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

NCT04973735 | Unknown Phase 1

• 1 other identifier: LY-CovMab/CT-CHN-101
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (11)

• Treatment-emergent Changes in Body Temperature

  Grade of treatment-emergent changes in body temperature by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0. The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).

  up to 99 days

• Treatment-emergent Changes in Respiratory Rate

  Grade of treatment-emergent changes in respiratory rate by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0. The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).

  up to 99 days

• Treatment-emergent Changes in Pulse Rate

  Grade of treatment-emergent changes in pulse rate by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0. The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).

  up to 99 days

• Treatment-emergent Changes in Blood Pressure

  Grade of treatment-emergent changes in blood pressure by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0. The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).

  up to 99 days

• Safety Laboratory Value (Haematology)

  Haematology laboratory value by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0 (absolute and change from baseline where identified). The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).

  D-1, D4, D8, D15, D29, D50, D99

• Safety Laboratory Value (blood chemistry)

  Serum Chemistry laboratory value by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0 (absolute and change from baseline where identified). The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).

  D-1, D4, D8, D15, D29, D50, D99

• Frequency and Grade of Adverse Events

  up to 99 days

• Assess safety profile of LY-CovMab

  12 lead electrocardiogram (ECG) heart rate

  D-1, D4, D8, D15, D29, D50, D99

• Assess safety profile of LY-CovMab

  12 lead electrocardiogram (ECG) PR interval

  D-1, D4, D8, D15, D29, D50, D99

• Assess safety profile of LY-CovMab

  12 lead electrocardiogram (ECG) QTc interval

  D-1, D4, D8, D15, D29, D50, D99

• Assess safety profile of LY-CovMab

  12 lead electrocardiogram (ECG) QRS interval

  D-1, D4, D8, D15, D29, D50, D99

Secondary Outcomes (10)

• Assess Pharmacokinetic parameters of LY-CovMab

  up to 99 days

• Assess Pharmacokinetic parameters of LY-CovMab

  up to 99 days

• Assess Pharmacokinetic parameters of LY-CovMab

  up to 99 days

• Assess Pharmacokinetic parameters of LY-CovMab

  up to 99 days

• Assess Pharmacokinetic parameters of LY-CovMab

  up to 99 days

Study Arms (6)

30mg LY-CovMab

EXPERIMENTAL

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

Drug: LY-CovMab

150mg LY-CovMab

EXPERIMENTAL

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

Drug: LY-CovMab

600mg LY-CovMab

EXPERIMENTAL

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

Drug: LY-CovMab

1200mg LY-CovMab

EXPERIMENTAL

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

Drug: LY-CovMab

2400mg LY-CovMab

EXPERIMENTAL

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

Drug: LY-CovMab

Placebo

PLACEBO COMPARATOR

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

Drug: LY-CovMab

Interventions

LY-CovMab DRUG

single IV infusion

1200mg LY-CovMab; 150mg LY-CovMab; 2400mg LY-CovMab; 30mg LY-CovMab; 600mg LY-CovMab; Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead
• Shandong Boan Biotechnology Co., Ltd: collaborator

Study Sites (1)

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Location

Related Publications (1)

• 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.

  PMID: 34878625 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hui Zhao, Dr

  The Second Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

• Wei Hu, Dr

  The Second Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 22, 2021
• Study Start: November 10, 2020
• Primary Completion: May 1, 2021
• Study Completion: July 31, 2021
• Last Updated: July 22, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)