New HIV drug LP-98 tested in humans for first time
NCT ID NCT05933824
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This first-in-human study tested a single dose of LP-98 injection in 36 healthy adults to see if it is safe and how the body processes it. Participants received either LP-98 or a placebo by injection under the skin or into a vein. The study is complete, but it only looked at safety and immune response, not whether LP-98 can prevent or treat HIV.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LP-98 injection
- What this could lead to
- If successful, this early research could pave the way for a new HIV prevention or treatment option.
- What could go wrong
- This is a very early, small trial in healthy people, not those with HIV. It only checks safety and dosing, not whether LP-98 works against the virus. Many early-stage drugs fail to show benefit later.
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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
36 people
The number who actually took part.
- Started
-
Jul 2023
- Finished
-
Apr 2024
- Lead sponsor
-
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
-
18 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
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: Subjects must meet all of the following inclusion criteria for study entry: 1. Willing to participate in the study and sign ICF with clear date; 2. Aged 18 to 55 years at the screening visit, male or female; 3. Body weight ≥ 50 kg for males or body weight ≥ 45 kg for females, and body mass index (BMI) within the range of 19 to 28 kg/m2 (inclusive); 4. Be in good health in the PI's judgment, with no clinical significance in previous medical history, laboratory tests, physical examinations, vital signs, and ECG findings; 5. All subjects and his/her partners must agree to use effective non-drug contraception (except for subjects had permanent contraception, i.e., bilateral tubal ligation or vasectomy, etc.) from 2 weeks prior to screening to 3 months after finishing the study. Females must have a negative serum human chorionic gonadotropin (hCG) test for pregnancy confirmation at screening; 6. Willing to comply with the visits, treatments, laboratory tests and other study process required by the protocol. Exclusion Criteria: 1. Allergic to the IP or its excipients, or medicine of the same class , or having a history of severe allergies (including any food allergy or drug allergy); 2. With history or family history of psychiatric, or history of chronic or serious disorders of the central nervous system, cardiovascular, hepatic, nephrological, pulmanory, digestive, metabolic, hematological or skeletal system etc., or definitive history of myelosuppression, orany other significant history of disease that may affect the safety or PK parameters in the PI's judgment; 3. Having positive result for human immunodeficiency virus antibody (HIV-Ab), hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), or Treponema pallidum antibody; 4. Having clinically significant abnormal results of vital signs or laboratory tests required by the protocol; 5. Having clinically significant abnormality of 12-lead ECG, or having a QTcF interval (using Fridericia's correction) \> 450 ms for males or \> 470 ms for females; 6. With serum creatine clearance rate (Ccr) \< 80 ml/min/1.73 m2 (based on Cockcroft-Gault formula); 7. Known or suspected history of drug abuse (i.e., morphine, methamphetamine, ketamine, dimethylenedioxymethamphetamine, tetrahydrocannabinol acid, cocaine etc.), or having positive result for drug abuse; 8. With history of heavy alcohol consumption within 1 year prior to screening (more than 21 units of alcohol per week, i.e., 360 ml of 5% beer, 45 ml of 40% hard liquor, 120 ml of 12% wine, or positive alcohol test; 9. Smoking more than 5 cigarettes per day within 3 months prior to screening, or inability to comply with the prohibition of smoking during the study; 10. Consuming amount \> 6 servings of coffee, tea, cola, energy-drink, or other caffeine-containing product per day. One serving ≈ 120 mg of caffeine. Or consumed any caffeine-containing product within 24 hours prior to the dosing of the IP; 11. Had received vaccination within 30 days prior to screening, or planning to receive vaccination during the study; 12. Had received any prescription and non-prescription drugs, herbal remedies, or dietary supplements within 14 days prior to the dosing of the IP; 13. Participated in any other clinical trial within 3 months prior to screening; 14. Had received surgical operation within 3 months prior to screening, or planning to receive surgical operation during the study; 15. Currently pregnant or lactating women; 16. Had blood donation or blood loss over 200 mL within 3 months prior to screening, or planning to donate blood during the study; 17. Cannot tolerate venipuncture blood collection and/or have a history of blood or needle sickness 18. Other conditions considered to be ineligible for study entry in the PI's judgment
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Henan Provincial Hospital for Infectious Diseases (Zhengzhou Sixth People's Hospital)
Zhengzhou, Henan, 450000, China
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