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New HIV drug LP-98 tested in humans for first time

NCT ID NCT05933824

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.