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CompletedPhase 1

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

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)CmaxAUC

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

NCT IDNCT04829123
Org study IDHEC88473-DM-102

Timeline

Milestones

Study first posted2021-04-02actual
Study start2021-05-14actual
Primary completion2022-03-02actual
Study completion2022-03-02actual
Last update posted2023-02-15actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age60 Years
SexAll
Healthy volunteersAccepted

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

Safety / tolerability / PK
5
Glycemic / diabetes
1

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

OGTT

Time frame:Predose and postdose 2, 4 hours

descriptive

Safety / tolerability / PK

5 endpoints
Primary/protocol endpoint

Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after a single dose of HEC88473

Time frame:Baseline to day 15

descriptive

Primary/protocol endpoint

Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after multiple dose of HEC88473

Time frame:Baseline to day 43

descriptive

Primary/protocol endpoint

Cmax

Time frame:Predose and postdose 4, 8, 10, 12, 14, 24, 48, 72, 96, 168, 216, and 336 hours

concentration, descriptive

Primary/protocol endpoint

AUC

Time frame:Predose and postdose 4, 8, 10, 12, 14, 24, 48, 72, 96, 168, 216, and 336 hours

concentration, descriptive

Secondary/protocol endpoint

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 identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.