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CompletedNCT05518695Updated Nov 15, 2022

Evaluate the Pharmacokinetics of BAT2022 in Healthy Chinese Subjects

A Phase 1 interventional study of BAT2022 in SARS-CoV-2 Infection, sponsored by Bio-Thera Solutions. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2022-11-15.

Sponsored by Bio-Thera Solutions · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

Read the detailed description

This is a single-center, randomized, double-blind, placebo-controlled, dose-escalation clinical study to evaluate the pharmacokinetics, safety, tolerability, immunogenicity and pharmacodynamics of BAT2022 for Injection in healthy subjects.

02

Conditions studied

  • SARS-CoV-2 Infection

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 32 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Bio-Thera Solutions is the lead sponsor of 54 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

: Inclusion Criteria:

  1. 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;
  2. Subjects who are willing and able to follow the visit and treatment specified in this study;
  3. 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;
  4. Healthy male or female subjects aged 18 \~ 55 years (inclusive);
  5. Subjects with body weight of 50 kg \~ 100 kg (inclusive);
  6. Subjects with normal or abnormal physical examination without clinical significance;

Exclusion Criteria:

  1. Subjects who have smoked more than 5 cigarettes per day three months prior to Screening;
  2. 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;
  3. 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);
  4. 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;
  5. Subjects who have taken any prescription drug, over-the-counter drug, any vitamin products or herbal medicines 28 days prior to Screening;
  6. Subjects who have significant changes in diet or exercise habits 2 weeks prior to screening or from screening to administration;
  7. Subjects who have used any biological products within 3 months prior to screening;
  8. Subjects with clinical significance of abnormal heart assessed using Color Doppler echocardiography
  9. 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);
  10. Subjects with clinical significance of abnormal (as judged by the investigator) ECG, or QTcF > 450 ms (allowed to be repeated for once);
  11. Subjects with acute illness or concomitant medication from screening to prior to administration of the investigational product;
  12. Subjects with positive urine drug screen, or subjects with a history of drug abuse or drug use in the past 5 years;
  13. 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;
  14. Subjects with current or previous malignant tumours;
  15. Subjects with a history of hypertension or systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg at screening/baseline;
  16. Subjects with liver disorder who are judged by the investigator as inappropriate for enrollment;
  17. Subjects with abnormal focal shadows on chest radiograph, including but not limited to active pulmonary tuberculosis;
  18. Subjects who have participated in drug clinical study within three months prior to the first dose of the investigational product, or planned to participate in other drug clinical study during the study;
  19. Subjects who are considered by the investigator as inappropriate for enrollment.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    A1/100mg

    Drug:BAT2022 for Intravenous fluids 100mg

    Drug: BAT2022

  • Experimental
    A2/300mg

    Drug:BAT2022 for Intravenous fluids 300mg

    Drug: BAT2022

  • Experimental
    A3/1000mg

    Drug:BAT2022 for Intravenous fluids 1000mg

    Drug: BAT2022

  • Experimental
    A4/1500mg

    Drug:BAT2022 for Intravenous fluids 1500mg

    Drug: BAT2022

Interventions

  • DrugBAT2022

    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)

06

What researchers measure

Primary outcomes

  1. Dose limiting toxicity (DLT)

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

    Time frame: DLT observation period is 7 days postdose.

Secondary outcomes

  1. Maximum tolerated dose (MTD)

    it is determined that ≥ 50% of subjects have experienced a DLT as defined in this protocol

    Time frame: DLT observation period is 7 days postdose.

07

Study locations

1 site
  • Union Hospital Tong Ji Medical College University of Science and Technology
    Wuhan, Hubei 430030, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05518695
Lead sponsor
Bio-Thera Solutions
Responsible party
Sponsor
First posted
Aug 29, 2022
Start date
Jun 9, 2022
Primary completion
Nov 7, 2022
Completion
Nov 7, 2022
Last update
Nov 15, 2022

Study contacts

Weiyong Li
principal investigator · Wuhan Union Hospital, China

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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