Comparing bioavailability and safety of different SHR-3167 injection formulations

A Randomized, Parallel, Open-label Clinical Study on the Bioavailability and Safety of Different Specifications of SHR-3167 Injection in Healthy Subjects

This trial will test how different formulations of the SHR-3167 injection are absorbed and whether they are safe in healthy adults aged 18–55.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT07489482 on ClinicalTrials.gov

What this trial studies

This is a randomized, parallel, open-label Phase 1 trial comparing the relative bioavailability and safety of different specifications of SHR-3167 injection in healthy adult volunteers. Participants are assigned to parallel groups to receive the different SHR-3167 formulations and undergo timed blood sampling for pharmacokinetic analysis and regular safety monitoring. Safety assessments include physical exams, vital signs, 12-lead ECGs, chest X-rays, and laboratory tests, with adverse events recorded throughout the study. Results will inform formulation and dosing decisions for later-stage clinical development.

Who should consider this trial

Good fit: Ideal participants are healthy adults 18–55 years old with BMI 19.0–26.0 kg/m² (men ≥50 kg, women ≥45 kg) who meet screening exams and agree to required contraception and study procedures.

Not a fit: People with active diabetes, pregnant or breastfeeding individuals, those outside the age or BMI ranges, or anyone on interfering medications are unlikely to receive direct benefit from this Phase 1 trial.

Why it matters

Potential benefit: If successful, the trial could identify a SHR-3167 formulation with predictable absorption and acceptable safety that enables further development of a diabetes treatment.

How similar studies have performed: Phase 1 bioavailability and safety trials are a routine first step for new injections and commonly succeed in identifying suitable formulations, although no public data on SHR-3167 are available.

Eligibility criteria

Inclusion Criteria:

1. Male or female: 18 years old to 55 years old (on the day of signing the informed consent form).
2. For healthy subjects, the body mass index (BMI) should be between 19.0 kg/m² and 26.0 kg/m², and the weight of men should be ≥ 50 kg and that of women ≥ 45 kg.
3. Those who show no abnormalities through physical examination, vital signs, 12-lead electrocardiogram, frontal and lateral chest radiographs and laboratory tests, or have minor abnormalities but are judged by the researcher to have no clinical significance.
4. Female subjects of childbearing potential or male subjects whose partners are of childbearing potential must have no plans for conception or sperm/egg donation from the time of signing the informed consent form until 4 months after the last dose, and must voluntarily refrain from unprotected sexual activity within 14 days before the screening period and use effective contraceptive measures (including partners) during the study period; female subjects of childbearing potential must have no unprotected sexual activity in the past 14 days, have a negative pregnancy test during the screening period, and not be in the lactation period.
5. During the screening process, the fasting blood glucose should be between 3.9 mmol/L and 6.1 mmol/L, and the glycated hemoglobin (HbA1c) should be no more than 6.0%.
6. Understand the research procedures and methods, voluntarily participate and have the ability to comply with the requirements of the trial protocol to complete this trial, and sign the informed consent form in person.

Exclusion Criteria:

1. Those with a history of frequent allergies or allergic diseases, or those who, as judged by the researcher, may be allergic to the study drug or its components or foods, etc.
2. Those who have previously suffered from respiratory system, circulatory system, digestive system, urinary system, mental, nervous system, blood system, endocrine system, immune system or malignant tumor diseases, and who, based on the investigator's judgment, are not suitable to participate in this trial.
3. Exclude those who had severe infections, severe injuries or surgeries within the previous 12 weeks, or those who plan to undergo surgery during the trial.
4. Exclude those who have participated in any clinical trials of other drugs or medical devices within the previous 3 months prior to screening, or those who are still within 5 half-lives of the trial drug at the time of screening (whichever is longer).
5. Exclude those who have used any medication (including prescription drugs, over-the-counter drugs, herbal medicines, patent medicines, health supplements, etc.) within the previous 2 weeks up to the time of randomization.
6. Positive results were obtained for hepatitis B surface antigen (HBsAg), HIV antibody, Treponema pallidum specific antibody, or hepatitis C virus antibody tests; or the investigator judged that the subject was in the latent or active stage of the aforementioned infections.
7. Exclude those who have a history of blood donation within the past 12 weeks, or have suffered from severe blood loss (blood loss ≥ 400 mL), or have received blood transfusion within the past 12 weeks.
8. Those who received live (attenuated) vaccines within the previous 1 month or are scheduled to receive such vaccines during the trial process.
9. Those who have a history of drug use or substance abuse; or those who tested positive for drugs in the baseline visit.
10. Those who have difficulty in venous blood collection or whose physical condition does not allow for blood collection; or those who are expected not to comply well with the protocol or complete the entire trial follow-up.
11. Persons with incomplete civil capacity and without a valid guardian.
12. The researchers determined that any physical or psychological condition or illness that might increase the risk of the trial, affect the subjects' compliance with the protocol, or prevent the subjects from completing the trial.

Where this trial is running

Changsha, Hunan

• Xiangya Hospital, Central South University — Changsha, Hunan, China (Recruiting)

Study contacts

• Study coordinator: Yanli Dong

Conditions Diabetes Mellitus