DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT02746302

CompletedPhase 1

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HS-20004 in Healthy Chinese Volunteers

A Randomised, Double-blind, Single-centre, Placebo-controlled, Ascending Single s.c. Dose, Sequential Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HS-20004 in Healthy Chinese Subjects

Asset

Noiiglutide / HS-20004 / SHR20004

Oral · GLP-1 agonist

Listed sites

0

Recruiting sites

—

Enrollment

62

actual

Study population

Healthy volunteers

Key I/E criterion

•BMI 19-24

Primary endpoint

•Number of treatment emergent adverse events (TEAEs)

Identifiers

Registered as

NCT IDNCT02746302
Org study IDHS-20004-Ia

Timeline

Milestones

Study first posted2016-04-21estimated
Last update posted2016-04-21estimated
Study start2012-12 (month precision)
Primary completion2014-01actual (month precision)
Study completion2014-05actual (month precision)

Assets

Investigational agents

Noiiglutide / HS-20004 / SHR20004

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age45 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Body Mass Index (BMI) between 19 and 24 kg/m^2， inclusive， and a total body weight of at least 50 kg;

Exclusion criteria

•Clinically relevant abnormalities of physical examination, laboratory values, vital signs or ECG findings at the screening, as judged by the Investigator
•Have any other medical abnormality (such as cardiovascular, hepatic, renal, gastrointestinal, immunologic, hematological, hormonal, metabolic, neoplasmatic or mental disease), which in the opinion of the investigator, might affect the absorption, distribution, metabolism, and excretion of the study drug, or prevent the patient from following and completing the protocol
•Family history of diabetes, thyroid cancer, submandibular gland cancer, or history of pancreatitis, cholelithiasis, drug allergy, or serious unconscious hypoglycemia Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive
•History of drug or alcohol abuse within 6 months before randomization
•Use of GLP-1 analogues, DPP-IV enzyme inhibitors, as well as other hypoglycemic drugs within 3 months before randomization
•Use of any prescription drugs and Chinese herbal medicines within 4 weeks before randomization
•Use of non prescription drugs and food supplements (vitamins, etc.) within 2 weeks of randomization
•Participated any drug clinical trials within 3 months, or participated 3 or more than 3 drug clinical trials in the near year, or had blood donation/loss >400mL within 3 months
•Female subject of childbearing potential who does not use an acceptable method of birth control, is pregnant or planning a pregnancy, or breastfeeding, or male subject who does not use an acceptable method of birth control, within six months before randomization Subject who cannot refrain from smoking, eating and/or drinking containing xanthine/caffeine, or strenuous exercise, or others that affect drug absorption, distribution, metabolism and excretion within 2 days before the study drug administration Subject who is unsuitable for inclusion in the study in the opinion of the investigator

Endpoints (5)

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
3
Glycemic / diabetes
1
Other (unclassified)
1

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

24-hour profiles of plasma glucose and serum insulin

Time frame:From time 0 to 24 hours after single dose

concentration, descriptive

Safety / tolerability / PK

3 endpoints
Primary/protocol endpoint

Number of treatment emergent adverse events (TEAEs)

Time frame:From baseline up to 72 hours after single dose

event count, event

Secondary/protocol endpoint

Peak Plasma Concentration (Cmax) after dose

Time frame:From time 0 to 72 hours after single dose

concentration, descriptive

Secondary/protocol endpoint

Terminal elimination half-life (t½) for HS-20004

Time frame:From time 0 to 72 hours after single dose

concentration, descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Area under the plasma HS-20004 concentration versus time curve

Time frame:From time 0 to 72 hours after single dose

concentration, descriptive

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.