HealthyPhase 1NCT02746315

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple s.c Doses HS-20004 in Healthy Chinese Volunteers

A Phase 1 study testing HS-20004 in people with Healthy, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This trial is conducted in China. The aim of this trial is to assess the safety and tolerability for Multiple s.c injection of HS-20004 in healthy Chinese subjects Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: HS-20004
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: No sites listed yet
Study dates: Oct 2014to Feb 2015
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

Body Mass Index (BMI) between 19 and 28 kg/m^2, inclusive, and a total body weight of at least 50 kg;

Who cannot join

Clinically relevant abnormalities of physical examination, laboratory values, vital signs or ECG findings at the screening, as judged by the Investigator;
Have any other medical abnormality (such as cardiovascular, hepatic, renal, gastrointestinal, immunologic, hematological, hormonal, metabolic, neoplasmatic or mental disease), which in the opinion of the investigator, might affect the absorption, distribution, metabolism, and excretion of the study drug, or prevent the patient from following and completing the protocol;
Family history of diabetes, thyroid cancer, submandibular gland cancer, or history of pancreatitis, cholelithiasis, drug allergy, serious unconscious hypoglycemia or positive of anxious chronic viral hepatitis B, HIV antibody;
History of drug or alcohol abuse within 6 months before randomization;
Use of GLP-1 analogues, DPP-IV enzyme inhibitors, as well as other hypoglycemic drugs within 3 months before randomization;
Use of any prescription drugs and Chinese herbal medicines within 4 weeks before randomization;

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Use of non prescription drugs and food supplements (vitamins, etc.) within 2 weeks before randomization;
Participated any drug clinical trials within 3 months, or participated 3 or more than 3 drug clinical trials within 1 year, or had blood donation/loss >400mL within 3 months before randomization;
Female subject of childbearing potential who does not use an acceptable method of birth control, is pregnant or planning a pregnancy, or breastfeeding, or male subject who does not use an acceptable method of birth control, within six months before randomization;
Subject who cannot refrain from smoking, eating and/or drinking containing xanthine/caffeine, or strenuous exercise, or others that affect drug absorption, distribution, metabolism and excretion within 2 days before the study drug administration; Subject who is unsuitable for inclusion in the study in the opinion of the investigator;

About this study

Official title: A Randomised, Double-blind, Single-centre, Placebo-controlled, Dose Escalation, Multiple s.c. DoseStudy to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HS-20004 in Healthy Chinese Subjects

This trial is conducted in China. The aim of this trial is to assess the safety and tolerability for Multiple s.c injection of HS-20004 in healthy Chinese subjects

Conditions: Healthy
Being tested: HS-20004, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HS-20004Drug
PlaceboDrug

Study groups in NCT02746315
Study group	Role	What they receive
Experimental 1	Experimental	Once daily subcutaneous dose for 7 Days of HS-20004 0.02 mg or Matched Placebo. Receives: Drug: HS-20004; Drug: Placebo
Experimental 2	Experimental	Once daily subcutaneous dose for 7 Days of HS-20004 0.04 mg or Matched Placebo. Receives: Drug: HS-20004; Drug: Placebo
Experimental 3	Experimental	Once daily subcutaneous dose for 7 Days of HS-20004 0.06 mg or Matched Placebo. Receives: Drug: HS-20004; Drug: Placebo
Experimental 4	Experimental	Once daily subcutaneous dose for 7 Days of HS-20004 0.08 mg or Matched Placebo. Receives: Drug: HS-20004; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of treatment emergent adverse events (TEAEs)
Measured: Day 0 and up to 3 days after last treatment (Day 10)

Secondary outcomes (4)

Area under the plasma HS-20004 concentration curve after the last s.c injection
Measured: Time 0 to 72 hours after the last dose
Peak plasma concentration (Cmax) after the last dose
Measured: Time 0 to 72 hours after the last treatment
Terminal elimination half-life (t½) for HS-20004 after the last dose
Measured: Time 0 to 72 hours after the last treatment
Change in 24-hour profiles of plasma glucose and serum insulin from baseline
Measured: From time 0 to 24 hours after the first and last treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2014Feb 2015

First posted21 Apr 2016 (estimated)
Study startOct 2014
Primary completionFeb 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Jiangsu Hansoh Pharmaceutical 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: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02746315
Sponsor's protocol ID: HS-20004-Ib
Status last verified: Apr 2016
First submitted: 11 Apr 2016
Last updated: 21 Apr 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Single-centre, Placebo-controlled, Dose Escalation, Multiple s.c. DoseStudy to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HS-20004 in Healthy Chinese Subjects
ClinicalTrials.gov ID: NCT02746315
Acronym / sponsor ID: HS-20004-Ib
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: Oct 2014
Primary completion: Feb 2015 (actual)
First posted: 21 Apr 2016 (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.

This trial is conducted in China. The aim of this trial is to assess the safety and tolerability for Multiple s.c injection of HS-20004 in healthy Chinese subjects

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Experimental 1	Experimental	Drug: HS-20004, Drug: PlaceboOnce daily subcutaneous dose for 7 Days of HS-20004 0.02 mg or Matched Placebo.
Experimental 2	Experimental	Drug: HS-20004, Drug: PlaceboOnce daily subcutaneous dose for 7 Days of HS-20004 0.04 mg or Matched Placebo.
Experimental 3	Experimental	Drug: HS-20004, Drug: PlaceboOnce daily subcutaneous dose for 7 Days of HS-20004 0.06 mg or Matched Placebo.
Experimental 4	Experimental	Drug: HS-20004, Drug: PlaceboOnce daily subcutaneous dose for 7 Days of HS-20004 0.08 mg or Matched Placebo.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Body Mass Index (BMI) between 19 and 28 kg/m^2, inclusive, and a total body weight of at least 50 kg;

Key exclusion criteria (10 listed)

Clinically relevant abnormalities of physical examination, laboratory values, vital signs or ECG findings at the screening, as judged by the Investigator;
Have any other medical abnormality (such as cardiovascular, hepatic, renal, gastrointestinal, immunologic, hematological, hormonal, metabolic, neoplasmatic or mental disease), which in the opinion of the investigator, might affect the absorption, distribution, metabolism, and excretion of the study drug, or prevent the patient from following and completing the protocol;
Family history of diabetes, thyroid cancer, submandibular gland cancer, or history of pancreatitis, cholelithiasis, drug allergy, serious unconscious hypoglycemia or positive of anxious chronic viral hepatitis B, HIV antibody;
History of drug or alcohol abuse within 6 months before randomization;
Use of GLP-1 analogues, DPP-IV enzyme inhibitors, as well as other hypoglycemic drugs within 3 months before randomization;

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
HS-20004	Drug	Experimental 1, Experimental 2, Experimental 3, Experimental 4
Placebo	Drug	Experimental 1, Experimental 2, Experimental 3, Experimental 4

Primary outcome

Number of treatment emergent adverse events (TEAEs)
Time frame: Day 0 and up to 3 days after last treatment (Day 10)

4 secondary outcomes

Area under the plasma HS-20004 concentration curve after the last s.c injection
Time frame: Time 0 to 72 hours after the last dose
Peak plasma concentration (Cmax) after the last dose
Time frame: Time 0 to 72 hours after the last treatment
Terminal elimination half-life (t½) for HS-20004 after the last dose
Time frame: Time 0 to 72 hours after the last treatment
Change in 24-hour profiles of plasma glucose and serum insulin from baseline
Time frame: From time 0 to 24 hours after the first and last treatment

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 21 Apr 2016.
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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HS-20004 in people with Healthy, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..

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 1 inclusion and 10 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 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

Number of treatment emergent adverse events (TEAEs) (time frame: Day 0 and up to 3 days after last treatment (Day 10)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02746315.

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 21 Apr 2016.