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The Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of HEC88473 in Healthy Subjects
A Phase 1, Double Blind, Placebo Controlled, Single and Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of HEC88473 in Healthy Subjects
Lead sponsor
Asset
HEC88473
Subcutaneous · GLP-1 / FGF21 dual
Listed sites
1
Recruiting sites
—
Enrollment
64
actual
Study population
Healthy volunteers
Key I/E criterion
•BMI 18-40
Primary endpoints
•Frequency and severity of Adverse Events (AEs)•Cmax•AUC
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Males or females, of any race, between 18 and 60 years of age, inclusive, at screening.
2. Body weight ≥ 50 kg, and body mass index between 18.0 and 40.0 kg/m2, inclusive, at screening.
3. In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations at screening as assessed by the investigator (or designee).
4. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
Exclusion criteria
1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
3. History of alcoholism or drug/chemical abuse within 2 years prior to the first dosing.
4. Alcohol consumption of > 21 units per week for males and > 14 units per week for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine.
5. Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at screening and/or check-in.
6. Immunization with a live attenuated vaccine or coronavirus vaccination within 1 month prior to the first dosing or planned vaccination during the course of the study.
7. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives (if known), whichever is longer, prior to the first dosing.
8. Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to first dosing, unless deemed acceptable by the investigator (or designee).
Endpoints (6)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Glycemic / diabetes
1 endpointOGTT
Time frame:Predose and postdose 2, 4 hours
descriptive
Safety / tolerability / PK
5 endpointsFrequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after a single dose of HEC88473
Time frame:Baseline to day 15
descriptive
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after multiple dose of HEC88473
Time frame:Baseline to day 43
descriptive
Cmax
Time frame:Predose and postdose 4, 8, 10, 12, 14, 24, 48, 72, 96, 168, 216, and 336 hours
concentration, descriptive
AUC
Time frame:Predose and postdose 4, 8, 10, 12, 14, 24, 48, 72, 96, 168, 216, and 336 hours
concentration, descriptive
Assessment of the incidence of anti drug antibodies (ADA) developed against HEC88473 after dosing
Time frame:Baseline to day 43
event count, event
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.