NCT06294301

Completed

Phase 1

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

Longbio Pharma1 site in 1 country68 target enrollmentNovember 23, 2023

ConditionsParoxysmal Nocturnal Hemoglobinuria (PNH)

InterventionsLP-005 Dose 1 (Single)LP-005 Dose 2 (Single)LP-005 Dose 3 (Single)LP-005 Dose 4 (Single)LP-005 Dose 5 (Single)LP-005 Dose 6 (Single)Placebo (Single)LP-005 Dose 7 (Multiple)LP-005 Dose 8 (Multiple)LP-005 Dose 9 (Multiple)Placebo (Multiple)

Overview

Phase: Phase 1
Intervention: LP-005 Dose 1 (Single)
Conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH)
Sponsor: Longbio Pharma
Enrollment: 68
Locations: 1
Primary Endpoint: Adverse events
Status: Completed
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

November 23, 2023

End Date

August 31, 2024

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Longbio Pharma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy males or females aged 18 through 50 years
•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).
•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.
•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.
•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.
•The subjects were able to communicate well with the researchers and complete the study according to the protocol.

Exclusion Criteria

•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).
•Any history of Neisseria gonorrhea, meningitis infection, and Guillain-Barré syndrome.
•Contraindications to meningococcal vaccination (previous medical history such as epilepsy or other brain disorders).
•Presence or suspicion of active viral, bacterial, fungal, or parasitic infection, including herpes, shingles, or cold sores, within 14 days prior to screening.
•History of unexplained recurrent infections, or use of systemic antibiotics within 90 days prior to dosing.
•Malignancy or history of malignancy, except non-melanoma skin cancer cured for more than 3 years.
•Positive HIV test (HIV-Ab), positive hepatitis B virus (HBV) test (HBsAg), positive hepatitis C virus (HCV), positive anti-syphilis helix-specific antibodies.
•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).
•Women who are pregnant, breastfeeding, or at risk of pregnancy.
•Any condition deemed unsuitable for study participation by the investigator.

Arms & Interventions

Cohort 1: LP-005 Dose 1 (Single)

Intervention: LP-005 Dose 1 (Single)

Cohort 2: LP-005 Dose 2 (Single)

Intervention: LP-005 Dose 2 (Single)

Cohort 3: LP-005 Dose 3 (Single)

Intervention: LP-005 Dose 3 (Single)

Cohort 4: LP-005 Dose 4 (Single)

Intervention: LP-005 Dose 4 (Single)

Cohort 5: LP-005 Dose 5 (Single)

Intervention: LP-005 Dose 5 (Single)

Cohort 6: LP-005 Dose 6 (Single)

Intervention: LP-005 Dose 6 (Single)

Cohort 7: Placebo (Single)

Intervention: Placebo (Single)

Cohort 8: LP-005 Dose 7 (Multiple)

Intervention: LP-005 Dose 7 (Multiple)

Cohort 9: LP-005 Dose 8 (Multiple)

Intervention: LP-005 Dose 8 (Multiple)

Cohort 10: LP-005 Dose 9 (Multiple)

Intervention: LP-005 Dose 9 (Multiple)

Cohort 11: Placebo (Multiple)

Intervention: Placebo (Multiple)

Outcomes

Primary Outcomes

Adverse events

Time Frame: Observation for 78 days after administration

Number of subjects with treatment-related Treatment Emergent Adverse Events (TEAEs).

Secondary Outcomes

Assessment of complement C5 activity(Observation for 78 days after administration)
Maximum concentration (Cmax) of LP-005(Observation for 78 days after administration)
Elimination half-life (t1/2) of LP-005(Observation for 78 days after administration)
Assessment of complement C3b activity(Observation for 78 days after administration)
Apparent clearance rate (CL/F) of LP-005(Observation for 78 days after administration)
Area under the concentration-time curve (AUC0-t) of LP-005(Observation for 78 days after administration)
Time to peak concentration (Tmax) of LP-005(Observation for 78 days after administration)
Assessment of immunogenicity(Observation for 78 days after administration)