Type 2 DiabetesPhase 1NCT05116410
A Study of HS-20094 in Healthy Participants
A Phase 1 study testing HS-20094 in people with Type 2 Diabetes, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study includes two parts (Single Ascending Dose, SAD; Multiple-Ascending Dose, MAD) and enrolls healthy participants. Participants in SAD accept single subcutaneous (SC) injection of HS-20094 and participants in MAD accept SC injection of HS-20094 once weekly for 4 weeks. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- HS-20094
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 31 Dec 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
- Screening weight of male ≥50 kg, female≥45 kg and 19≤BMI≤28
- Subjects agree to use an effective method of contraception and avoid sperm or egg donation for the duration of the study and for 6 months following the last dose of investigational product
- Agree to avoid alcohol, foods and beverages containing xanthine or caffeine (including chocolate, tea, coffee, cola, etc.) from 48 hours prior to administration to last visit, and to avoid strenuous exercise
Who cannot join
- Pregnant or lactating women
- Subjects have a medical history of cardiovascular, respiratory, liver, kidney, digestive tract, mental, neurological, hematology or metabolic abnormalities (e.g., repeated hypoglycemia for unknown reasons) and are judged not suitable for this study by the investigator.
- Subjects with abnormal screening vital signs, physical examination, laboratory examination or 12 lead electrocardiogram results with clinical significance
- Have a history of drug allergy, or known allergies to HS-20094, glucagon-like peptide (GLP)-1 analogs, or glucose-dependent insulinotropic polypeptide (GIP) receptor agonism
- Received systemic steroid therapy, immunomodulator therapy or chemotherapy in the 3 months prior to screening, or are likely to receive these treatments during the study period
- Have a history of digestive disease (e.g., gastroesophageal reflux disease, gallbladder disease, or chronic enteritis) that may affect gastrointestinal adverse events assessment or any other gastrointestinal disease (e.g., gastric bypass surgery, pyloric stenosis, etc.) that may affect gastric emptying
- Have a diet, weight loss treatment or significant lifestyle changes prior to 30 days of administration
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing University First Hospital
Beijing, Beijing Municipality, 110000
Yimin Cui, PhD, 66110802 ext. 010, cuiymzy@126.com
About this study
Official title: A Single- and Multiple-Ascending Dose Study in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-20094
This study includes two parts (Single Ascending Dose, SAD; Multiple-Ascending Dose, MAD) and enrolls healthy participants. Participants in SAD accept single subcutaneous (SC) injection of HS-20094 and participants in MAD accept SC injection of HS-20094 once weekly for 4 weeks. The main purpose of this study is to determine 1) The safety of HS-20094; 2) How much HS-20094 gets into the bloodstream and how long it takes the body to get rid of it.3) How HS-20094 affects the levels of blood sugar, insulin and weight.
- Conditions
- Type 2 Diabetes
- Being tested
- HS-20094, 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.
HS-20094Drug
Also called HS-20094 injection
Administrated SC
PlaceboDrug
Also called Placebo injection
Administrated SC
| Study group | Role | What they receive |
|---|---|---|
| HS-20094 (Single dose) | Experimental | Escalating doses of HS-20094 administered subcutaneously (SC) once in healthy participants. Receives: Drug: HS-20094 |
| HS-20094 (Multiple doses) | Experimental | Escalating doses of HS-20094 administered SC once weekly for four weeks in healthy participants. Receives: Drug: HS-20094 |
| Placebo (Single dose) | Placebo comparator | Placebo administered SC once in healthy participants. Receives: Drug: Placebo |
| Placebo (Multiple doses) | Placebo comparator | Placebo administered SC once weekly for four weeks in healthy participants. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse event (AE), serious adverse event (SAE), AE leading to study discontinuation, AE severity and relation with study drug
A summary of AEs and SAEs, AE leading to study discontinuation, AE severity and relation with study drug will be reported in the reported adverse events module
Measured: Time of Inform Consent Form to Day 29 (SAD) or Day 50 (MAD)
Secondary outcomes (6)
Pharmacokinetics (PK): Cmax of HS-20094
PK: Cmax of HS-20094
Measured: Baseline to Day 22 (SAD) or Day 43 (MAD)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of HS-20094
PK: AUC of HS-20094
Measured: Baseline to Day 22 (SAD) or Day 43 (MAD)
Pharmacokinetics (PK): Tmax of HS-20094
PK: Tmax of HS-20094
Measured: Baseline to Day 22 (SAD) or Day 43 (MAD)
Pharmacodynamics (PD): AUC of glucose
PD: AUC of glucose
Measured: Day 22 (MAD)
Pharmacodynamics (PD): AUC of insulin
PD: AUC of insulin
Measured: Day 22 (MAD)
Weight change
Measured: baseline to Day 29 (SAD) or Day 50 (MAD)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start1 Nov 2021
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
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 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yimin Cui, Principal investigator, Beijing University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116410
- Sponsor's protocol ID
- HS-20094-101
- Status last verified
- Oct 2021
- First submitted
- 29 Oct 2021
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single- and Multiple-Ascending Dose Study in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-20094
- ClinicalTrials.gov ID
- NCT05116410
- Acronym / sponsor ID
- HS-20094-101
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 11 Nov 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.
This study includes two parts (Single Ascending Dose, SAD; Multiple-Ascending Dose, MAD) and enrolls healthy participants. Participants in SAD accept single subcutaneous (SC) injection of HS-20094 and participants in MAD accept SC injection of HS-20094 once weekly for 4 weeks. The main purpose of this study is to determine 1) The safety of HS-20094; 2) How much HS-20094 gets into the bloodstream and how long it takes the body to get rid of it.3) How HS-20094 affects the levels of blood sugar, insulin and weight.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HS-20094 (Single dose) | Experimental | Drug: HS-20094Escalating doses of HS-20094 administered subcutaneously (SC) once in healthy participants. |
| HS-20094 (Multiple doses) | Experimental | Drug: HS-20094Escalating doses of HS-20094 administered SC once weekly for four weeks in healthy participants. |
| Placebo (Single dose) | Placebo comparator | Drug: PlaceboPlacebo administered SC once in healthy participants. |
| Placebo (Multiple doses) | Placebo comparator | Drug: PlaceboPlacebo administered SC once weekly for four weeks in healthy participants. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Screening weight of male ≥50 kg, female≥45 kg and 19≤BMI≤28
- Subjects agree to use an effective method of contraception and avoid sperm or egg donation for the duration of the study and for 6 months following the last dose of investigational product
- Agree to avoid alcohol, foods and beverages containing xanthine or caffeine (including chocolate, tea, coffee, cola, etc.) from 48 hours prior to administration to last visit, and to avoid strenuous exercise
Key exclusion criteria (7 listed)
- Pregnant or lactating women
- Subjects have a medical history of cardiovascular, respiratory, liver, kidney, digestive tract, mental, neurological, hematology or metabolic abnormalities (e.g., repeated hypoglycemia for unknown reasons) and are judged not suitable for this study by the investigator.
- Subjects with abnormal screening vital signs, physical examination, laboratory examination or 12 lead electrocardiogram results with clinical significance
- Have a history of drug allergy, or known allergies to HS-20094, glucagon-like peptide (GLP)-1 analogs, or glucose-dependent insulinotropic polypeptide (GIP) receptor agonism
- Received systemic steroid therapy, immunomodulator therapy or chemotherapy in the 3 months prior to screening, or are likely to receive these treatments during the study period
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-20094Also: HS-20094 injectionAdministrated SC | Drug | HS-20094 (Multiple doses), HS-20094 (Single dose) |
| PlaceboAlso: Placebo injectionAdministrated SC | Drug | Placebo (Multiple doses), Placebo (Single dose) |
Primary outcome
Incidence of adverse event (AE), serious adverse event (SAE), AE leading to study discontinuation, AE severity and relation with study drug
Time frame: Time of Inform Consent Form to Day 29 (SAD) or Day 50 (MAD)
A summary of AEs and SAEs, AE leading to study discontinuation, AE severity and relation with study drug will be reported in the reported adverse events module
6 secondary outcomes
Pharmacokinetics (PK): Cmax of HS-20094
Time frame: Baseline to Day 22 (SAD) or Day 43 (MAD)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of HS-20094
Time frame: Baseline to Day 22 (SAD) or Day 43 (MAD)
Pharmacokinetics (PK): Tmax of HS-20094
Time frame: Baseline to Day 22 (SAD) or Day 43 (MAD)
Pharmacodynamics (PD): AUC of glucose
Time frame: Day 22 (MAD)
Pharmacodynamics (PD): AUC of insulin
Time frame: Day 22 (MAD)
Weight change
Time frame: baseline to Day 29 (SAD) or Day 50 (MAD)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- 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.
Yimin Cui principal investigator
Beijing University First 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 HS-20094 in people with Type 2 Diabetes, run by Jiangsu Hansoh Pharmaceutical 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 7 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: status not confirmed, as of the sponsor's last update on 19 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yimin Cui, PhD (66110802 ext. 010, cuiymzy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse event (AE), serious adverse event (SAE), AE leading to study discontinuation, AE severity and relation with study drug (time frame: Time of Inform Consent Form to Day 29 (SAD) or Day 50 (MAD)). 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 19 Jul 2022.