Type 2 DiabetesPhase 1NCT03199261
A Study of Pharmacokinetic Comparison of Two Recombinant Exendin-4 Formulations in Chinese Healthy Male Subjects
A Phase 1 study testing rE-4 Injection and rE-4 Freeze-dried Powder in people with Type 2 Diabetes, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
Evaluation of the pharmacokinetics and safety rE-4 Injection versus rE-4 Freeze-dried Powder in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- rE-4 Injection and rE-4 Freeze-dried Powder
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 23 Dec 2016to 21 Jan 2017
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male adult volunteers of 18-45 years old, who can be inserted needle.
- Body mass index (BMI) of 19 to 26 kg/m2, inclusive BMI = weight (kg)/[height(m)]2，During Screening period body weight≥50 kg.
- Subjects are fully informed and voluntarily consent to participate in this study.
Who cannot join
- A positive result in hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test.
- History or presence of neurological, cardiovascular, renal, hepatic, pancreatic,gastrointestinal, pulmonary, metabolic, or musculoskeletal diseases.
- History or presence neurological disorder disease.
- Abnormal laboratory profiles, routine inspection, vitl signs and ECGs results with clinical significance.
- Participation in a clinical drug study 30 days prior to present study.
- FPG≥6.1mmol/L or <3.9mmol/L.
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- SBP<90mmHg or >140mmHg; DBP>90mmHg.
- Use of any other drugs,vitamine and mineral substance.
- Blood donation more than 200 mL blood within 3 months prior to the study.
- Smoker (>5 cigarettes/day) or alcoholist (355 ml alcohol/day).
- History or Family history of hypoglycemia.
- History of allergy or hypersensitivity.
- Subjects planning to give birth or donate sperm during the study or within 3 months after the study.
- Other unfavorable factors diagnosed by investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Pharmacokinetic Comparison and Bioequivalence Evaluation of Two 10-µg Recombinant Exendin-4 Formulations in Chinese Healthy Male Subjects
Evaluation of the pharmacokinetics and safety rE-4 Injection versus rE-4 Freeze-dried Powder in healthy subjects.
Read the detailed description
The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study with a washout period of 7 days. During each session, the subjects will receive a subcutaneous single dose of rE-4 (rE-4 Injection 10µg or rE-4 Freeze-dried Powder 10µg) administered 30min prior to the start time of a standard breakfast.
- Conditions
- Type 2 Diabetes
- Being tested
- rE-4 Injection, rE-4 Freeze-dried Powder
- 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.
rE-4 InjectionDrug
Also called Recombinant Exendin-4 Injection
During the study session, healthy subjects will be receive a subcutaneous single dose of rE-4 Injection 10µg administered 30 minutes prior to the start time of a standard breakfast.
rE-4 Freeze-dried PowderDrug
Also called Recombinant Exendin-4 Freeze-dried Powder
During the study session, healthy subjects will be receive a subcutaneous single dose of rE-4 Freeze-dried Powder 10µg administered 30 minutes prior to the start time of a standard breakfast.
| Study group | Role | What they receive |
|---|---|---|
| rE-4 Injection | Experimental | 10µg, rE-4 Injection, 30 minutes prior to the start time of a standard breakfast. Receives: Drug: rE-4 Injection |
| rE-4 Freeze-dried Powder | Active comparator | 10µg, rE-4 Freeze-dried Powder, 30 minutes prior to the start time of a standard breakfast. Receives: Drug: rE-4 Freeze-dried Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalency between the 2 formulations of rE-4
Area under curve
Measured: before injection and 0.25,0.5,0.75,1.0,1.5，2.0,3.0,4.0,6.0,8.0hour post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start23 Dec 2016
- Primary completion21 Jan 2017
- Study completion21 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology 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
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hengyan Qu, Ph.D, Principal investigator, The Affiliated Hospital Military Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199261
- Sponsor's protocol ID
- SN-YQ-2016018
- Status last verified
- Dec 2016
- First submitted
- 17 Jan 2017
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetic Comparison and Bioequivalence Evaluation of Two 10-µg Recombinant Exendin-4 Formulations in Chinese Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03199261
- Acronym / sponsor ID
- SN-YQ-2016018
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Dec 2016
- Primary completion
- 21 Jan 2017 (actual)
- Study completion
- 21 Jan 2017 (actual)
- First posted
- 26 Jun 2017 (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.
Evaluation of the pharmacokinetics and safety rE-4 Injection versus rE-4 Freeze-dried Powder in healthy subjects.
Detailed description
The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study with a washout period of 7 days. During each session, the subjects will receive a subcutaneous single dose of rE-4 (rE-4 Injection 10µg or rE-4 Freeze-dried Powder 10µg) administered 30min prior to the start time of a standard breakfast.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rE-4 Injection | Experimental | Drug: rE-4 Injection10µg, rE-4 Injection, 30 minutes prior to the start time of a standard breakfast. |
| rE-4 Freeze-dried Powder | Active comparator | Drug: rE-4 Freeze-dried Powder10µg, rE-4 Freeze-dried Powder, 30 minutes prior to the start time of a standard breakfast. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male adult volunteers of 18-45 years old, who can be inserted needle.
- Body mass index (BMI) of 19 to 26 kg/m2, inclusive BMI = weight (kg)/[height(m)]2，During Screening period body weight≥50 kg.
- Subjects are fully informed and voluntarily consent to participate in this study.
Key exclusion criteria (14 listed)
- A positive result in hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test.
- History or presence of neurological, cardiovascular, renal, hepatic, pancreatic,gastrointestinal, pulmonary, metabolic, or musculoskeletal diseases.
- History or presence neurological disorder disease.
- Abnormal laboratory profiles, routine inspection, vitl signs and ECGs results with clinical significance.
- Participation in a clinical drug study 30 days prior to present 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 |
|---|---|---|
| rE-4 InjectionAlso: Recombinant Exendin-4 InjectionDuring the study session, healthy subjects will be receive a subcutaneous single dose of rE-4 Injection 10µg administered 30 minutes prior to the start time of a standard breakfast. | Drug | rE-4 Injection |
| rE-4 Freeze-dried PowderAlso: Recombinant Exendin-4 Freeze-dried PowderDuring the study session, healthy subjects will be receive a subcutaneous single dose of rE-4 Freeze-dried Powder 10µg administered 30 minutes prior to the start time of a standard breakfast. | Drug | rE-4 Freeze-dried Powder |
Primary outcome
Bioequivalency between the 2 formulations of rE-4
Time frame: before injection and 0.25,0.5,0.75,1.0,1.5，2.0,3.0,4.0,6.0,8.0hour post-injection
Area under curve
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 26 Jun 2017.
- 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.
Hengyan Qu, Ph.D principal investigator
The Affiliated Hospital Military Medical Sciences
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 rE-4 Injection and rE-4 Freeze-dried Powder in people with Type 2 Diabetes, run by CSPC ZhongQi Pharmaceutical Technology 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 14 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 26 Jun 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?
Bioequivalency between the 2 formulations of rE-4 (time frame: before injection and 0.25,0.5,0.75,1.0,1.5，2.0,3.0,4.0,6.0,8.0hour post-injection). 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 26 Jun 2017.