Type 2 DiabetesPhase 1NCT06634927
Pharmacokinetic Similarity, Safety, and Immunogenicity of Semaglutide Injection and Ozempic ® Injection in Healthy Subjects.
A Phase 1 study testing Ozempic® and HDG1901 in people with Type 2 Diabetes, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is a randomized, open-label, single-dose, parallel-controlled biosimilar comparison study comparing the pharmacokinetics, safety and immunogenicity of the investigational drug and the active comparator in healthy adult subjects. 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?
- Ozempic® and HDG1901
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 22 Sep 2024to 12 Feb 2025
- 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
- Participants must meet all of the following criteria to be enrolled in the study:
- Voluntarily participate in the trial and sign the informed consent; Willing and able, in the investigator\'s judgment, to comply with all experimental requirements and restrictions;
- Healthy men and women, aged 18 to 55 years old (including);
- Body mass index (BMI) 19.0~25.0 kg/m2 (including), weight ≥50.0 kg;
- Physical examination, vital signs, 12-lead electrocardiogram (ECG), clinical laboratory examination, no clinically significant abnormalities;
Who cannot join
- Subjects who meet any of the following criteria will be excluded:
- Have a history of clinically serious disease or currently have any clinically significant cardiovascular, metabolic, endocrine, kidney, liver, gastrointestinal, hematological, respiratory, cutaneous, neurological, gynecological, psychiatric or other disease;
- A history of medullary thyroid carcinoma (MTC), multiple endocrine adenoma (MEN) 2A or 2B syndrome, or related family history; Or other malignant tumor history;
- Subjects with a history of acute and chronic pancreatitis, symptomatic gallbladder history, pancreatic injury history and other high-risk factors that may lead to pancreatitis;
- In the screening period, calcitonin was greater than the upper limit of normal;
- Patients with HbA1c greater than 6.5% during the screening period;
Show all 19Show fewer
- Those who smoked more than 5 cigarettes per day in the 3 months before screening and those who could not smoke during the whole test period;
- Those who have a history of alcohol abuse in the six months prior to screening, or who cannot abstain from alcohol during the test period;
- Consume any food or drink containing caffeine, alcohol, xanthine or grapefruit (such as coffee, strong tea, chocolate, etc.) within 48 hours before check-in;
- Known or suspected allergy to semaglutide injection or similar products and excipients;
- Participants in clinical trials of any approved or unapproved investigational drug/device within 90 days prior to screening;
- Pregnant and lactating female subjects;
- Patients with difficulty in venous blood collection;
- Those who were vaccinated within 4 weeks prior to screening or planned to be vaccinated during the trial;
- People who donate blood or lose more than 400 mL of blood or receive blood transfusions or use blood products in the 3 months prior to screening;
- Patients who have previously received Semaglutide injection or other GLP-1 or GLP-1/ GIP-like treatment;
- Those who have a history of drug abuse or test positive for drug abuse screening;
- Those who test positive for blood alcohol;
- For any other reason, the investigator does not consider the volunteer to be suitable for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601
About this study
Official title: A Randomized, Open-label, Single-dose, Parallel-controlled Phase I Clinical Trial Comparing the Pharmacokinetic Similarity, Safety, and Immunogenicity of Semaglutide Injection and Ozempic ® Injection in Healthy Subjects.
This study is a randomized, open-label, single-dose, parallel-controlled biosimilar comparison study comparing the pharmacokinetics, safety and immunogenicity of the investigational drug and the active comparator in healthy adult subjects. Eligible healthy participants will be screened and randomly assigned to the experimental group and the active comparator group at a ratio of 1:1 , semaglutide injection or Ozempic® injection 0.25mg abdominal subcutaneous injection will be given according to their groups. Follow-up for 5 weeks after administrtion.
Studies included a screening period (up to 2 weeks), baseline, administration (single dose), and a follow-up period (5 weeks). The duration of the study will be approximately 7 weeks for a participant.
- Conditions
- Type 2 Diabetes
- Being tested
- Ozempic®, HDG1901
- Keywords
- Glucagon-Like Peptide-1 Receptor Agonists, semaglutide
- 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.
Ozempic®Drug
Participants will be given Ozempic ® injection 0.25mg abdominal subcutaneous injection.
HDG1901Drug
Participants will be given HDG1901 injection 0.25mg abdominal subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental group: Semaglutide injection, specifications: 1.34 mg/mL, 1.5 mL (pre-filled injection pen), 0.25 mg , subcutaneous abdominal injection. Receives: Drug: HDG1901 |
| Active Comparator | Active comparator | Control group: Ozempic ® injection, 1.34 mg/mL, 1.5 mL (pre-filled injection pen), 0.25 mg , subcutaneous injection into the abdomen. Receives: Drug: Ozempic® |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-inf
Area Under the Concentration-time curve from time zero to infinite time
Measured: -60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration
AUC0-t
Area Under the Concentration-time curve from time zero to the last measurable concentration
Measured: -60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration
Cmax
Maximum concentration of the active substance in the blood plasma of participants during the observation period
Measured: -60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration
Secondary outcomes (6)
AUC_%Extrap
Extrapolated Part Percentage of AUC0-inf
Measured: -60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration
Tmax
Time of maximum concentration observed
Measured: -60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration
t 1/2
Elimination half life
Measured: -60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration
λz
The Volume of Distribution at Terminal Phase
Measured: -60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration
CL
Clearance Rate
Measured: -60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration
Safety and Immunogenicity
Adverse events and positive rate of anti-drug antibodies
Measured: AEs will be collected after assigning the ICF. Immunogenicity sample will be collected at -60 minutes and 336、840 hours after administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start22 Sep 2024
- Primary completion14 Nov 2024
- Study completion12 Feb 2025
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 Hangzhou Zhongmei Huadong 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
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634927
- Sponsor's protocol ID
- HDG1901-103
- Status last verified
- Sep 2024
- First submitted
- 24 Sep 2024
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, Parallel-controlled Phase I Clinical Trial Comparing the Pharmacokinetic Similarity, Safety, and Immunogenicity of Semaglutide Injection and Ozempic ® Injection in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT06634927
- Acronym / sponsor ID
- HDG1901-103
- Conditions
- Type 2 Diabetes
- Keywords
- Glucagon-Like Peptide-1 Receptor Agonists, semaglutide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Sep 2024 (actual)
- Primary completion
- 14 Nov 2024 (actual)
- Study completion
- 12 Feb 2025 (actual)
- First posted
- 10 Oct 2024 (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 is a randomized, open-label, single-dose, parallel-controlled biosimilar comparison study comparing the pharmacokinetics, safety and immunogenicity of the investigational drug and the active comparator in healthy adult subjects. Eligible healthy participants will be screened and randomly assigned to the experimental group and the active comparator group at a ratio of 1:1 , semaglutide injection or Ozempic® injection 0.25mg abdominal subcutaneous injection will be given according to their groups. Follow-up for 5 weeks after administrtion.
Studies included a screening period (up to 2 weeks), baseline, administration (single dose), and a follow-up period (5 weeks). The duration of the study will be approximately 7 weeks for a participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: HDG1901Experimental group: Semaglutide injection, specifications: 1.34 mg/mL, 1.5 mL (pre-filled injection pen), 0.25 mg , subcutaneous abdominal injection. |
| Active Comparator | Active comparator | Drug: Ozempic®Control group: Ozempic ® injection, 1.34 mg/mL, 1.5 mL (pre-filled injection pen), 0.25 mg , subcutaneous injection into the abdomen. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Voluntarily participate in the trial and sign the informed consent; Willing and able, in the investigator\'s judgment, to comply with all experimental requirements and restrictions;
- Healthy men and women, aged 18 to 55 years old (including);
- Body mass index (BMI) 19.0~25.0 kg/m2 (including), weight ≥50.0 kg;
- Physical examination, vital signs, 12-lead electrocardiogram (ECG), clinical laboratory examination, no clinically significant abnormalities;
Key exclusion criteria (19 listed)
- Have a history of clinically serious disease or currently have any clinically significant cardiovascular, metabolic, endocrine, kidney, liver, gastrointestinal, hematological, respiratory, cutaneous, neurological, gynecological, psychiatric or other disease;
- A history of medullary thyroid carcinoma (MTC), multiple endocrine adenoma (MEN) 2A or 2B syndrome, or related family history; Or other malignant tumor history;
- Subjects with a history of acute and chronic pancreatitis, symptomatic gallbladder history, pancreatic injury history and other high-risk factors that may lead to pancreatitis;
- In the screening period, calcitonin was greater than the upper limit of normal;
- Patients with HbA1c greater than 6.5% during the screening 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 |
|---|---|---|
| Ozempic®Participants will be given Ozempic ® injection 0.25mg abdominal subcutaneous injection. | Drug | Active Comparator |
| HDG1901Participants will be given HDG1901 injection 0.25mg abdominal subcutaneous injection. | Drug | Experimental group |
Primary outcome
AUC0-inf
Time frame: -60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration
Area Under the Concentration-time curve from time zero to infinite time
AUC0-t
Time frame: -60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration
Area Under the Concentration-time curve from time zero to the last measurable concentration
Cmax
Time frame: -60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration
Maximum concentration of the active substance in the blood plasma of participants during the observation period
6 secondary outcomes
AUC_%Extrap
Time frame: -60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration
Tmax
Time frame: -60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration
t 1/2
Time frame: -60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration
λz
Time frame: -60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration
CL
Time frame: -60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration
Safety and Immunogenicity
Time frame: AEs will be collected after assigning the ICF. Immunogenicity sample will be collected at -60 minutes and 336、840 hours after 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 1 Aug 2025.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
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 Ozempic® and HDG1901 in people with Type 2 Diabetes, run by Hangzhou Zhongmei Huadong 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 5 inclusion and 19 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 1 Aug 2025. 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?
AUC0-inf (time frame: -60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration). The study lists 3 primary outcomes in all. 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 1 Aug 2025.