A Trial to Evaluate the Pharmacokinetics and Pharmacodynamics of THDB0206 Injection in Healthy Chinese Subjects

What Was Tested

This registered phase 1 trial tested Insulin Lispro.

This trial will enroll 39 subjects to receive the investigational medicinal products.

It had three arms (groups): THDB0206 injection (experimental), Humalog® (active comparator) and BC222insulin lispro injection (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 39 actual participants took part.

It was open to people of any sex aged from 18 years up to 40 years.

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

Examples of who could join: Healthy local Chinese males or females, who complete medical history, physical examination and laboratory tests according to the judgment of the investigator. Aged ≥ 18 years and ≤ 40 years when signing the informed consent form. Body mass index (BMI) ≥ 18 kg/m2 and \< 25 kg/m2 at screening, male weight ≥ 50 kg, female weight ≥ 45 kg.

The full record lists 6 inclusion and 23 exclusion criteria; among the exclusions: known or suspected allergies to investigational medicinal products and related products, or a history of multiple and/or severe allergies to drugs or food; any cancer or history of cancer, including basal cell skin cancer or squamous cell skin cancer; the heart rate detected by 12-lead ecg at rest exceeds the range of 50-100 beats per minute (including 50 and 100 beats).

How the Study Was Run

It was run as a randomized, crossover and open-label study.

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

In the crossover set-up each of the participants took both Insulin Lispro and the comparison in turn, acting as their own control.

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

It started in 2021-06-17 with completion listed for 2022-06-06.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: AUCLisp(0-30 min) (time frame: From 0 to 30 minutes).

It also tracked 17 secondary outcomes, for example Cmax (Lisp), AUCLisp, tmax(Lisp), t1/2, CL/F and Vz/F.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro in 39 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 Lispro compound page, all human trials.