- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05361005
Tolerability and Safety of BDB-001 Injection in Healthy Subjects
29 april 2022 uppdaterad av: Staidson (Beijing) Biopharmaceuticals Co., Ltd
A Phase Ic Single Center, Randomized, Double-Blind, Placebo-controlled, Single Dose Escalation and Multiple Dose Study to Evaluate the Tolerability and Pharmacokinetics of BDB-001 Injection in Healthy Subjects
A clinical study to evaluate the tolerability, PK and PD characteristics of BDB-001 Injection in healthy subjects.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
33
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Zhejiang
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Hangzhou, Zhejiang, Kina, 310022
- Shu Lan (Hangzhou) Hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 55 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Male or female subjects between 18~55 years old (including 18 and 55 years old);
- A healthy subject evaluated by medical history etc;
- Physical examination and vital signs normal, or abnormal without clinical significance;
- Weight: 80 kg ≥ male ≥50 kg, and 80 kg ≥ female ≥45 kg. Body Mass Index (BMI) between 18~28kg/m2 (including 18 and 28). Body mass index (BMI) = body weight (kg) / height 2 (m2);
- Be able to complete the study in compliance with protocol;
- The subjects (including sex partners) willing to take effective contraception measures within 6 months after the last dose. Refer to the appendix for the detailed contraceptive methods;
- Informed consent form signed prior to the study and the content, process and possible adverse reactions of the study fully understood.
Exclusion Criteria:
- More than 5 cigarettes were smoked daily within 3 months prior to screening period of the study;
- Allergic history (drugs and food);
- A history of drug abuse and / or drinking (drinking 14 units per week of alcohol: 1 unit = 285 mL beer, or liquor 25 mL, or wine 100ml);
- Subjects who had donated blood or massive blood loss (> 450 mL) within 3 months prior to screening period, or those who had plasma exchange within 4 weeks prior to screening period;
- Any prescription drugs, OTC drugs, any vitamin products or herbs were used within the 14 days prior to screening period, and immunomodulators were used within 28 days prior to screening period;
- Subjects who had taken other investigational product(s) or vaccine within 3 months prior to screening period, or those who were expected to be vaccinated within 2 months after completion of the study;
- Vigorous exercise or other factors affecting drug absorption, distribution, metabolism, excretion within 2 weeks prior to screening;
- Significant change in eating or exercise habits recently;
- Subjects who have taken BDB-001 injection or participated in clinical trials of investigational drugs within three months prior to taking study drugs;
- Subjects with a history of previous tuberculosis and exposure to active tuberculosis, TB-spot test results is greater than 2 UL(upper limit) of normal range, and those with infectious diseases recently;
- Subjects with autoimmune or immunodeficiency diseases, or with a family history of autoimmune diseases or immunodeficiency diseases;
- Abnormal ECG with clinical significance;
- Female subjects are in the lactation period or have positive serum pregnancy results during the period of trial (from screening to completion);
- Clinical laboratory examination result with clinical significance, or other clinical findings within 12 months prior to screening period with clinical significance ( including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular diseases);
- Subjects whose white blood cell count, high-sensitivity C-reactive protein test results were abnormal with clinical significance during screening and baseline period (-1 day), hemoglobin: male <120g/L or female <110g/L;
- Subjects with positive result of viral hepatitis (including hepatitis B and C), AIDS antibody, or treponema pallidum antibody;
- Subjects with acute disease or with concomitant medication from the screening stage to the start time of drug administration;
- Subjects with more than 5 cups (150mL cups) of coffee, tea or cola each day;
- Subjects with any alcohol-containing products within 48 hours before taking study medication;
- Subjects with a positive urine drug screening or with a history of drug abuse or drug use within the past five years;
- The investigators suggested the subject was not suitable to participate in this study.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Cohort 2mg/kg
All participants (fasted) received either 2 mg/kg of BDB-001 as a single dose or dose-matched placebo.
|
Intravenous injection
Intravenös injektion
|
Experimentell: Cohort 4mg/kg
All participants (fasted) received either 4 mg/kg of BDB-001 as a single dose or dose-matched placebo.
|
Intravenous injection
Intravenös injektion
|
Experimentell: Cohort 8mg/kg
All participants (fasted) received either 8mg/kg of BDB-001 as a single dose or dose-matched placebo.
|
Intravenous injection
Intravenös injektion
|
Experimentell: Cohort 4mg/kg multiple doses
All participants (fasted) received either 4 mg/kg of BDB-001 as a multiple doses or doses-matched placebo.
|
Intravenous injection
Intravenös injektion
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Incidence of Adverse Events, Clinically Significant Laboratory Abnormalities, Clinically Significant Electrocardiogram Abnormalities, Clinically Significant Vital Signs Abnormalities And Clinically Significant Physical Examination Abnormalities
Tidsram: Up to 28 Days
|
Up to 28 Days
|
Maximum plasma concentration (Cmax)
Tidsram: Up to 504 hours postdose
|
Up to 504 hours postdose
|
Area under the plasma concentration-time curve from time 0 to infinity (AUC0inf)
Tidsram: Up to 504 hours postdose
|
Up to 504 hours postdose
|
Area under the plasma concentration-time curve from time 0 to 480hr(AUC00-480hr)
Tidsram: Up to 504 hours postdose
|
Up to 504 hours postdose
|
Time of maximum concentration (Tmax)
Tidsram: Up to 504 hours postdose
|
Up to 504 hours postdose
|
Elimination half-life (t1/2)
Tidsram: Up to 504 hours postdose
|
Up to 504 hours postdose
|
Clearance (CL)
Tidsram: Up to 504 hours postdose
|
Up to 504 hours postdose
|
Apparent volume of distribution (Vz)
Tidsram: Up to 504 hours postdose
|
Up to 504 hours postdose
|
Mean residence time (MRT)
Tidsram: Up to 504 hours postdose
|
Up to 504 hours postdose
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Change from baseline in concentration of free C5a and anti-drug antibody
Tidsram: Up to 504 hours postdose
|
Up to 504 hours postdose
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
12 mars 2020
Primärt slutförande (Faktisk)
8 maj 2020
Avslutad studie (Faktisk)
8 maj 2020
Studieregistreringsdatum
Först inskickad
29 april 2022
Först inskickad som uppfyllde QC-kriterierna
29 april 2022
Första postat (Faktisk)
4 maj 2022
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
4 maj 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 april 2022
Senast verifierad
1 april 2022
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- STS-BDB001-05
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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