Diabetes in AdultsPhase 1NCT05147259
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HR011408 at Two Formulations in Healthy Subject
A Phase 1 study testing HR011408 injection in people with Diabetes in Adults, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The objective of the study is to assess the safety, tolerability and pharmacokinetics of HR011408 at two formulations in healthy subject. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes in Adults
- What is being tested?
- HR011408 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 26 Nov 2021to 22 Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Randomized, Double-Blind, Single Ascending Dose, Crossover Designed Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HR011408 at Two Formulations in Healthy Subject
The objective of the study is to assess the safety, tolerability and pharmacokinetics of HR011408 at two formulations in healthy subject.
- Conditions
- Diabetes in Adults
- Being tested
- HR011408 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR011408 injectionDrug
Drug: HR011408 injection (formulation A), administered subcutaneously. Drug: HR011408 injection (formulation B), administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Cohort one: Low dose | Experimental | Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively Receives: Drug: HR011408 injection |
| Cohort two: Medium dose | Experimental | Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively Receives: Drug: HR011408 injection |
| Cohort three: high dose | Experimental | Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively Receives: Drug: HR011408 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs)
The incidence of adverse events will be collected and the safety of HR011408 will be assessed
Measured: from Day1 to Day15
Area under the concentration-time curve (AUC)
Area under the concentration-time curve (AUC)
Measured: from 0 to 10 hours after dose administration
Maximum observed concentration (Cmax)
Maximum observed concentration (Cmax)
Measured: from 0 to 10 hours after dose administration
Time to maximum observed concentration (Tmax)
Time to maximum observed concentration (Tmax)
Measured: from 0 to 10 hours after dose administration
Elimination half-life (t1/2)
Elimination half-life (t1/2)
Measured: from 0 to 10 hours after dose administration
Time to 50% maximum observed concentration (time to 50% Cmax)
Time to 50% maximum observed concentration (time to 50% Cmax)
Measured: from 0 to 10 hours after dose administration
Onset of appearance
First time point after dose administration when concentration reaches lower limit of quantification (LLOQ)
Measured: from 0 to 10 hours after dose administration
Secondary outcomes (1)
Assessment of development of Anti-drug Antibodies (ADAs)
Incidence of Anti-drug Antibodies (ADAs) will be assessed
Measured: from Day1 to Day15 after dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start26 Nov 2021
- Primary completion22 Jan 2022
- Study completion22 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes in AdultsStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assigned to HR011408(formulation A) or HR011408(formulation B)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05147259
- Sponsor's protocol ID
- HR011408-101
- Status last verified
- May 2026
- First submitted
- 24 Nov 2021
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Double-Blind, Single Ascending Dose, Crossover Designed Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HR011408 at Two Formulations in Healthy Subject
- ClinicalTrials.gov ID
- NCT05147259
- Acronym / sponsor ID
- HR011408-101
- Conditions
- Diabetes in Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Nov 2021 (actual)
- Primary completion
- 22 Jan 2022 (actual)
- Study completion
- 22 Jan 2022 (actual)
- First posted
- 7 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to assess the safety, tolerability and pharmacokinetics of HR011408 at two formulations in healthy subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Crossover Assigned to HR011408(formulation A) or HR011408(formulation B)
| Arm | Type | Receives |
|---|---|---|
| Cohort one: Low dose | Experimental | Drug: HR011408 injectionSubjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively |
| Cohort two: Medium dose | Experimental | Drug: HR011408 injectionSubjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively |
| Cohort three: high dose | Experimental | Drug: HR011408 injectionSubjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HR011408 injectionDrug: HR011408 injection (formulation A), administered subcutaneously. Drug: HR011408 injection (formulation B), administered subcutaneously. | Drug | Cohort one: Low dose, Cohort three: high dose, Cohort two: Medium dose |
Primary outcome
Incidence and severity of adverse events (AEs)
Time frame: from Day1 to Day15
The incidence of adverse events will be collected and the safety of HR011408 will be assessed
Area under the concentration-time curve (AUC)
Time frame: from 0 to 10 hours after dose administration
Area under the concentration-time curve (AUC)
Maximum observed concentration (Cmax)
Time frame: from 0 to 10 hours after dose administration
Maximum observed concentration (Cmax)
Time to maximum observed concentration (Tmax)
Time frame: from 0 to 10 hours after dose administration
Time to maximum observed concentration (Tmax)
Elimination half-life (t1/2)
Time frame: from 0 to 10 hours after dose administration
Elimination half-life (t1/2)
Time to 50% maximum observed concentration (time to 50% Cmax)
Time frame: from 0 to 10 hours after dose administration
Time to 50% maximum observed concentration (time to 50% Cmax)
Onset of appearance
Time frame: from 0 to 10 hours after dose administration
First time point after dose administration when concentration reaches lower limit of quantification (LLOQ)
1 secondary outcome
Assessment of development of Anti-drug Antibodies (ADAs)
Time frame: from Day1 to Day15 after dose administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HR011408 injection in people with Diabetes in Adults, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) (time frame: from Day1 to Day15). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.