Testing LP-005 in healthy adults

To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Single and Multiple Doses of LP-005 in Healthy Volunteers

This study is testing a new drug called LP-005 in healthy adults to see how safe it is and how it affects their bodies at different dose levels.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Longbio Pharma (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06294301 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-005 in healthy adult participants. It consists of two parts: the first part involves single ascending doses (SAD) to assess the drug's effects in humans for the first time, while the second part involves multiple ascending doses (MAD). Healthy volunteers aged 18 to 50 will be monitored for their responses to the drug across different dose levels.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy males and females aged 18 to 50 who meet specific weight and BMI criteria.

Not a fit: Patients with existing health conditions or those outside the specified age and weight range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a better understanding of LP-005's safety and efficacy, potentially paving the way for new treatments for conditions like Paroxysmal Nocturnal Hemoglobinuria.

How similar studies have performed: While this study is focused on a novel drug, similar studies evaluating safety and dosing in healthy volunteers have shown success in the past.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai

• Shanghai Public Health Clinical Center — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Hongzhou Yang

Conditions Paroxysmal Nocturnal Hemoglobinuria