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New diabetes drug candidate passes first safety check in healthy volunteers

NCT ID NCT05147259

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tested the safety and how the body processes a new drug called HR011408 in 62 healthy adults. Participants received two different versions of the drug to compare them. The goal was to check for side effects and measure drug levels in the blood, not to treat diabetes. This is a first step before testing in people with diabetes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HR011408 injection
What this could lead to
If successful, this could help develop a new treatment option for diabetes.
What could go wrong
This is an early Phase 1 trial in healthy people, not patients. It only tests safety and drug levels, not whether it works for diabetes. Many drugs fail in later stages.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

62 people

The number who actually took part.

Started

Nov 2021

Finished

Jan 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female aged 18-55 years (both inclusive) at the time of signing informed consent. 2. Body mass index 18.0-26.0kg/m2 (both inclusive). 3. Body weight ≥ 50.0 kg (male),≥ 45.0 kg (female). 4. Fasting serum/plasma glucose \< 6.1 mmol/L. Exclusion Criteria: 1. Known or suspected of being allergic to any ingredient in the study drug. 2. Participated in any drug or medical device-related clinical trial within 3 months before screening. 3. Subjects addicted to smoking, or non-smoker who smoked within 48 hours before administration. 4. 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. 5. Subjects with incompetence or language impairment, who cannot fully understand or participate in the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Shandong Provincial Qianfoshan Hospital

    Jinan, Shandong, 250014, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.