Clinical trial NCT04973735: A Phase I Study of LY-CovMab Injection in Chinese Healthy Subjects
Official title: A Phase I, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of LY-CovMab Injection in Chinese Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Covid19
Lead sponsor: Luye Pharma Group Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Shandong Boan Biotechnology Co., Ltd
First posted: 2021-07-22
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A single center, randomized, doubled-blind, placebo-control and single ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of LY-CovMab Injection in Chinese healthy subjects.

Detailed description: A single center, randomized, doubled-blind, placebo-control and single ascending dose phase I study:

Primary objective: to evaluate the safety and tolerability of a single dose of LY-CovMab Injection in Chinese healthy subjects.

Secondary objective: to evaluate the pharmacokinetics (PK) and immunogenicity of a single dose of LY-CovMab injection in Chinese healthy subjects.

Eligibility criteria: Inclusion Criteria:

A signed informed consent form (ICF) from the patient or their legally authorized representative.

Healthy males or females, ages ≥18 to ≤45 years. Male subjects with weight ≥50 kg, or female subjects with weight ≥45 kg, and body mass index (BMI) 19.0≤BMI≤26.0 kg/m2.

No abnormality, or no clinically significant abnormality in vital signs, physical examination, laboratory tests, and 12-lead ECG in Chinese healthy subjects during the screening period.

Female patients of childbearing potential (defined as female subjects who do not receive any operative sterilization or who had been through menopause for less than 1 year) must have a negative result for pregnancy test at screening. Male and female subjects with childbearing potential must agree to adopt effective contraceptive methods at least from 2 weeks prior to screening to 6 months after administration of the investigational drug.

Exclusion Criteria:

Those who have had surgery within 8 weeks prior to screening or who have surgery planned during the trial, and the investigator believes that such surgery may bring potential risks to the subjects.

Prior to administration of the investigational drug, use of the following drugs or therapies:

i. any prescription drug within 28 days. ii. any over-the-counter drug, including health care products within 7 days.

Prior history or current evidence of serious disease or chronic disease of the respiratory system, circulatory system, digestive system, urinary system, reproductive system, nervous system, immune system, hematology, psychiatry, and dermatology, etc, or any disease that may interfere with the trial results.

Subjects with coronavirus disease 2019 (COVID-19) or recovered from it or subjects positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid or serum SARS-CoV-2 specific antibodies.

Subjects who are with known history of allergies to any ingredient of the investigational drug, or similar drugs, or subjects with allergic constitution (previously sensitive to ≥ 2 foods or drugs).

Subjects with any positive test of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, treponema pallidum antibody, or human immunodeficiency virus (HIV) antibody.

Subjects with alcohol abuse or tobacco abuse, or alcohol blood test results exceeding the upper limit of the normal range. Alcohol abuse is defined as: alcohol consumption of more than 14 U (1 U = 350 mL of beer, or 45 mL of liquor, or 150 mL of wine) per week within 3 months prior to screening. Tobacco abuse is defined as: smoking ≥5 cigarettes per day on average within 3 months prior to screening.

Female subjects (including partners) who plan to be pregnant within one year upon screening, or pregnant or breast-feeding female subjects.

Subjects with a history of drug addiction or drug abuse, or with positive urine screen test results for drug.

Subjects donating whole blood or blood components, or with massive hemorrhage (\>400 mL), within 3 months prior to screening.

Prior vaccination with SARS-CoV-2 vaccine or participation in a SARS-CoV-2 neutralizing antibody clinical trial. Participation in any other clinical study with pharmacological intervention within 3 months prior to screening, or the drug is still within the elimination period (5 half-lives) prior to screening, whichever is longer. Vaccination within 12 weeks prior to screening, or planned vaccination during the study and within 12 weeks after the end of the study.

Subjects with a history of fainting at the sight of blood or puncture. Subjects who are not suitable to participate in the clinical trial as considered by the investigator or cannot complete the study for any other reasons.

Primary outcomes:
measure: Treatment-emergent Changes in Body Temperature
timeFrame: up to 99 days
measure: Treatment-emergent Changes in Respiratory Rate
timeFrame: up to 99 days
measure: Treatment-emergent Changes in Pulse Rate
timeFrame: up to 99 days
measure: Treatment-emergent Changes in Blood Pressure
timeFrame: up to 99 days
measure: Safety Laboratory Value (Haematology)
timeFrame: D-1, D4, D8, D15, D29, D50, D99
measure: Safety Laboratory Value (blood chemistry)
timeFrame: D-1, D4, D8, D15, D29, D50, D99
measure: Frequency and Grade of Adverse Events
timeFrame: up to 99 days
measure: Assess safety profile of LY-CovMab
timeFrame: D-1, D4, D8, D15, D29, D50, D99
measure: Assess safety profile of LY-CovMab
timeFrame: D-1, D4, D8, D15, D29, D50, D99
measure: Assess safety profile of LY-CovMab
timeFrame: D-1, D4, D8, D15, D29, D50, D99
measure: Assess safety profile of LY-CovMab
timeFrame: D-1, D4, D8, D15, D29, D50, D99
Secondary outcomes:
measure: Assess Pharmacokinetic parameters of LY-CovMab
timeFrame: up to 99 days
measure: Assess Pharmacokinetic parameters of LY-CovMab
timeFrame: up to 99 days
measure: Assess Pharmacokinetic parameters of LY-CovMab
timeFrame: up to 99 days
measure: Assess Pharmacokinetic parameters of LY-CovMab
timeFrame: up to 99 days
measure: Assess Pharmacokinetic parameters of LY-CovMab
timeFrame: up to 99 days
measure: Assess Pharmacokinetic parameters of LY-CovMab
timeFrame: up to 99 days
measure: Assess Pharmacokinetic parameters of LY-CovMab
timeFrame: up to 99 days
measure: Assess Pharmacokinetic parameters of LY-CovMab
timeFrame: up to 99 days
measure: Assess the immunogenicity of LY-CovMab
timeFrame: D1, D15, D29, D43, D57, D71, D99
measure: Assess the immunogenicity of LY-CovMab
timeFrame: D1, D15, D29, D43, D57, D71, D99
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
Study officials:
affiliation: The Second Hospital of Anhui Medical University
name: Hui Zhao, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Hospital of Anhui Medical University
name: Wei Hu, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang Q, Zhou R, Yang J, Dou C, Gan T, Liu F, Hu B, Song D, Lu C, Hu W. A Randomized, Double-Blind, Placebo-Controlled, First-in-Human Clinical Trial to Assess Safety, Tolerability, and Pharmacokinetics of LY-CovMab, a Potent Human Neutralizing Antibody Against SARS-CoV-2. Infect Dis Ther. 2022 Feb;11(1):405-422. doi: 10.1007/s40121-021-00572-x. Epub 2021 Dec 8.