A Study to Evaluate the Safety, Tolerability, PK/PD of HEC-007 Injection in Healthy and Overweigh… (NCT07102251) | Clinical Trial Compass
RecruitingPhase 1
A Study to Evaluate the Safety, Tolerability, PK/PD of HEC-007 Injection in Healthy and Overweight/Obese Subjects
China126 participantsStarted 2025-09-21
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕
What they're measuring
1
Adverse events (AEs)
Timeframe: Screening period up to day 43/day 113
2
The maximum plasma concentration (Cmax)
Timeframe: Post-dose at day 1 to day 43/day 113
3
Time to maximum plasma concentration (Tmax)
Timeframe: Post-dose at day 1 to day 43/day 113
4
Terminal half-life (t1/2)
Timeframe: Post-dose at day 1 to day 43/day 113
5
Apparent clearance (CL/F)
Timeframe: Post-dose at day 1 to day 43/day 113
6
Apparent volume of distribution (Vz/F)
Timeframe: Post-dose at day 1 to day 43/day 113
7
Area Under the PlasmaConcentration-TimeCurve (AUC) of HEC-007
. 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).