A Study of Single and Multiple Dose Administration of LP-001 in Healthy Subjects

Myelodysplastic Syndrome (MDS) Clinical Trial

Official title:

A Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetics of LP-001 Injection in Healthy Subjects Following Single and Multiple Doses

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06294275
• Other study ID #: P-10-LP001-2022-01
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: September 16, 2022
• Est. completion date: April 6, 2024

Study information

• Verified date: February 2024
• Source: Longbio Pharma
• Contact: n/a
• 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-001 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-001 and Part 2, multiple ascending dose (MAD).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 68
• Est. completion date: April 6, 2024
• Est. primary completion date: January 2, 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. Male subjects and their partners, or female subjects, must agree to use one or more non-pharmacological contraceptive measures during the trial and up to 6 months after the end of the trial (such as complete abstinence, condoms, intrauterine devices, partner sterilization, etc.), and should have no plans for sperm or egg donation.

4. The upper limits for hemoglobin (Hb) and hematocrit (HCT) are 165 g/L and 49%, respectively, for males, and 150 g/L and 45%, respectively, for females.

5. Subjects have a full understanding of the trial's purpose, nature, methods, and potential adverse reactions, voluntarily agree to participate in the trial, and sign the informed consent form.

6. Subjects can communicate effectively with the researchers and can comply with the study protocol as specified.

Exclusion Criteria:

1. Family history of early-onset coronary artery disease, including first- or second-degree relatives diagnosed with coronary heart disease or angina before the age of 50; any family history of hematological disorders, such as thrombosis or increased clotting risk, or any family history of deep vein thrombosis, pulmonary embolism, stroke, hemolytic anemia, or hemoglobinopathies; family history of hypertension. Alternatively, the subject has a personal medical history of the aforementioned conditions.

2. Presence of liver or kidney diseases or conditions affecting drug absorption, distribution, metabolism, or excretion, including other medical situations such as surgical procedures, trauma, etc. that may interfere with these processes.

3. Diagnosed with malignant tumors or having a history of malignant tumors, excluding non-melanoma skin cancer cured for more than 3 years.

4. HIV testing positive (HIV-Ab), hepatitis B virus (HBV) testing positive (HBsAg or HBcAb), hepatitis C virus (HCV) positive (HCV-RNA), and specific antibodies for syphilis positive, excluding positive results caused by immunization.

5. Abnormal vital signs (reference normal range: sitting systolic blood pressure 90-139 mmHg, diastolic blood pressure 60-89 mmHg, pulse rate 60-100 beats/min; body temperature 35.4-37.7°C) or abnormal electrocardiogram (QTcB=450 ms), or clinically significant abnormalities in physical examination, laboratory tests, and abdominal ultrasound (as judged by the clinical research doctor).

6. Clear history of drug allergy or specific hypersensitivity reactions (asthma, urticaria, allergic rhinitis, eczematous dermatitis); known allergies to the investigational drug and excipients, or allergies to similar drugs; individuals intolerant to subcutaneous injections or with a history of fainting during needle procedures.

7. Use of erythropoiesis-stimulating agents or treatment with other biologics within the six months prior to screening.

8. Participation in any other drug clinical trial within the 3 months prior to screening or within 5 half-lives of any investigational drug from other clinical trials (selecting the longer time period).

9. Pregnant or lactating women or women with the possibility of becoming pregnant.

10. Any condition deemed unsuitable for participation in the study by the investigator.

Related Conditions & MeSH terms

• Myelodysplastic Syndrome (MDS)
• Myelodysplastic Syndromes
• Preleukemia

Intervention

Biological:
• LP-001 Dose 1 (Single)
A single dose of LP-001 (Dose 1) was administered subcutaneously.
• LP-001 Dose 2 (Single)
A single dose of LP-001 (Dose 2) was administered subcutaneously.
• LP-001 Dose 3 (Single)
A single dose of LP-001 (Dose 3) was administered subcutaneously.
• LP-001 Dose 4 (Single)
A single dose of LP-001 (Dose 4) was administered subcutaneously.
• LP-001 Dose 5 (Single)
A single dose of LP-001 (Dose 5) was administered subcutaneously.
• LP-001 Dose 6 (Single)
A single dose of LP-001 (Dose 6) was administered subcutaneously.
• Placebo (Single)
A single dose of placebo was administered subcutaneously.
• LP-001 Dose 7 (Multiple)
LP-001 (Dose 7) was administered multiple times subcutaneously.
• LP-001 Dose 8 (Multiple)
LP-001 (Dose 8) was administered multiple times subcutaneously.
• Placebo (Multiple)
Placebo was administered multiple times subcutaneously.

Locations

Country	Name	City	State
China	Shanghai Public Health Clinical Center	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 36 days after administration
Secondary	Time to peak concentration (Tmax) of LP-001	The time when the blood drug concentration reaches its peak after a single dose of medication.	Observation for 36 days after administration
Secondary	Maximum concentration (Cmax) of LP-001	The maximum concentration of LP-001 in the bloodstream after administration.	Observation for 36 days after administration
Secondary	Elimination half-life (t1/2) of LP-001	The time required for the concentration of LP-005 in the bloodstream to decrease by half.	Observation for 36 days after administration
Secondary	Area under the concentration-time curve (AUC0-t) of LP-001	The time required for the concentration of LP-005 in the bloodstream to decrease by half.	Observation for 36 days after administration
Secondary	Apparent clearance rate (CL/F) of LP-001	The ratio of drug clearance to drug concentration, represents the apparent clearance of a drug after administration, adjusted for bioavailability.	Observation for 36 days after administration
Secondary	Assessment of immunogenicity	The proportion of anti drug antibody (ADA) positive subjects at different detection time points.	Observation for 36 days after administration
Secondary	Assessment of hemoglobin (Hb) change	Concentration of Hemoglobin changes from baseline at various time points of assessment.	Observation for 36 days after administration
Secondary	Assessment of red blood cell (RBC) count change	The count of RBC changes from baseline at various time points of assessment.	Observation for 36 days after administration
Secondary	Assessment of reticulocyte (Rtc) count change	The count of Rtc changes from baseline at various time points of assessment.	Observation for 36 days after administration