Overweight and/or ObesityPhase 1NCT07828197
A Pharmacokinetic Study of HDM1005 Injection at Different Injection Sites
A Phase 1 study testing HDM1005 in people with Overweight and/or Obesity and Healthy Participants, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the relative bioavailability of a single subcutaneous injection of HDM1005 solution at different injection sites (upper arm and thigh)by using the abdomen subcutaneous injection as a control. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and/or Obesity, Healthy Participants
- What is being tested?
- HDM1005
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2026to Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Aged between 18 and 55 years (inclusive), regardless of gender.
- Body weight ≥50.0 kg for males and ≥45.0 kg for females; body mass index (BMI) between 19.0 and 35.0 kg/m² (inclusive).
- In the investigator's opinion, the participants do not have any clinically significant abnormal findings based on medical history, clinical laboratory tests, vital signs, 12-lead ECG, and physical examination at screening.
- Provide signed informed consent before any trial procedures; fully understand the trial content, procedures, and possible adverse reactions.
Who cannot join
- Personal or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2).
- History of chronic pancreatitis, or an episode of acute pancreatitis within 3 months prior to screening.
- History of acute cholecystitis within 3 months prior to screening.
- Severe hypoglycemic events or recurrent hypoglycemic events (≥3 episodes per week) within 3 months prior to screening.
- Presence of clinically significant diseases involving any of the following systems at screening (including but not limited to respiratory, circulatory, digestive, hematopoietic, endocrine, immune, skin, nervous, psychiatric, ear-nose-throat, etc.), which in the investigator's opinion make the participant unsuitable.
- History of specific allergy (such as asthma, urticaria, eczema, etc.) or allergic constitution; or known intolerance or allergy to any component of the investigational drug or GLP-1 receptor (GLP-1R) agonists; or have a history of severe drug allergies.
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- Major surgery within 6 months prior to screening, or incomplete healing of surgical incisions, or planned surgery during the study.
- Blood donation or blood loss ≥400 mL, or use of blood products within 3 months prior to screening or between screening and dosing.
- History of drug abuse or positive urine drug test at screening.
- Use of prescription or over-the-counter medications, health supplements, or herbal medicines within 2 weeks prior to IMP administration, or still within 5 half-lives of such medications.
- Participation in any clinical trial and use of investigational product within 3 months prior to screening, or still within 5 half-lives of the investigational product from a previous trial at the time of screening (whichever is longer).
- Female participants who are breastfeeding or pregnant.
- History of needle phobia or hemophobia, difficulty with blood collection, or inability to tolerate venipuncture.
- Any other condition (medical, psychological, psychiatric, social, or geographic factors) that, in the investigator's opinion, makes the participant unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the relative bioavailability of a single subcutaneous injection of HDM1005 solution at different injection sites (upper arm and thigh)by using the abdomen subcutaneous injection as a control.
- Conditions
- Overweight and/or Obesity, Healthy Participants
- Being tested
- HDM1005
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDM1005Drug
2.0 mg, SC, single dose
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (Abdomen) | Experimental | Subject received a single subcutaneous injection of HDM1005 solution (0.5 mL, 2 mg) at abdomen. Receives: Drug: HDM1005 |
| Cohort 2 (Upper arm) | Experimental | Subject received a single subcutaneous injection of HDM1005 solution (0.5 mL, 2 mg) at upper arm. Receives: Drug: HDM1005 |
| Cohort 3 (Thigh) | Experimental | Subject received a single subcutaneous injection of HDM1005 solution (0.5 mL, 2 mg) at thigh. Receives: Drug: HDM1005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed concentration
Measured: Up to Day 29
AUC(0-t)
Area under the curve from time 0 to t hour
Measured: Up to Day 29
AUC(0-∞)
Area under the curve from time 0 hour to ∞
Measured: Up to Day 29
Secondary outcomes (5)
Tmax
Time to maximum plasma concentration
Measured: Up to Day 29
t1/2
Half life
Measured: Up to Day 29
CL/F
Apparent Clearance
Measured: Up to Day 29
Vz/F
Apparent volume of distribution
Measured: Up to Day 29
Adverse events (AEs)
Number of subjects reporting AEs
Measured: Up to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start3 Sep 2026
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and/or ObesityStudies 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
- 135 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828197
- Sponsor's protocol ID
- HDM1005-106
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Study of HDM1005 Injection at Different Injection Sites
- ClinicalTrials.gov ID
- NCT07828197
- Acronym / sponsor ID
- HDM1005-106
- Conditions
- Overweight and/or Obesity, Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Sep 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 18 Sep 2026 (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.
The purpose of this study is to evaluate the relative bioavailability of a single subcutaneous injection of HDM1005 solution at different injection sites (upper arm and thigh)by using the abdomen subcutaneous injection as a control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (Abdomen) | Experimental | Drug: HDM1005Subject received a single subcutaneous injection of HDM1005 solution (0.5 mL, 2 mg) at abdomen. |
| Cohort 2 (Upper arm) | Experimental | Drug: HDM1005Subject received a single subcutaneous injection of HDM1005 solution (0.5 mL, 2 mg) at upper arm. |
| Cohort 3 (Thigh) | Experimental | Drug: HDM1005Subject received a single subcutaneous injection of HDM1005 solution (0.5 mL, 2 mg) at thigh. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged between 18 and 55 years (inclusive), regardless of gender.
- Body weight ≥50.0 kg for males and ≥45.0 kg for females; body mass index (BMI) between 19.0 and 35.0 kg/m² (inclusive).
- In the investigator's opinion, the participants do not have any clinically significant abnormal findings based on medical history, clinical laboratory tests, vital signs, 12-lead ECG, and physical examination at screening.
- Provide signed informed consent before any trial procedures; fully understand the trial content, procedures, and possible adverse reactions.
Key exclusion criteria (14 listed)
- Personal or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2).
- History of chronic pancreatitis, or an episode of acute pancreatitis within 3 months prior to screening.
- History of acute cholecystitis within 3 months prior to screening.
- Severe hypoglycemic events or recurrent hypoglycemic events (≥3 episodes per week) within 3 months prior to screening.
- Presence of clinically significant diseases involving any of the following systems at screening (including but not limited to respiratory, circulatory, digestive, hematopoietic, endocrine, immune, skin, nervous, psychiatric, ear-nose-throat, etc.), which in the investigator's opinion make the participant unsuitable.
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 |
|---|---|---|
| HDM10052.0 mg, SC, single dose | Drug | Cohort 1 (Abdomen), Cohort 2 (Upper arm), Cohort 3 (Thigh) |
Primary outcome
Cmax
Time frame: Up to Day 29
Maximum observed concentration
AUC(0-t)
Time frame: Up to Day 29
Area under the curve from time 0 to t hour
AUC(0-∞)
Time frame: Up to Day 29
Area under the curve from time 0 hour to ∞
5 secondary outcomes
Tmax
Time frame: Up to Day 29
t1/2
Time frame: Up to Day 29
CL/F
Time frame: Up to Day 29
Vz/F
Time frame: Up to Day 29
Adverse events (AEs)
Time frame: Up to Day 29
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- 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.
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 HDM1005 in people with Overweight and/or Obesity and Healthy Participants, 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 4 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: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Cmax (time frame: Up to Day 29). 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 Oct 2026.