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Type 2 Diabetes MellitusPhase 1NCT06137469

Assessment of Gastric Emptying by SHR20004 in Healthy Subjects

A Phase 1 study testing Acetaminophen/SHR20004 in people with Type 2 Diabetes Mellitus, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to investigate the impact of SHR20004 on the pharmacokinetic (PK) characteristics of acetaminophen in healthy subjects. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Acetaminophen/SHR20004
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
1 siteChina
Study dates
26 Dec 2023to 16 Mar 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
  • Healthy males or females aged 18-55 years (inclusive, as of signing the informed consent form).
  • Body mass index (BMI) between 19 and 28 kg/m2 (inclusive), with a weight ≥ 50 kg.
  • Have not used GLP-1 or its analogs, DPP Ⅳ inhibitors or its analogs, or other glucose-lowering drugs.

Who cannot join

  • -
  • 1. Subjects with any of the following conditions or medical history:
  • Any clinical disease that the investigator determines may affect the safety or results of the study.
  • Diagnosed with diabetes according to the WHO guidelines for the diagnosis and management of diabetes.
  • A history of thyroid cancer or family history of thyroid cancer, a history of pancreatitis, or symptomatic gallstones.
  • History of severe systemic infection within 1 month of screening.
Show all 24Show fewer
  • 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.
  • Subjects with clinically significant abnormal thyroid function at screening.
  • 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.
  • 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:
  • A history of recurrent or severe drug-food allergies, or known or suspected allergy to any component of the investigational drug.
  • Participation in any drug clinical trial within the past 3 months (defined as receiving trial drug treatment).
  • 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.
  • 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.
  • 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.
  • Participation in intense exercise within the past 48 hours, such as weightlifting, sprinting, long-distance running, cycling, swimming, or soccer.
  • Known or suspected history of drug abuse or a positive urine drug screening test during screening.
  • 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.
  • Positive serology for hepatitis B surface antigen (HBsAg), hepatitis C (HCV), syphilis, or human immunodeficiency virus (HIV) antibodies.
  • 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.
  • 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.
  • Subjects who, in the opinion of the investigator, have any other condition that could interfere with the evaluation of the trial results.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

Other trials in China

About this study

Official title: 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

The purpose of this study is to investigate the impact of SHR20004 on the pharmacokinetic (PK) characteristics of acetaminophen in healthy subjects.

Being tested
Acetaminophen/SHR20004, Acetaminophen/Placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acetaminophen/SHR20004Drug

    SHR20004 was administered by titration, with all subjects starting on Day 4 with an initial dose of 0.03 mg/d of SHR20004 or placebo, with the dose being increased by 0.03 mg/d per week. The dose was increased to 0.15 mg/d and then maintained for 5 days.

  • Acetaminophen/PlaceboDrug

    Placebo was administered by titration, with all subjects starting on Day 4 with an initial dose of 0.03 mg/d of SHR20004 or placebo, with the dose being increased by 0.03 mg/d per week. The dose was increased to 0.15 mg/d and then maintained for 5 days.

Study groups in NCT06137469
Study groupRoleWhat they receive
Acetaminophen+SHR20004ExperimentalNot described
Receives: Drug: Acetaminophen/SHR20004
Acetaminophen+PlaceboExperimentalNot described
Receives: Drug: Acetaminophen/Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (14)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  8. Incidence and severity of AE/SAE/AESI.

    Measured: Screening period up to Day 50

  9. Electrocardiographic parameters Fridericia-corrected QT interval (QTcF)

    Mean QTcF as measured based on triplicate electrocardiograms extracted from continuous 12-lead Holter monitor recordings.

    Measured: Day 1 and Day 10 and Day 30 and Day 36

  10. Delta QTcF

    Mean change from baseline in QTcF as measured based on triplicate electrocardiograms extracted from continuous 12-lead Holter monitor recordings after study drug intake.

    Measured: Day 1 and Day 10 and Day 30 and Day 36

  11. Double-delta QTcF (ΔΔQTcF)

    Mean change from baseline and placebo in QTcF as measured based on triplicate electrocardiograms extracted from continuous 12-lead Holter monitor recordings after study drug intake.

    Measured: Day 1 and Day 10 and Day 30 and Day 36

  12. Concentration-delta QTcF Correlation

    Correlation between SHR20004 plasma concentration and delta QTcF based on appropriate regression model.

    Measured: Day 1 and Day 10 and Day 30 and Day 36

  13. Concentration-double-delta QTcF Correlation

    Correlation between SHR20004 plasma concentration and double-delta QTcF based on appropriate regression model.

    Measured: Day 1 and Day 10 and Day 30 and Day 36

  14. Immunogenicity indicators: anti-Noiiglutide antibodies

    Measured: Start of treatment up to Day 50

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start26 Dec 2023
  3. Primary completion16 Mar 2024
  4. Study completion16 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Single group
Model description
This study is a single-center, randomized, double-blind, placebo-controlled, crossover study. Healthy subjects were randomly assigned to receive SHR20004 or placebo treatment. In the group receiving SHR20004, the pharmacokinetic changes of acetaminophen were compared before and after treatment with SHR20004.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06137469
Sponsor's protocol ID
SHR20004-106
Status last verified
Feb 2024
First submitted
14 Nov 2023
Last updated
2 Dec 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Acetaminophen/SHR20004 in people with Type 2 Diabetes Mellitus, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06137469.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.

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