Evaluate the Pharmacokinetics of BAT2022 in Healthy Chinese Subjects

NCT05518695 | Completed Phase 1

• 1 other identifier: BAT-2022-001-CR
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and tolerability of BAT2022 in healthy subjects.

Conditions

SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

• Dose limiting toxicity (DLT)

  Grade ≥3 AEs in this criteria are defined as dose-limiting toxicity (DLT).

  DLT observation period is 7 days postdose.

Secondary Outcomes (1)

• Maximum tolerated dose (MTD)

  DLT observation period is 7 days postdose.

Study Arms (4)

A1/100mg

EXPERIMENTAL

Drug:BAT2022 for Intravenous fluids 100mg

Drug: BAT2022

A2/300mg

EXPERIMENTAL

Drug:BAT2022 for Intravenous fluids 300mg

Drug: BAT2022

A3/1000mg

EXPERIMENTAL

Drug:BAT2022 for Intravenous fluids 1000mg

Drug: BAT2022

A4/1500mg

EXPERIMENTAL

Drug:BAT2022 for Intravenous fluids 1500mg

Drug: BAT2022

Interventions

BAT2022 DRUG

Eight healthy subjects are planned to be enrolled in each group, 6 on the investigational product and 2 on placebo. Subjects will be randomized (3:1) to receive a single intravenous injection of BAT2022 for Injection or 5% glucose injection. Sentinel dosing will be performed for subjects in each group.Two subjects in each group who have received the first dose will be randomized (1:1) to either the test group or placebo group. After observation for 24 h and the drug is safe and well tolerated, the remaining subjects in this group will be randomized (5:1) to either the test group or placebo group.

Also known as: BAT2022 for Injection (bispecific neutralizing antibody targeting the receptor binding domain (RBD) of spike of SARS-CoV-2)

A1/100mg; A2/300mg; A3/1000mg; A4/1500mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects who have signed the informed consent form prior to the study and have a full understanding of the content, process and possible adverse reactions;
• Subjects who are willing and able to follow the visit and treatment specified in this study;
• Subject (including partner) who is willing to have no pregnancy plan or sperm donation plan within the following 6 months (i.e., within 6 months after administration of the investigational product) and voluntarily take effective contraceptive measures;
• Healthy male or female subjects aged 18 \~ 55 years (inclusive);
• Subjects with body weight of 50 kg \~ 100 kg (inclusive);
• Subjects with normal or abnormal physical examination without clinical significance;

You may not qualify if:

• Subjects who have smoked more than 5 cigarettes per day three months prior to Screening;
• Any subject with a current or past serious allergic reaction to food or drug, or serious allergic or allergic reaction to human, humanized or mouse monoclonal antibody;
• Subjects with a history of alcoholism (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of liquor, or 125 mL of wine);
• Subjects who have donated blood or had massive blood loss (\>450 mL) within three months prior to screening, or intend to donate blood or undergo surgery during the study;
• Subjects who have taken any prescription drug, over-the-counter drug, any vitamin products or herbal medicines 28 days prior to Screening;
• Subjects who have significant changes in diet or exercise habits 2 weeks prior to screening or from screening to administration;
• Subjects who have used any biological products within 3 months prior to screening;
• Subjects with clinical significance of abnormal heart assessed using Color Doppler echocardiography
• Subjects with clinical significance of abnormal laboratory findings (hematology, urinalysis, serum chemistry, coagulation function, virology of infectious diseases and pregnancy test for women of childbearing age), or other clinical findings suggestive of the following disorders with clinical relevance (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immune, psychiatric or cardiovascular and cerebrovascular diseases);
• Subjects with clinical significance of abnormal (as judged by the investigator) ECG, or QTcF \> 450 ms (allowed to be repeated for once);
• Subjects with acute illness or concomitant medication from screening to prior to administration of the investigational product;
• Subjects with positive urine drug screen, or subjects with a history of drug abuse or drug use in the past 5 years;
• Subjects who have taken any alcohol-containing products within 48 hours prior to administration of the investigational product, or who are unable to limit alcohol consumption as required during the course of the study;
• Subjects with current or previous malignant tumours;
• Subjects with a history of hypertension or systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg at screening/baseline;

Sponsors & Collaborators

• Bio-Thera Solutions: lead

Study Sites (1)

Union Hospital Tong Ji Medical College University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

BAT2022; Injections

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

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Weiyong Li

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-Blind
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 29, 2022
• Study Start: June 9, 2022
• Primary Completion: November 7, 2022
• Study Completion: November 7, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)