AzTrials
AzTrials

Diabetes MellitusPhase 1NCT05336071

The Relative Bioavailability of INS068 Injection With Two Different Formulations in Healthy Subjects

A Phase 1 study testing INS068 injection in people with 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
Search all trials

Trial summary

The study is a single-centre, randomized, open, 2-period, 2-sequence crossover design clinical trial. It is planned to enroll 24 healthy male subjects. Subjects will receive INS068 injection on Day1 and Day8. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus
What is being tested?
INS068 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
12 May 2022to 2 Jun 2022
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
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • The subject can communicate well with the researcher, understand and comply with the requirements of this study, and understand and sign the informed consent.
  • Healthy subjects aged 18 ~ 55 (including the boundary value), healthy male.
  • Body mass index (BMI) within the range of 18 ~ 27 kg/m2 (including the boundary value) (BMI= weight (kg)/height 2 (m2)).
  • The physical examination, vital signs, laboratory examination, 12-lead electrocardiogram, abdominal B-ultrasound, and chest radiograph are normal or have no clinical significance.

Who cannot join

  • Presence of any abnormal and clinically significant laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function), Hemoglobin < 120g/L; White blood cells < 3.0 ×109/L; Platelets < 100 × 109/L;Serum creatinine > upper limit of normal (ULN);Transaminases (ALT, AST) > 2 times the upper limit of normal (2 × ULN);Alkaline phosphatase > 2 times the upper limit of normal (2 × ULN); Total bilirubin > 1.5 times the upper limit of normal (1.5× ULN) ;Fasting blood glucose >6.1mmol/L or <3.9mmol/L; HbA1c≥6.5%.
  • 2、12-lead electrocardiogram (ECG) showed abnormal and clinically significant. 3、Hepatitis B surface antigen positive, hepatitis C antibody positive. 4、Positive human immunodeficiency virus (HIV) serology and positive syphilis serology.
  • 5、Have a history of hypertension, or have a systolic blood pressure of 90-139 mmHg or a diastolic blood pressure outside the range of 60-89 mmHg at screening.
  • 6、Life-threatening disease (cancer other than basal cell skin cancer or squamous cell skin cancer) within 5 years.
  • 7、Severe infectious disease of vital organs within 1 month before screening. 8、History of serious cardiovascular disease, including decompensated heart failure (NYHA class III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, persistent and clinically significant rhythm Abnormal, or have undergone coronary artery bypass grafting or percutaneous coronary intervention, etc..
  • 9、Use of prescription drugs (topical eye/nasal drops and creams and occasional antipyretic and analgesic drugs such as acetaminophen within recommended doses are permitted) and over-the-counter drugs, dietary supplements, vitamins, and Chinese herbal medicine (regular vitamins are allowed).
Show all 18Show fewer
  • 10、A history of recurrent or severe drug food allergy, or known or suspected allergy to any component of the study drug.
  • 11、Those who have participated in any drug clinical trials within 3 months before screening, who participated in clinical trials are defined as: those who have used test drugs; The elder shall prevail).
  • 12、Alcoholism within 3 months prior to screening (average ≥14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); alcohol or alcohol consumption within 48 hours prior to dosing Gas test result is positive.
  • 13、Smokers (at least 5 cigarettes per day in the 1 year prior to screening) or non-smokers (less than 5 cigarettes per day in the 1 year prior to screening) who smoked (including nicotine replacement use) within 48 hours prior to dosing; during the trial Inability or unwillingness to smoke, nicotine gum, or transdermal nicotine patches.
  • 14、Drinking/eating coffee, tea, chocolate or soft drinks such as cola containing methylxanthines (theophylline, caffeine or theobromine) long-term or within 48 hours before administration.
  • 15、Do vigorous exercise, such as weightlifting, sprinting, long-distance running, cycling, swimming, football, etc., within 48 hours before administration.
  • 16、Known or suspected history of drug abuse or positive urine drug screening test within 5 years prior to screening.
  • 17、Donate blood within 1 month before screening; or donate blood ≥ 400 mL within 3 months before screening, or have trauma or major surgical operation with blood loss ≥ 400 mL.
  • 18、Mentally incapacitated or language-impaired subjects who cannot adequately understand or participate in the trial process.
  • 19、The investigator evaluates that the subject has poor compliance or the condition of the vein in the arm cannot draw blood, or has a history of fainting blood and needles.
  • 20、Males of childbearing potential but unwilling to use contraception during the trial and for four weeks after administration.
  • 21、At the discretion of the investigator, there are any other circumstances that interfere with the conduct of the trial or the assessment of the results.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Qian Foshan Hospital of Shandong Province

    Jinan, Shandong, 150036

Other trials in China

About this study

Official title: Study on Bioavailability Study of INS068 Injection by Subcutaneous Injection of New and Old Formulations in Healthy Subjects

The study is a single-centre, randomized, open, 2-period, 2-sequence crossover design clinical trial. It is planned to enroll 24 healthy male subjects. Subjects will receive INS068 injection on Day1 and Day8.

Being tested
INS068 injection
Medical subject headings
Diabetes Mellitus

What participants receive

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

  • INS068 injectionDrug

    Group A subjects were injected formulation T and formulation R of INS068 injection at Day1 and Day8.

  • INS068 injectionDrug

    Group B subjects were injected formulation R and formulation T of INS068 injection at Day1 and Day8.

Study groups in NCT05336071
Study groupRoleWhat they receive
Treatment group AExperimentalT - R(T: new formulation, R: old formulation)
Receives: Drug: INS068 injection
Treatment group BExperimentalR -T(T: new formulation, R: old formulation)
Receives: Drug: INS068 injection

What is being measured

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

  1. Maximum observed serum concentration (Cmax) of INS068 injection

    Measured: from Day1 to Day5 after the first cycle（each cycle is 5 days） and from Day8 to Day12 after the second cycle（each cycle is 5 days）

  2. Area under the plasma concentration versus time curve (AUC0-t) of INS068 injection

    Measured: from Day1 to Day5 after the first cycle（each cycle is 5 days） and from Day8 to Day12 after the second cycle（each cycle is 5 days）

  3. Area under the plasma concentration versus time curve (AUC0-inf ) of INS068 injection

    Measured: from Day1 to Day5 after the first cycle（each cycle is 5 days） and from Day8 to Day12 after the second cycle（each cycle is 5 days）

Secondary outcomes (5)

  1. Time to maximum observed serum concentration (Tmax) of INS068 injection

    Measured: from Day1 to Day5 after the first cycle（each cycle is 5 days） and from Day8 to Day12 after the second cycle（each cycle is 5 days）

  2. Time to elimination half-life (T1/2) of INS068 injection

    Measured: from Day1 to Day5 after the first cycle（each cycle is 5 days） and from Day8 to Day12 after the second cycle（each cycle is 5 days）

  3. The Clearance (CL/F) of INS068 injection

    Measured: from Day1 to Day5 after the first cycle（each cycle is 5 days） and from Day8 to Day12 after the second cycle（each cycle is 5 days）

  4. The apparent volume of distribution (Vz/F) of INS068 injection

    Measured: from Day1 to Day5 after the first cycle（each cycle is 5 days） and from Day8 to Day12 after the second cycle（each cycle is 5 days）

  5. Number of subjects with adverse events and the severity of adverse events

    Measured: from Day1 to Day16 after the first dose

Timeline

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

  1. First posted20 Apr 2022
  2. Study start12 May 2022
  3. Primary completion26 May 2022
  4. Study completion2 Jun 2022

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
Crossover
Model description
The study is a single-centre, randomized, open, 2-period, 2-sequence crossover design clinical trial.
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05336071
Sponsor's protocol ID
INS068-104
Status last verified
Jun 2023
First submitted
8 Apr 2022
Last updated
8 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Chen KG, Zhang YH, Ye PP, Gao XH, Song LL, Zhou HY, Li Q, Zhao FR, Shi JY, Yang XM, Shen K, Feng S, Zhao W. Pharmacokinetics and bioavailability of a new long-acting insulin analog in healthy Chinese volunteers: an open, randomized, single-dose, two-period and two-sequence cross-over study. Front Pharmacol. 2023 Dec 22;14:1294810. doi: 10.3389/fphar.2023.1294810. eCollection 2023.

    PubMed 38186641

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing INS068 injection in people with 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 18 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 8 Jun 2023. 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?

Maximum observed serum concentration (Cmax) of INS068 injection (time frame: from Day1 to Day5 after the first cycle（each cycle is 5 days） and from Day8 to Day12 after the second cycle（each cycle is 5 days）). The study lists 3 primary outcomes in all. 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 NCT05336071, which also lists 1 linked publication.

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 8 Jun 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in