Bioequivalence Study of INS062 and Pharmacokinetics and Pharmacokinetics Study of Single Injection of HR20014 in Healthy Subjects

What Was Tested

This registered phase 1 trial tested Insulin Aspart.

This study was divided into two parts.

It had four arms (groups): INS062 (experimental), NovoRapid ® (active comparator), HR20014 (experimental) and BIAsp 30 (active comparator).

The registry classes the interventions as drug.

Who Took Part

60 planned participants were the target.

It was open to people of any sex aged from 18 years up to 45 years.

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

Examples of who could join: Male subjects aged 18 \~ 45 (including the boundary. value)(Part I). Subjects aged 18 \~ 45 (including the boundary value), male or female(Part II). Subjects who are considered to be generally healthy, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator. Body Mass Index (BMI) between 18.0-26.0 kg/m2 (both inclusive).

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: A history of recurrent or severe drug food allergy, or known or suspected allergy to any component of the study drug; have a history of hypertension; severe systemic infectious diseases within 1 month before screening.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.

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

Blinding on both sides kept the participants and researchers unaware of who received Insulin Aspart.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2023-01-05 with completion listed for 2023-07-01.

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 （Part I）. Maximum concentration（Part I）. Area under the Glucose Infusion Rate (GIR) - time curve （Part I）.

It also tracked 7 secondary outcomes, for example Time to maximum concentration （Part I）, Terminal half-life （Part I）, Time to maximum GIR （Part I）, Incidence of anti-drug antibody (ADA)（Part I）, Incidence and severity of adverse events (AEs)（Part I） and Incidence of anti-drug antibody (ADA)（Part II）.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 60 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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