Type II Diabetes MellitusPhase 1NCT01952535
A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of Oral HMS5552 in Healthy Volunteers
A Phase 1 study testing HMS5552 in people with Type II Diabetes Mellitus, run by Hua Medicine Limited at 1 site in China.
Trial summary
The objectives of this study is to determine the safety profiles, tolerability, pharmacokinetics and pharmacodynamics of HMS5552 following single ascending doses in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Type II Diabetes Mellitus
- What is being tested?
- HMS5552
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Dec 2013
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female and male volunteers, 18 to 45 years of age
- BMI: 18 to 24 kg/m2
- Fasting plasma glucose: 3.9 to 6.1 mmol/L
- Glucose level at 2 hours following oral glucose tolerance test <7.8 mmol/L
- HbA1c: 4 to 6.5%
- Normal supine blood pressure and normal ECG recordings
Who cannot join
- Female with child-bearing potential
- Evidence of clinically-significant renal, cardiac, bronchopulmonary, vascular, gastrointestinal, allergic, neurologic, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency disorders, cancer, hepatitis or cirrhosis.
- Intake of grapefruit or anything that may affect liver enzyme function within 1 month prior to the dosing day
- Clinically-relevant deviation from normal in the physical examination
- Subjects with a medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Study of Administrating Single Ascending Dose of HMS5552 in Healthy Adult Volunteers
The objectives of this study is to determine the safety profiles, tolerability, pharmacokinetics and pharmacodynamics of HMS5552 following single ascending doses in healthy adult subjects.
Read the detailed description
This will be a randomized, double-blind and placebo-controlled safety study with single oral doses of HMS5552 given to healthy volunteers.
The primary objective is to characterize the safety profiles of HMS5552 following single ascending doses (SAD) in healthy adult subjects.
The secondary objectives include:
- To assess the pharmacokinetic profiles of HMS5552 after single dosing
- To assess the preliminary pharmacodynamic profiles of HMS5552
Each study subject will receive a single oral dose of HMS5552. During each dosing, eight subjects will be allocated to receive HMS5552 and two subjects will be allocated to receive placebo treatment.
Several doses of HMS5552 will be tested. Dose titration or reduction is determined for each cohort based on the safety and pharmacokinetic data obtained from the lower dose cohorts.
- Conditions
- Type II Diabetes Mellitus
- Being tested
- HMS5552, 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.
HMS5552Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| HMS5552 dose 1 | Experimental | A single dose of HMS5552 tablets (5~50mg) taken orally. Receives: Drug: HMS5552; Drug: Placebo |
| HMS5552 dose 2 | Experimental | A single dose of HMS5552 tablets (5~50mg) taken orally. Receives: Drug: HMS5552; Drug: Placebo |
| HMS5552 dose 3 | Experimental | A single dose of HMS5552 tablets (5~50mg) taken orally. Receives: Drug: HMS5552; Drug: Placebo |
| HMS5552 dose 4 | Experimental | A single dose of HMS5552 tablets (5~50mg) taken orally. Receives: Drug: HMS5552; Drug: Placebo |
| HMS5552 dose 5 | Experimental | A single dose of HMS5552 tablets (5~50mg) taken orally. Receives: Drug: HMS5552; Drug: Placebo |
| HMS5552 dose 6 | Experimental | A single dose of HMS5552 tablets (5~50mg) taken orally. Receives: Drug: HMS5552; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of HMS5552 will be assessed by adverse event monitoring, physical examinations, 12 lead ECGs, vital sign, and safety laboratory measurements.
Measured: up to 72 hours post-dose
Secondary outcomes (2)
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of AUCinf, AUC0-t, Cmax, Tmax, Ae, T1/2.
Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hour post-dose. Urine will be collected at predose, 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, and 48 to 72 hour post-dose.
Measured: up to 72 hours post-dose
Pharmacodynamic variables will include maximum change (%) in fasting plasma glucose level, AUC0-4 of fasting plasma glucose , AUC of percent reduction in fasting plasma glucose from baseline versus time curve, time of minimum glucose level
Measured: up to 6 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hua Medicine Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- XueNing LI, MD, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952535
- Sponsor's protocol ID
- HMM0101
- Status last verified
- Nov 2017
- First submitted
- 22 Sep 2013
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Study of Administrating Single Ascending Dose of HMS5552 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01952535
- Acronym / sponsor ID
- HMM0101
- Conditions
- Type II Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hua Medicine LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Sep 2013 (estimated)
- 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 objectives of this study is to determine the safety profiles, tolerability, pharmacokinetics and pharmacodynamics of HMS5552 following single ascending doses in healthy adult subjects.
Detailed description
This will be a randomized, double-blind and placebo-controlled safety study with single oral doses of HMS5552 given to healthy volunteers.
The primary objective is to characterize the safety profiles of HMS5552 following single ascending doses (SAD) in healthy adult subjects.
The secondary objectives include:
- To assess the pharmacokinetic profiles of HMS5552 after single dosing
- To assess the preliminary pharmacodynamic profiles of HMS5552
Each study subject will receive a single oral dose of HMS5552. During each dosing, eight subjects will be allocated to receive HMS5552 and two subjects will be allocated to receive placebo treatment.
Several doses of HMS5552 will be tested. Dose titration or reduction is determined for each cohort based on the safety and pharmacokinetic data obtained from the lower dose cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| HMS5552 dose 1 | Experimental | Drug: HMS5552, Drug: PlaceboA single dose of HMS5552 tablets (5~50mg) taken orally. |
| HMS5552 dose 2 | Experimental | Drug: HMS5552, Drug: PlaceboA single dose of HMS5552 tablets (5~50mg) taken orally. |
| HMS5552 dose 3 | Experimental | Drug: HMS5552, Drug: PlaceboA single dose of HMS5552 tablets (5~50mg) taken orally. |
| HMS5552 dose 4 | Experimental | Drug: HMS5552, Drug: PlaceboA single dose of HMS5552 tablets (5~50mg) taken orally. |
| HMS5552 dose 5 | Experimental | Drug: HMS5552, Drug: PlaceboA single dose of HMS5552 tablets (5~50mg) taken orally. |
| HMS5552 dose 6 | Experimental | Drug: HMS5552, Drug: PlaceboA single dose of HMS5552 tablets (5~50mg) taken orally. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female and male volunteers, 18 to 45 years of age
- BMI: 18 to 24 kg/m2
- Fasting plasma glucose: 3.9 to 6.1 mmol/L
- Glucose level at 2 hours following oral glucose tolerance test <7.8 mmol/L
- HbA1c: 4 to 6.5%
Key exclusion criteria (5 listed)
- Female with child-bearing potential
- Evidence of clinically-significant renal, cardiac, bronchopulmonary, vascular, gastrointestinal, allergic, neurologic, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency disorders, cancer, hepatitis or cirrhosis.
- Intake of grapefruit or anything that may affect liver enzyme function within 1 month prior to the dosing day
- Clinically-relevant deviation from normal in the physical examination
- Subjects with a medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator
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 |
|---|---|---|
| HMS5552 | Drug | HMS5552 dose 1, HMS5552 dose 2, HMS5552 dose 3, HMS5552 dose 4, HMS5552 dose 5, HMS5552 dose 6 |
| Placebo | Drug | HMS5552 dose 1, HMS5552 dose 2, HMS5552 dose 3, HMS5552 dose 4, HMS5552 dose 5, HMS5552 dose 6 |
Primary outcome
Safety and tolerability of HMS5552 will be assessed by adverse event monitoring, physical examinations, 12 lead ECGs, vital sign, and safety laboratory measurements.
Time frame: up to 72 hours post-dose
2 secondary outcomes
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of AUCinf, AUC0-t, Cmax, Tmax, Ae, T1/2.
Time frame: up to 72 hours post-dose
Pharmacodynamic variables will include maximum change (%) in fasting plasma glucose level, AUC0-4 of fasting plasma glucose , AUC of percent reduction in fasting plasma glucose from baseline versus time curve, time of minimum glucose level
Time frame: up to 6 hours post-dose
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 20 Nov 2017.
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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.
XueNing LI, MD principal investigator
Shanghai Zhongshan 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 HMS5552 in people with Type II Diabetes Mellitus, run by Hua Medicine Limited 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 6 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 20 Nov 2017. 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?
Safety and tolerability of HMS5552 will be assessed by adverse event monitoring, physical examinations, 12 lead ECGs, vital sign, and safety laboratory measurements. (time frame: up to 72 hours post-dose). 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 20 Nov 2017.