A Study of Single and Multiple Doses of LP-005 in Healthy Adult Participants

December 8, 2025 updated by: Longbio Pharma

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

The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-005 in healthy volunteers. The study will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human (FIH) study of LP-005 and Part 2, multiple ascending dose (MAD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Shanghai Public Health Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1: LP-005 Dose 1 (Single)
Biological: LP-005 Dose 1 (Single)
A single dose of LP-005 (Dose 1) was administered intravenously.
Experimental: Cohort 2: LP-005 Dose 2 (Single)
Biological: LP-005 Dose 2 (Single)
A single dose of LP-005 (Dose 2) was administered intravenously.
Experimental: Cohort 3: LP-005 Dose 3 (Single)
Biological: LP-005 Dose 3 (Single)
A single dose of LP-005 (Dose 3) was administered intravenously.
Experimental: Cohort 4: LP-005 Dose 4 (Single)
Biological: LP-005 Dose 4 (Single)
A single dose of LP-005 (Dose 4) was administered intravenously.
Experimental: Cohort 5: LP-005 Dose 5 (Single)
Biological: LP-005 Dose 5 (Single)
A single dose of LP-005 (Dose 5) was administered intravenously.
Experimental: Cohort 6: LP-005 Dose 6 (Single)
Biological: LP-005 Dose 6 (Single)
A single dose of LP-005 (Dose 6) was administered intravenously.
Placebo Comparator: Cohort 7: Placebo (Single)
Biological: Placebo (Single)
A single dose of placebo was administered intravenously.
Experimental: Cohort 8: LP-005 Dose 7 (Multiple)
Biological: LP-005 Dose 7 (Multiple)
LP-005 (Dose 7) was administered multiple times intravenously.
Experimental: Cohort 9: LP-005 Dose 8 (Multiple)
Biological: LP-005 Dose 8 (Multiple)
LP-005 (Dose 8) was administered multiple times intravenously.
Experimental: Cohort 10: LP-005 Dose 9 (Multiple)
Biological: LP-005 Dose 9 (Multiple)
LP-005 (Dose 9) was administered multiple times intravenously.
Placebo Comparator: Cohort 11: Placebo (Multiple)
Biological: Placebo (Multiple)
Placebo was administered multiple times intravenously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: Observation for 78 days after administration
Number of subjects with treatment-related Treatment Emergent Adverse Events (TEAEs).
Observation for 78 days after administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to peak concentration (Tmax) of LP-005
Time Frame: Observation for 78 days after administration
The time when the blood drug concentration reaches its peak after a single dose of medication.
Observation for 78 days after administration
Maximum concentration (Cmax) of LP-005
Time Frame: Observation for 78 days after administration
The maximum concentration of LP-005 in the bloodstream after administration.
Observation for 78 days after administration
Elimination half-life (t1/2) of LP-005
Time Frame: Observation for 78 days after administration
The time required for the concentration of LP-005 in the bloodstream to decrease by half.
Observation for 78 days after administration
Area under the concentration-time curve (AUC0-t) of LP-005
Time Frame: Observation for 78 days after administration
The area under the concentration-time curve (AUC) from time zero to the last chosen time point represents the integral of the drug concentration in the bloodstream over the specified duration.
Observation for 78 days after administration
Apparent clearance rate (CL/F) of LP-005
Time Frame: Observation for 78 days after administration
The ratio of drug clearance to drug concentration, represents the apparent clearance of a drug after administration, adjusted for bioavailability.
Observation for 78 days after administration
Assessment of immunogenicity
Time Frame: Observation for 78 days after administration
The proportion of anti drug antibody (ADA) positive subjects at different detection time points.
Observation for 78 days after administration
Assessment of complement C5 activity
Time Frame: Observation for 78 days after administration
Evaluate complement C5 hemolytic activity and serum concentration of C5 changes from baseline at various time points of assessment.
Observation for 78 days after administration
Assessment of complement C3b activity
Time Frame: Observation for 78 days after administration
Evaluate C3b deposition on red blood cells and serum concentration of C3b changes from baseline at various time points of assessment.
Observation for 78 days after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Longbio Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2023

Primary Completion (Actual)

August 31, 2024

Study Completion (Actual)

August 31, 2024

Study Registration Dates

First Submitted

February 3, 2024

First Submitted That Met QC Criteria

February 27, 2024

First Posted (Actual)

March 5, 2024

Study Record Updates

Last Update Posted (Estimated)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 8, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P10-LP005-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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