← Trials/Trial dossier/NCT06137469

CompletedPhase 1

Assessment of Gastric Emptying by SHR20004 in Healthy Subjects

A Single-center, Randomized, Double-blind, Placebo-controlled, Crossover Study to Assess the Effect of Multiple Subcutaneous Injections of SHR20004 in Healthy Subjects on Gastric Emptying

Asset

Noiiglutide / HS-20004 / SHR20004

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

28

actual

Study population

Healthy volunteers

Key I/E criteria

BMI 19-28Healthy volunteers

Primary endpoint

Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g

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 IDNCT06137469
Org study IDSHR20004-106

Timeline

Milestones

Study first posted2023-11-18actual
Study start2023-12-26actual
Primary completion2024-03-16actual
Study completion2024-03-16actual
Last update posted2024-12-02actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

1. Voluntarily sign an informed consent form before participating in activities related to this trial and be able to understand the procedures and methods of the trial. Be willing to strictly follow the clinical trial protocol to complete the trial.

2. Healthy males or females aged 18-55 years (inclusive, as of signing the informed consent form).

3. Body mass index (BMI) between 19 and 28 kg/m2 (inclusive), with a weight ≥ 50 kg.

4. Have not used GLP-1 or its analogs, DPP Ⅳ inhibitors or its analogs, or other glucose-lowering drugs.

Exclusion criteria

1. Subjects with any of the following conditions or medical history:

1. Any clinical disease that the investigator determines may affect the safety or results of the study.

2. Diagnosed with diabetes according to the WHO guidelines for the diagnosis and management of diabetes.

3. A history of thyroid cancer or family history of thyroid cancer, a history of pancreatitis, or symptomatic gallstones.

4. History of severe systemic infection within 1 month of screening.

5. History of severe cardiovascular disease, including decompensated heart failure (NYHA class III or IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, persistent and clinically significant arrhythmia, or history of coronary artery bypass surgery or percutaneous coronary intervention.

6. Subjects with clinically significant abnormal thyroid function at screening.

7. Prolonged QTcF interval on screening or baseline ECG (male > 450 ms, female > 470 ms), or other clinically significant abnormalities that may result in a significant safety risk for the subjects.

8. Subjects with severe mental disorders.

2. Use of prescription drugs (topical eye/ nasal drops and ointments are allowed) and over-the-counter drugs, food supplements, vitamins, and Chinese herbs within 2 weeks before the start of treatment (routine vitamins are allowed).

3. Any of the following:

1. A history of recurrent or severe drug-food allergies, or known or suspected allergy to any component of the investigational drug.

2. Participation in any drug clinical trial within the past 3 months (defined as receiving trial drug treatment).

3. Consumption of more than 14 standard units of alcohol per week (1 standard unit contains 14 g of alcohol, such as 360 mL of beer or 45 mL of alcohol with a 40% alcohol content or 150 mL of wine) within the past 1 year, or a positive breath alcohol test.

4. A history of smoking (≥5 cigarettes per day for the past 1 year) or a history of smoking in the past 1 year; subjects who cannot or are unwilling to abstain from smoking during the study period, or subjects who cannot use nicotine gum or transdermal nicotine patches.

5. Long-term or consumption within the past 48 hours of coffee, tea, chocolate, or soft drinks that contain methylxanthines (theophylline, caffeine, or theobromine), such as Coca-Cola.

6. Participation in intense exercise within the past 48 hours, such as weightlifting, sprinting, long-distance running, cycling, swimming, or soccer.

7. Known or suspected history of drug abuse or a positive urine drug screening test during screening.

8. Blood donation of ≥400 mL within the past 3 months or subjects with a bleeding event of ≥400 mL within the past 3 months, such as major surgery or trauma.

9. Positive serology for hepatitis B surface antigen (HBsAg), hepatitis C (HCV), syphilis, or human immunodeficiency virus (HIV) antibodies.

10. Subjects who are assessed by the investigator as having poor compliance or arm vein condition that cannot allow blood to be drawn, or subjects with a history of fainting or dizziness with needles.

11. Pregnant and lactating women, or male and female subjects who are of childbearing age and do not wish to use effective contraception for 2 weeks after the last dose of study medication.

12. Subjects who, in the opinion of the investigator, have any other condition that could interfere with the evaluation of the trial results.

Endpoints (15)

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.

Safety / tolerability / PK

15 endpoints
Primary/protocol endpoint

Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.:(AUC0-300min)

Time frame:Based on pre-dose to 300 min post-dose sampling times on Day 1 and Day 31

ratio, event

Secondary/protocol endpoint

Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.: (AUC0-60min)

Time frame:Based on pre-dose to 300 min post-dose sampling times on Day 1 and Day 31

ratio, event

Secondary/protocol endpoint

Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.: (AUC0-60min/AUC0-300min)

Time frame:Based on pre-dose to 300 min post-dose sampling times on Day 1 and Day 31

ratio, event

Secondary/protocol endpoint

Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.: (Cmax)

Time frame:Based on pre-dose to 300 min post-dose sampling times on Day 1 and Day 31

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.: (Tmax)

Time frame:Based on pre-dose to 300 min post-dose sampling times on Day 1 and Day 31

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.: (t1/2)

Time frame:Based on pre-dose to min post-dose sampling times on Day 1 and Day 31

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.: (CL/F)

Time frame:Based on pre-dose to 300 min post-dose sampling times on Day 1 and Day 31

ratio, event

Secondary/protocol endpoint

Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.: (Vz/F)

Time frame:Based on pre-dose to 300 min post-dose sampling times on Day 1 and Day 31

ratio, event

Secondary/protocol endpoint

Incidence and severity of AE/SAE/AESI.

Time frame:Screening period up to Day 50

descriptive

Secondary/protocol endpoint

Electrocardiographic parameters Fridericia-corrected QT interval (QTcF)

Time frame:Day 1 and Day 10 and Day 30 and Day 36

descriptive

Secondary/protocol endpoint

Delta QTcF

Time frame:Day 1 and Day 10 and Day 30 and Day 36

descriptive

Secondary/protocol endpoint

Double-delta QTcF (ΔΔQTcF)

Time frame:Day 1 and Day 10 and Day 30 and Day 36

descriptive

Secondary/protocol endpoint

Concentration-delta QTcF Correlation

Time frame:Day 1 and Day 10 and Day 30 and Day 36

concentration, descriptive

Secondary/protocol endpoint

Concentration-double-delta QTcF Correlation

Time frame:Day 1 and Day 10 and Day 30 and Day 36

concentration, descriptive

Secondary/protocol endpoint

Immunogenicity indicators: anti-Noiiglutide antibodies

Time frame:Start of treatment up to Day 50

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.