The Pharmacokinetics and Pharmacodynamics Between HR011408 and NovoRapid® in Healthy Subject

What Was Tested

This registered phase 1 trial tested Insulin Aspart.

It had six arms (groups): Cohort 1 (experimental), Cohort 2 (experimental), Cohort 3 (experimental), Cohort 4 (experimental) and Cohort 5 (experimental).

HR011408 injection + NovoRapid®.

NovoRapid® + HR011408 injection.

HR011408 injection + NovoRapid®.

The registry classes the interventions as drug.

Who Took Part

61 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: Informed consent obtained prior to any trial-related activities；. Male or female subjects aged 18-55 years (both inclusive) at the time of signing informed consent；. Body weight ≥50.0 kg for men and ≥45.0 kg for women, with body mass index (BMI) between 18.0 and 26.0 kg/m2 (both ends included)；.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: in the opinion of the investigator, are unsuitable for inclusion in the study.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

Because people in this Insulin Aspart study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Insulin Aspart and the comparison at some point, usually with a gap in between.

Neither the participants nor the staff measuring them knew who was on Insulin Aspart, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2023-03-20 with completion listed for 2023-10-26.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area under the concentration-time curve (AUC0-0.5h).

It also tracked 15 secondary outcomes, for example Area under the concentration-time curve (AUC0-15min), Area under the concentration-time curve (AUC0-1h), Area under the concentration-time curve (AUC0-1.5h), Area under the concentration-time curve (AUC0-2h), Area under the concentration-time curve (AUC0-10h) and Area under the concentration-time curve (AUC0-inf).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 61 people.

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

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