T2DM (Type 2 Diabetes Mellitus)Phase 1NCT05983289
Single Escalating Dose Study Of HSK7653 In Healthy Subjects
A Phase 1 study testing HSK7653 in people with T2DM (Type 2 Diabetes Mellitus), run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
To evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of single dose of HSK7653 tablets in healthy adult subjects, and to identify the metabolites of HSK7653 in healthy adult subjects Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- T2DM (Type 2 Diabetes Mellitus)
- What is being tested?
- HSK7653
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2018to 3 Jul 2019
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≥18 and Age ≤60 years
- BMI ≥18 and BMI ≤ 25 kg/m2 (Body Mass Index)
- Able to understand the procedures of the study, provide written informed consent, and be willing to comply with the protocol of the study
Who cannot join
- Any finding of the medical examination (physical examination, laboratory examination, 12-ECG, abdominal B-ultrasonography, etc) deviating from normal and of clinical relevance during screening
- Evidence or history of clinically significant renal, gastrointestinal (including pancreatitis), hepatic disease at the time of screening
- Has a positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), Treponema pallidum antibody (TP-Ab) or human immunodeficiency virus (HIV)
- Treatment with an investigational drug within 3 months
- Fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 6 months after the last dose
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
About this study
Official title: A Single Center, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single Escalating Doses Of HSK7653 In Healthy Subjects
To evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of single dose of HSK7653 tablets in healthy adult subjects, and to identify the metabolites of HSK7653 in healthy adult subjects
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Being tested
- HSK7653, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK7653Drug
HSK7653 tablets in six doses beginning at 5 mg and rising to 150 mg
PlaceboDrug
Matching placebo tables in six doses beginning at 5 mg and rising to 150 mg
| Study group | Role | What they receive |
|---|---|---|
| HSK7653 | Experimental | Single dose, oral Receives: Drug: HSK7653 |
| Placebo | Placebo comparator | Single dose, oral Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Assessment by adverse event monitoring, 12 lead ECGs, vital signs and laboratory measurements.
Measured: First dose of study drug up to 29 days after last dose of study drug
Secondary outcomes (5)
Area Under the Curve From Time Zero to Last Quantifiable Concentration
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Measured: Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration;
Maximum Observed Plasma Concentration (Cmax)
Maximum Observed Plasma Concentration (Cmax)
Measured: Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration;
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration;
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration;
Inhibition Rate of Dipeptidyl Peptidase 4 (DPP4) Activities following single dose administration
Inhibition Rate of Dipeptidyl Peptidase 4 (DPP4) Activities following single dose administration
Measured: Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start8 May 2018
- Primary completion3 Jul 2019
- Study completion3 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T2DM (Type 2 Diabetes Mellitus)Studies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hongzhong Liu, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983289
- Sponsor's protocol ID
- HSK7653-101
- Status last verified
- Jul 2023
- First submitted
- 1 Aug 2023
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single Escalating Doses Of HSK7653 In Healthy Subjects
- ClinicalTrials.gov ID
- NCT05983289
- Acronym / sponsor ID
- HSK7653-101
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 May 2018 (actual)
- Primary completion
- 3 Jul 2019 (actual)
- Study completion
- 3 Jul 2019 (actual)
- First posted
- 9 Aug 2023 (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.
To evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of single dose of HSK7653 tablets in healthy adult subjects, and to identify the metabolites of HSK7653 in healthy adult subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSK7653 | Experimental | Drug: HSK7653Single dose, oral |
| Placebo | Placebo comparator | Drug: PlaceboSingle dose, oral |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age ≥18 and Age ≤60 years
- BMI ≥18 and BMI ≤ 25 kg/m2 (Body Mass Index)
- Able to understand the procedures of the study, provide written informed consent, and be willing to comply with the protocol of the study
Key exclusion criteria (5 listed)
- Any finding of the medical examination (physical examination, laboratory examination, 12-ECG, abdominal B-ultrasonography, etc) deviating from normal and of clinical relevance during screening
- Evidence or history of clinically significant renal, gastrointestinal (including pancreatitis), hepatic disease at the time of screening
- Has a positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), Treponema pallidum antibody (TP-Ab) or human immunodeficiency virus (HIV)
- Treatment with an investigational drug within 3 months
- Fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 6 months after the last dose
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 |
|---|---|---|
| HSK7653HSK7653 tablets in six doses beginning at 5 mg and rising to 150 mg | Drug | HSK7653 |
| PlaceboMatching placebo tables in six doses beginning at 5 mg and rising to 150 mg | Drug | Placebo |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: First dose of study drug up to 29 days after last dose of study drug
Assessment by adverse event monitoring, 12 lead ECGs, vital signs and laboratory measurements.
5 secondary outcomes
Area Under the Curve From Time Zero to Last Quantifiable Concentration
Time frame: Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration;
Maximum Observed Plasma Concentration (Cmax)
Time frame: Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration;
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration;
Plasma Decay Half-Life (t1/2)
Time frame: Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration;
Inhibition Rate of Dipeptidyl Peptidase 4 (DPP4) Activities following single dose administration
Time frame: Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single 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 9 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Hongzhong Liu principal investigator
Peking Union Medical College Hospital
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 HSK7653 in people with T2DM (Type 2 Diabetes Mellitus), run by Haisco Pharmaceutical Group 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 3 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 9 Aug 2023. 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. Some participants in this study may receive a placebo. 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?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: First dose of study drug up to 29 days after last dose of study drug). 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 9 Aug 2023.