Healthy men test new drug copycat in early safety study
NCT ID NCT07495930
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study will test a new drug called HLX319 against an already approved drug, EU-Phesgo®, in 24 healthy Chinese men. The goal is to see how the body processes each drug and check for side effects. Participants receive a single injection and are monitored closely. This research helps decide if larger studies should move forward.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male subjects aged ≥18 and ≤45 years; 2. The skin at the injection site is intact, without damage, tattoos, or other markings; 3. Subjects have no history of disease or past medical history abnormalities that, in the judgment of the study physician, would affect the trial; 4. Physical examination, vital signs, chest x-ray, electrocardiogram, and laboratory investigations are normal or show abnormalities without clinical significance. 5. Body weight (BW) ≥50 and ≤75 kg; 6. Body mass index (BMI) ≥19 and ≤24 kg/m² \[BMI = weight (kg) / height² (m²)\]; 7. Within 14 days prior to random allocation, left ventricular ejection fraction (LVEF) assessed by echocardiography is within the normal range (≥55%); Exclusion Criteria: 1. Clinically significant diseases including but not limited to the gastrointestinal tract, kidneys, liver, nerves, blood, endocrine system, tumors, respiratory system, immune system, mental health, and cardiovascular and cerebrovascular diseases; 2. History of allergy or hypersensitivity reactions. 3. Intake of prescription drugs, over-the-counter drugs, or traditional Chinese medicine within 28 days prior to randomization; 4. History of blood donation or blood loss (\>450mL) within 3 months prior to randomization; 5. Positive test results for Hepatitis B Surface Antigen (HbsAg), Hepatitis C Virus (HCV) antibodies, and Human Immunodeficiency Virus (HIV) antibodies, or abnormal and clinically significant quantitative test results for syphilis spirochetes as determined by the sub investigator; 6. History of upper respiratory tract infection or other acute infections within 2 weeks prior to r randomization; 7. History of drug abuse, substance use; 8. History of alcoholism or positive alcohol test results; 11\. History of long-term heavy smoking .
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Anhui Medical University Second Affiliated Hospital
Hefei, Anhui, 230601, China
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