New drug HS-20152 tested in healthy people for first time
NCT ID NCT07503015
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests the safety of a new drug called HS-20152 in 32 healthy adults aged 18 to 64. The drug targets the complement system, part of the body's immune response. Researchers will monitor for side effects and measure how the drug moves through the body. This study does not aim to treat any disease.
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 32 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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Jul 2027
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 64 years
- Sex
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Anyone
- 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. Males or females aged 18 to 64 years (inclusive) when signing the ICF. 2. Body Mass Index (BMI = weight/height²) ≥ 19 kg/m² and ≤ 28 kg/m² at screening, and males must weigh ≥50 kg, and females must weigh ≥ 45 kg. 3. Female participants must agree to practice highly effective contraception from 2 weeks prior to screening until 6 months after dosing. 4. Male participants with childbearing potential must agree to practice highly effective contraception from the date of signing the ICF until 6 months after dosing; male participants without childbearing potential (e.g, having undergone effective sterilization) must agree to use additional highly effective contraception if there is any uncertainty about the presence of sperm. 5. Participants should be able to complete vaccinations against Neisseria meningitidis (types A, C, Y, and W-135) and streptococcus pneumoniae at least 2 weeks prior to the first dose. 6. The participants are able to communicate clearly with the investigator, understand and comply with the requirements of this study, have a comprehensive understanding of the study content, process and possible adverse reactions, and sign the ICF voluntarily. Exclusion Criteria: 1. Consumption of any caffeine, tea, alcohol, xanthine-rich foods or beverages within 24 hours before dosing. 2. Consumption of red wine, citrus fruits (such as grapefruit, oranges, tangerines, etc.), grapes, mangoes, or star fruits, or juices containing these fruits, within 72 hours prior to dosing. 3. Abnormal and clinically significant results in vital signs, physical examination, laboratory tests, 12-lead ECG, chest X-ray (anteroposterior and lateral)/CT, or abdominal ultrasound at screening, which, in the investigator's judgement, may increase the participant's risk in the study or affect the interpretation of the study results. 4. Positive for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), HCV Ab, HIV antibody, or syphilis-specific antibodies at screening. 5. Presence of non-active, active, or latent tuberculosis infection at screening (indicated by chest X-ray or CT showing tuberculosis lesions, or positive T-SPOT.TB results). 6. Positive pregnancy test at screening, or pregnant or breastfeeding at screening, or planning to become pregnant during the study. 7. Use of any medications, including prescription drugs, over-the-counter (OTC) drugs, herbal medicines, or dietary supplements, within 2 weeks prior to screening, or within 5 half-lives after the last dose of such medications, whichever is longer. 8. Receipt of any live attenuated vaccine within 30 days prior to dosing; receipt of any vaccine not specified in the protocol within 5 days prior to dosing; or planned receipt of any vaccine not specified in the protocol during the study. 9. Participation in other drug or medical device intervention clinical trials within 1 month prior to screening, and receipt of investigational drugs or use of medical devices, or being within 5 half-lives of the last dose of other investigational drugs, whichever is longer; or adverse events (AEs) from other trials that have not resolved to CTCAE Grade 1 or normal at screening. 10. Receipt of siRNA or antisense oligonucleotide therapy within 18 months prior to dosing. 11. Blood donation or blood loss of ≥ 450 mL (excluding menstruation) within 3 months prior to screening, or planned blood donation during the study. 12. Average smoking of \> 5 cigarettes per day within 3 months prior to screening. 13. Known history of drug abuse or drug use within 6 months prior to screening, or test positive for drug abuse at screening. 14. Known history of alcohol dependence (average consumption of ≥14 units per week, with each unit equivalent to 285 mL of beer, 125 mL of wine, or 25 mL of spirits) within 6 months prior to screening, or positive alcohol breath test at screening. 15. Undergone ≥ Grade 2 surgery within 6 months prior to screening, or plan to have surgery or hospitalization during the study. 16. History of severe allergies to medications, foods, or environmental factors, or known allergies to the active substances or excipients of the investigational product (including HS-20152 and placebo). 17. History of infection with encapsulated organisms (such as Neisseria meningitidis or Streptococcus pneumoniae), or close contact with individuals infected with Neisseria meningitidis. 18. Difficulty with blood draws, inability to tolerate multiple venous blood draws, or any contraindications to blood draws; or severe skin conditions that, in the investigator's judgement, make subcutaneous injection unsuitable. 19. Special dietary requirements or inability to comply with the dietary requirements of the study site. 20. As judged by the investigator, any prior or current disease or condition that may increase the risk to the participant from participating in the study, interfere with the participant's compliance with the protocol, or affect the participant's ability to complete the study.
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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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The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003, China
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