To Compare the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability Between SHR-3167 Injection and Glargine Insulin in Healthy Subjects

What Was Tested

This registered phase 1 trial tested Insulin Glargine.

It had 1 arm (groups): insulin glargine followed by SHR-3167 injection (experimental).

Participants will receive a single injection of glargine in the Glargine period and then washout. After that, participants will receive a single injection of SHR-3167 in the SHR-3167 period.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 24 actual participants took part.

It was open to men only aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Voluntarily participate in the trial and sign the informed consent form; as judged by the researcher, the subjects are willing and able to adhere to all trial requirements and restrictions. Healthy males, aged 18-55 years (inclusive). Body mass index (BMI) within the range of 19.0-24.0 kg/m2 (inclusive); weight ≥50 kg. Capable of good communication with the researcher and able to comply with the trial requirements to complete the study.

The full record lists 8 inclusion and 21 exclusion criteria; among the exclusions: history of diabetes or a first-degree relative with a history of diabetes; history of hypokalemia, orthostatic hypotension, syncope, blackout, or severe hypoglycemic episodes; history of severe hypersensitivity reactions or known allergy to the investigational drug, its excipients, insulin, or insulin analogs.

How the Study Was Run

The set-up was sequential and open-label.

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2024-02-26 with completion listed for 2024-07-12.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Glucose infusion rate (GIR) - area under the curve (AUC) (time frame: Glargine period: 0-24hour ; SHR-3167 period: 0-226hour).

It also tracked 10 secondary outcomes, for example area under the curve (AUC0-t, AUC0-∞), maximum concentration (Cmax), time to reach maximum concentration (Tmax), half-life (t1/2), apparent clearance (CL/F) and apparent volume of distribution (Vz/F).

What This Means in Plain Language

Put simply, this is a phase 1 trial of Insulin Glargine in 24 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page, all human trials.