Clinical trial NCT06294301: A Study of Single and Multiple Doses of LP-005 in Healthy Adult Participants
Official title: To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Single and Multiple Doses of LP-005 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH)
Lead sponsor: Longbio Pharma
Sponsor class: INDUSTRY
First posted: 2024-03-05
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Adverse events
timeFrame: Observation for 78 days after administration
Secondary outcomes:
measure: Time to peak concentration (Tmax) of LP-005
timeFrame: Observation for 78 days after administration
measure: Maximum concentration (Cmax) of LP-005
timeFrame: Observation for 78 days after administration
measure: Elimination half-life (t1/2) of LP-005
timeFrame: Observation for 78 days after administration
measure: Area under the concentration-time curve (AUC0-t) of LP-005
timeFrame: Observation for 78 days after administration
measure: Apparent clearance rate (CL/F) of LP-005
timeFrame: Observation for 78 days after administration
measure: Assessment of immunogenicity
timeFrame: Observation for 78 days after administration
measure: Assessment of complement C5 activity
timeFrame: Observation for 78 days after administration
measure: Assessment of complement C3b activity
timeFrame: Observation for 78 days after administration
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
Study officials:
References: