A Phase I Study of LY-CovMab Injection in Chinese Healthy Subjects

NCT ID: NCT04973735

Last Updated: 2021-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-10
• Study Completion Date: 2021-07-31

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

30mg LY-CovMab

LY-CovMab is diluted with 0.9% sodium chloride to a total volume of 250 mL for IV infusion

Group Type: EXPERIMENTAL

LY-CovMab

Intervention Type: DRUG

single IV infusion

150mg LY-CovMab

LY-CovMab is diluted with 0.9% sodium chloride to a total volume of 250 mL for IV infusion

Group Type: EXPERIMENTAL

LY-CovMab

Intervention Type: DRUG

single IV infusion

600mg LY-CovMab

LY-CovMab is diluted with 0.9% sodium chloride to a total volume of 250 mL for IV infusion

Group Type: EXPERIMENTAL

LY-CovMab

Intervention Type: DRUG

single IV infusion

1200mg LY-CovMab

LY-CovMab is diluted with 0.9% sodium chloride to a total volume of 250 mL for IV infusion

Group Type: EXPERIMENTAL

LY-CovMab

Intervention Type: DRUG

single IV infusion

2400mg LY-CovMab

LY-CovMab is diluted with 0.9% sodium chloride to a total volume of 250 mL for IV infusion

Group Type: EXPERIMENTAL

LY-CovMab

Intervention Type: DRUG

single IV infusion

Placebo

Placebo is diluted with 0.9% sodium chloride to a total volume of 250 mL for IV infusion

Group Type: PLACEBO_COMPARATOR

LY-CovMab

Intervention Type: DRUG

single IV infusion

Interventions

LY-CovMab

single IV infusion

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shandong Boan Biotechnology Co., Ltd

INDUSTRY

Sponsor Role: collaborator

Luye Pharma Group Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hui Zhao, Dr

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Anhui Medical University

Wei Hu, Dr

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Anhui Medical University

Locations

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 34878625 (View on PubMed)

Other Identifiers

LY-CovMab/CT-CHN-101

Identifier Type: -

Identifier Source: org_study_id