Safety and Tolerability of BDB-001 Injection in Healthy Subjects

A Randomized, Double-blind,Placebo-controlled,Single-Ascending Dose Phase Ⅰ Study to Evaluate the Safety,Tolerability,and Pharmacokinetics of BDB-001 Injection in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BDB-001 injection; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100032
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 0.3mg/kg; All participants (fasted) received either 0.3 mg/kg of BDB-001 as a single dose or dose-matched placebo.	Drug: BDB-001 injection; Intravenous injection; Drug: Placebo; Intravenous injection
Experimental: Cohort 1mg/kg; All participants (fasted) received either 1 mg/kg of BDB-001 as a single dose or dose-matched placebo.	Drug: BDB-001 injection; Intravenous injection; Drug: Placebo; Intravenous injection
Experimental: Cohort 3mg/kg; All participants (fasted) received either 3 mg/kg of BDB-001 as a single dose or dose-matched placebo.	Drug: BDB-001 injection; Intravenous injection; Drug: Placebo; Intravenous injection
Experimental: Cohort 8mg/kg; All participants (fasted) received either 8 mg/kg of BDB-001 as a single dose or dose-matched placebo.	Drug: BDB-001 injection; Intravenous injection; Drug: Placebo; Intravenous injection
Experimental: Cohort 16mg/kg; All participants (fasted) received either 16 mg/kg of BDB-001 as a single dose or dose-matched placebo.	Drug: BDB-001 injection; Intravenous injection; Drug: Placebo; Intravenous injection
Experimental: Cohort 20mg/kg; All participants (fasted) received either 20 mg/kg of BDB-001 as a single dose or dose-matched placebo.	Drug: BDB-001 injection; Intravenous injection; Drug: Placebo; Intravenous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Adverse Events, Clinically Significant Laboratory Abnormalities, Clinically Significant Electrocardiogram Abnormalities, Clinically Significant Vital Signs Abnormalities And Clinically Significant Physical Examination Abnormalities	Up to 50 days
Maximum plasma concentration (Cmax)	Up to 1200 hours postdose
Area under the plasma concentration-time curve from time 0 to infinity (AUC0inf)	Up to 1200 hours postdose
Area under the plasma concentration-time curve from time 0 to 1200hr(AUC00-1200hr)	Up to 1200 hours postdose
Time of maximum concentration (Tmax)	Up to 1200 hours postdose
Elimination half-life (t1/2)	Up to 1200 hours postdose
Clearance (CL)	Up to 1200 hours postdose
Apparent volume of distribution (Vz)	Up to 1200 hours postdose
Mean residence time (MRT)	Up to 1200 hours postdose

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants developing anti-BDB-001 antibodies	Up to 50 days

Collaborators and Investigators

• Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd
• Collaborators: Beijing Defengrei Biotechnology Co.,Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2019
• Primary Completion (Actual): December 25, 2020
• Study Completion (Actual): December 25, 2020

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: April 29, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): May 4, 2022
• Last Update Submitted That Met QC Criteria: April 29, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: STS-BDB001-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No