Safety and Tolerability of BDB-001 Injection in Healthy Subjects

NCT ID: NCT05360927

Last Updated: 2022-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-25
• Study Completion Date: 2020-12-25

Brief Summary

A clinical study to evaluate the safety,tolerability,PK and PD characteristics of BDB-001 Injection in healthy subjects.

Conditions

Healthy

Study Design

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

Study Groups

Cohort 0.3mg/kg

All participants (fasted) received either 0.3 mg/kg of BDB-001 as a single dose or dose-matched placebo.

Group Type: EXPERIMENTAL

BDB-001 injection

Intervention Type: DRUG

Intravenous injection

Placebo

Intervention Type: DRUG

Intravenous injection

Cohort 1mg/kg

All participants (fasted) received either 1 mg/kg of BDB-001 as a single dose or dose-matched placebo.

Group Type: EXPERIMENTAL

BDB-001 injection

Intervention Type: DRUG

Intravenous injection

Placebo

Intervention Type: DRUG

Intravenous injection

Cohort 3mg/kg

All participants (fasted) received either 3 mg/kg of BDB-001 as a single dose or dose-matched placebo.

Group Type: EXPERIMENTAL

BDB-001 injection

Intervention Type: DRUG

Intravenous injection

Placebo

Intervention Type: DRUG

Intravenous injection

Cohort 8mg/kg

All participants (fasted) received either 8 mg/kg of BDB-001 as a single dose or dose-matched placebo.

Group Type: EXPERIMENTAL

BDB-001 injection

Intervention Type: DRUG

Intravenous injection

Placebo

Intervention Type: DRUG

Intravenous injection

Cohort 16mg/kg

All participants (fasted) received either 16 mg/kg of BDB-001 as a single dose or dose-matched placebo.

Group Type: EXPERIMENTAL

BDB-001 injection

Intervention Type: DRUG

Intravenous injection

Placebo

Intervention Type: DRUG

Intravenous injection

Cohort 20mg/kg

All participants (fasted) received either 20 mg/kg of BDB-001 as a single dose or dose-matched placebo.

Group Type: EXPERIMENTAL

BDB-001 injection

Intervention Type: DRUG

Intravenous injection

Placebo

Intervention Type: DRUG

Intravenous injection

Interventions

BDB-001 injection

Intravenous injection

Intervention Type: DRUG

Placebo

Intravenous injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Aged ≥ 18 but ≤ 65, male and female;
• Medical histories, physical examinations, laboratory examinations and study-related examinations and tests of the subjects，the Investigator judges that they are healthy;
• Body weight: 50- 80 kg, inclusive; Body mass index: 18.0 -26.0 kg/m2, inclusive;
• Vital signs: Blood pressure (90 mmHg≤ systolic ≤140 mmHg, 50 mmHg≤ diastolic ≤90 mmHg), heart rate (50≤ heart rate ≤100 beats/min), body temperature < 37°C;
• Subjects (including their partners) agree to take highly effective contraceptive measures during the study, and they have no birth plan or sperm donation plan within 6 months after the end of the study;
• Subjects are aware of the risks of the study, and voluntarily participate in the clinical study and sign an informed consent form (ICF).

Exclusion Criteria

• History of cardiovascular, respiratory, kidney, liver, metabolism, endocrine, gastrointestinal, blood, nerve, skin and mental illness, cancer or other major disease that in the judgment of the Investigator might put the subject as risk on this study;
• Past history of tuberculosis, history of contact with active tuberculosis, TB-SPOT test results exceeding the upper limit of 2 times or more, and recent infectious diseases;
• During the screening and baseline period, the white blood cell count and C-reactive protein test results are abnormal and have clinical significance, hemoglobin: male <120g/L or female <110g/L;
• Electrocardiogram (ECG) abnormalities and have clinical significance;
• Subjects who have an autoimmune disease or an immune deficiency disease, or a family history of an autoimmune disease or an immune deficiency disease;
• Subjects with clinically obvious allergic diseases;
• Positive screening test results for human immunodeficiency virus (HIV-1/HIV-2) antibodies, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab), treponema pallidum antibody;
• Participate in any drug or vaccine clinical trial as a subject within 3 months before screening or prepare to be vaccinated during the study period to 2 months after the end of the study;
• Have received any monoclonal antibody or biological agent treatment within the previous 3 months;
• Have taken drugs that may affect immune function within 6 months before screening or have taken prescription/over-the-counter drugs within the previous 14 days;
• Subjects who have donated either more than approximately 500 mL of blood within 3 months prior to screening or any plasma within 4 weeks prior to screening; Subjects who donated blood (>400 ml) within 3 months prior to screening, or plasma exchange within 4 weeks prior to screening;
• Drink more than 5 cups of coffee, tea or cola per day (150ml and above per cup);
• Subjects who test positive for alcohol or drugs during the screening;
• Subjects who smoke or smoke test results are positive;
• Subjects with poor compliance;
• Pregnant or lactating women;
• The investigator believes that there are any subjects who are not suitable to participate in this trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Defengrei Biotechnology Co.,Ltd

UNKNOWN

Sponsor Role: collaborator

Staidson (Beijing) Biopharmaceuticals Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

STS-BDB001-01

Identifier Type: -

Identifier Source: org_study_id