CompletedPhase 1

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HR011408 at Two Formulations in Healthy Subject

China62 participantsStarted 2021-11-26

Plain-language summary

The objective of the study is to assess the safety, tolerability and pharmacokinetics of HR011408 at two formulations in healthy subject.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female aged 18-55 years (both inclusive) at the time of signing informed consent.
. Body mass index 18.0-26.0kg/m2 (both inclusive).
. Body weight ≥ 50.0 kg (male),≥ 45.0 kg (female).
. Fasting serum/plasma glucose \< 6.1 mmol/L.

Exclusion criteria

. Known or suspected of being allergic to any ingredient in the study drug.
. Participated in any drug or medical device-related clinical trial within 3 months before screening.
. Subjects addicted to smoking, or non-smoker who smoked within 48 hours before administration.
. Donated blood within 1 month before screening; or donated blood ≥ 400 mL or had blood loss ≥ 400 mL during trauma or major surgery within 3 months before screening.
. Subjects with incompetence or language impairment, who cannot fully understand or participate in the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence and severity of adverse events (AEs)

Timeframe: from Day1 to Day15

Area under the concentration-time curve (AUC)

Timeframe: from 0 to 10 hours after dose administration

Maximum observed concentration (Cmax)

Timeframe: from 0 to 10 hours after dose administration

Time to maximum observed concentration (Tmax)

Timeframe: from 0 to 10 hours after dose administration

Elimination half-life (t1/2)

Timeframe: from 0 to 10 hours after dose administration

Time to 50% maximum observed concentration (time to 50% Cmax)

Timeframe: from 0 to 10 hours after dose administration

Onset of appearance

Timeframe: from 0 to 10 hours after dose administration

Trial details

NCT IDNCT05147259

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-01-22

View on ClinicalTrials.gov More Diabetes in Adults trials

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female aged 18-55 years (both inclusive) at the time of signing informed consent.
. Body mass index 18.0-26.0kg/m2 (both inclusive).
. Body weight ≥ 50.0 kg (male),≥ 45.0 kg (female).
. Fasting serum/plasma glucose \< 6.1 mmol/L.

Exclusion criteria

. Known or suspected of being allergic to any ingredient in the study drug.
. Participated in any drug or medical device-related clinical trial within 3 months before screening.
. Subjects addicted to smoking, or non-smoker who smoked within 48 hours before administration.
. Donated blood within 1 month before screening; or donated blood ≥ 400 mL or had blood loss ≥ 400 mL during trauma or major surgery within 3 months before screening.
. Subjects with incompetence or language impairment, who cannot fully understand or participate in the study.

What they're measuring

Incidence and severity of adverse events (AEs)

Timeframe: from Day1 to Day15

Area under the concentration-time curve (AUC)

Timeframe: from 0 to 10 hours after dose administration

Maximum observed concentration (Cmax)

Timeframe: from 0 to 10 hours after dose administration

Time to maximum observed concentration (Tmax)

Timeframe: from 0 to 10 hours after dose administration

Elimination half-life (t1/2)

Timeframe: from 0 to 10 hours after dose administration

Time to 50% maximum observed concentration (time to 50% Cmax)

Timeframe: from 0 to 10 hours after dose administration

Onset of appearance

Timeframe: from 0 to 10 hours after dose administration