First human test of LP-005 drug completed in healthy volunteers
NCT ID NCT06294301
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested a new drug, LP-005, in 68 healthy adults aged 18 to 50. The main goal was to check if the drug is safe and how the body handles it. This information will help design future studies for people with a rare blood disorder called PNH.
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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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68 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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Aug 2024
- 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 50 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. Healthy males or females aged 18 through 50 years 2. Male subjects with a weight of ≥50 kg, female subjects with a weight of ≥45 kg, and BMI between 19.0 and 26.0 kg/m² (inclusive). 3. Vaccination: Meningococcal Conjugate Vaccine, Serogroups A, C, W, Y (MPV-ACYW) meningococcal conjugate vaccine and Streptococcus pneumoniae vaccine should be given 14 days or more before randomisation. 4. Male subjects and their partners or female subjects must agree to use one or more non-pharmaceutical contraceptive methods (such as total abstinence, condoms, Iuds, partner ligation, etc.) during the trial period and for 6 months after the trial, and do not plan to donate sperm or eggs. 5. The subjects fully understand the purpose, nature, method and possible adverse reactions of the experiment, and voluntarily participate in the experiment and sign the informed consent. 6. The subjects were able to communicate well with the researchers and complete the study according to the protocol. Exclusion Criteria: 1. Participants who are immunocompromised or have one of the following underlying diseases: anatomic absence of spleen (including sickle cell disease); congenital complement component deficiencies (complement component 3 and complement component 4). 2. Any history of Neisseria gonorrhea, meningitis infection, and Guillain-Barré syndrome. 3. Contraindications to meningococcal vaccination (previous medical history such as epilepsy or other brain disorders). 4. Presence or suspicion of active viral, bacterial, fungal, or parasitic infection, including herpes, shingles, or cold sores, within 14 days prior to screening. 5. History of unexplained recurrent infections, or use of systemic antibiotics within 90 days prior to dosing. 6. Malignancy or history of malignancy, except non-melanoma skin cancer cured for more than 3 years. 7. Positive HIV test (HIV-Ab), positive hepatitis B virus (HBV) test (HBsAg), positive hepatitis C virus (HCV), positive anti-syphilis helix-specific antibodies. 8. Participation in a clinical trial of any other drug within 3 months prior to screening or within 5 half-lives of other clinical trial drugs (selecting the longer time period). 9. Women who are pregnant, breastfeeding, or at risk of pregnancy. 10. Any condition deemed unsuitable for study participation by the investigator.
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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
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Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could a new pill tame a rare blood disease? early safety trial begins
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