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

Longbio Pharma

Status and phase: Enrolling; Phase 1

Conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH)

Treatments: Biological: LP-005 Dose 4 (Single); Biological: LP-005 Dose 8 (Multiple); Biological: LP-005 Dose 6 (Single); Biological: Placebo (Single); Biological: LP-005 Dose 1 (Single); Biological: LP-005 Dose 5 (Single); Biological: LP-005 Dose 2 (Single); Biological: Placebo (Multiple); Biological: LP-005 Dose 9 (Multiple); Biological: LP-005 Dose 7 (Multiple); Biological: LP-005 Dose 3 (Single)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06294301

P10-LP005-01

Details and patient eligibility

About

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).

Enrollment: 78 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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78 participants in 11 patient groups, including a placebo group

Cohort 1: LP-005 Dose 1 (Single)

Experimental group

Treatment:

Biological: LP-005 Dose 1 (Single)

Cohort 2: LP-005 Dose 2 (Single)

Experimental group

Treatment:

Biological: LP-005 Dose 2 (Single)

Cohort 3: LP-005 Dose 3 (Single)

Experimental group

Treatment:

Biological: LP-005 Dose 3 (Single)

Cohort 4: LP-005 Dose 4 (Single)

Experimental group

Treatment:

Biological: LP-005 Dose 4 (Single)

Cohort 5: LP-005 Dose 5 (Single)

Experimental group

Treatment:

Biological: LP-005 Dose 5 (Single)

Cohort 6: LP-005 Dose 6 (Single)

Experimental group

Treatment:

Biological: LP-005 Dose 6 (Single)

Cohort 7: Placebo (Single)

Placebo Comparator group

Treatment:

Biological: Placebo (Single)

Cohort 8: LP-005 Dose 7 (Multiple)

Experimental group

Treatment:

Biological: LP-005 Dose 7 (Multiple)

Cohort 9: LP-005 Dose 8 (Multiple)

Experimental group

Treatment:

Biological: LP-005 Dose 8 (Multiple)

Cohort 10: LP-005 Dose 9 (Multiple)

Experimental group

Treatment:

Biological: LP-005 Dose 9 (Multiple)

Cohort 11: Placebo (Multiple)

Placebo Comparator group

Treatment:

Biological: Placebo (Multiple)