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

Paroxysmal Nocturnal Hemoglobinuria (PNH) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06294301
• Other study ID #: P10-LP005-01
• Status: Recruiting
• Phase: Phase 1
• Start date: November 19, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: February 2024
• Source: Longbio Pharma
• Contact: Hongzhou Yang
• Phone: 021-58372390
• Email: yanghz[@]longbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: October 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemoglobinuria
• Hemoglobinuria, Paroxysmal
• Paroxysmal Nocturnal Hemoglobinuria (PNH)

Intervention

Biological:
• LP-005 Dose 1 (Single)
A single dose of LP-005 (Dose 1) was administered intravenously.
• LP-005 Dose 2 (Single)
A single dose of LP-005 (Dose 2) was administered intravenously.
• LP-005 Dose 3 (Single)
A single dose of LP-005 (Dose 3) was administered intravenously.
• LP-005 Dose 4 (Single)
A single dose of LP-005 (Dose 4) was administered intravenously.
• LP-005 Dose 5 (Single)
A single dose of LP-005 (Dose 5) was administered intravenously.
• LP-005 Dose 6 (Single)
A single dose of LP-005 (Dose 6) was administered intravenously.
• Placebo (Single)
A single dose of placebo was administered intravenously.
• LP-005 Dose 7 (Multiple)
LP-005 (Dose 7) was administered multiple times intravenously.
• LP-005 Dose 8 (Multiple)
LP-005 (Dose 8) was administered multiple times intravenously.
• LP-005 Dose 9 (Multiple)
LP-005 (Dose 9) was administered multiple times intravenously.
• Placebo (Multiple)
Placebo was administered multiple times intravenously.

Locations

Country	Name	City	State
China	Shanghai Public Health Clinical Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Longbio Pharma

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Number of subjects with treatment-related Treatment Emergent Adverse Events (TEAEs).	Observation for 78 days after administration
Secondary	Time to peak concentration (Tmax) of LP-005	The time when the blood drug concentration reaches its peak after a single dose of medication.	Observation for 78 days after administration
Secondary	Maximum concentration (Cmax) of LP-005	The maximum concentration of LP-005 in the bloodstream after administration.	Observation for 78 days after administration
Secondary	Elimination half-life (t1/2) of LP-005	The time required for the concentration of LP-005 in the bloodstream to decrease by half.	Observation for 78 days after administration
Secondary	Area under the concentration-time curve (AUC0-t) of LP-005	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
Secondary	Apparent clearance rate (CL/F) of LP-005	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
Secondary	Assessment of immunogenicity	The proportion of anti drug antibody (ADA) positive subjects at different detection time points.	Observation for 78 days after administration
Secondary	Assessment of complement C5 activity	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
Secondary	Assessment of complement C3b activity	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