of sex.
• Male subjects weigh no less than 50 kg, and female subjects weigh no less than 45 kg. BMI =Body weight (kg)/height2 (m2), with a body mass index ranging from 19.0 to 35.0 kg/m2 (including boundary values).
• Normal results or abnormalities deemed clinically insignificant by the investigator in vital signs, physical examination, laboratory tests, electrocardiogram, chest CT, abdominal ultrasound (liver, gallbladder, spleen, pancreas, and both kidneys), and thyroid ultrasound.
• Female subjects of childbearing potential or male subjects must agree to use effective contraception from signing the informed consent until 6 months after the last administration of the investigational product to avoid pregnancy or impregnating a partner, with no plans for sperm or egg donation or pregnancy.
• Glycated hemoglobin (HbA1c) \<5.7% during the screening period. MAD
• \. Subjects understand and comply with the study procedures, voluntarily participate, and sign the informed consent form.
• \. Age between 18 to 65 years (inclusive), both male and female. 3. Obesity: BMI ≥28.0 kg/m2; or overweight: 24.0 \<BMI \<28.0 kg/m2, and with at least one of the following manifestations: prediabetes (as detailed in 14.4), hypertension, dyslipidemia, fatty liver, weight-bearing joint pain, obesity-related dyspnea, or obstructive sleep apnea syndrome.
• \. At screening, weight change of \< 5% over at least 12 weeks of diet and exercise control alone.
• \. Female subjects of childbearing potential or male subjects must agree to use effective contraceptionfrom signing the informed consent until 6 months after the last administration of the investigational product to avoid pregnancy or impregnating a partner, with no plans for sperm or egg donation or pregnancy.
• \. Glycated hemoglobin (HbA1c) \<6.5% during the screening period.

You may not qualify if:

• SAD
• Those diagnosed with type 1, type 2, or other types of diabetes before screening;
• History or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia syndrome type 2 (MEN2) during screening, or genetic predisposition to MTC;
• Acute, chronic, or suspected pancreatitis during screening, or prior pancreatectomy;
• Those diagnosed with any malignancy within 5 years before screening (except for basal cell carcinoma treated curatively and considered cured);
• Presence of clinically significant diseases (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immunological, psychiatric, or cardiovascular disorders) during screening;
• Diseases or conditions affecting gastric emptying or gastrointestinal nutrient absorption during screening;
• Major surgery within 3 months before screening or planned surgery during the study;
• History of hypersensitivity to the investigational product or any of its components, or allergic constitution (allergy to two or more drugs or foods).
• Use of medications (including prescription drugs, over-the-counter drugs, herbal medicines, health supplements, etc.) within 3 months prior to screening that, in the investigator's judgment, significantly affect weight or glucose metabolism;
• Individuals who have undergone bariatric surgery prior to screening;
• Those with a history of recurrent skin disorders (e.g., urticaria) or skin lesions at the administration site;
• Those who received chronic (lasting more than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intra-articular, or inhaled formulations) within 3 months prior to screening, or systemic glucocorticoid therapy within 1 month prior to screening;
• Female subjects with HbA1c \<110 g/L or male subjects with HbA1c \<120 g/L at screening, or any other known condition that interferes with HbA1c measurement;
• Those with suicidal behaviors or ideation within 6 months prior to screening;

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

The Second Affiliated Hospital of Anhui Medical University is a Grade A Tertiary General

Hefei, Anhui, 230601, China

RECRUITING

Central Study Contacts

Wei Hu, Doctor of Medicine

CONTACT

+8613856086475; ayefygcp@163.com

Yijun Du, Doctor of Medicine

CONTACT

+8613866700016; 2460679232@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, double-blind, placebo-controlled

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 3, 2025
• Study Start: September 21, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 27, 2026

Record last verified: 2025-08

Locations

CN (1)