- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05361005
Tolerability and Safety of BDB-001 Injection in Healthy Subjects
29. april 2022 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
33
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Zhejiang
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Hangzhou, Zhejiang, Kina, 310022
- Shu Lan (Hangzhou) Hospital
-
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 55 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Cohort 2mg/kg
All participants (fasted) received either 2 mg/kg of BDB-001 as a single dose or dose-matched placebo.
|
Intravenous injection
Intravenøs injeksjon
|
Eksperimentell: Cohort 4mg/kg
All participants (fasted) received either 4 mg/kg of BDB-001 as a single dose or dose-matched placebo.
|
Intravenous injection
Intravenøs injeksjon
|
Eksperimentell: Cohort 8mg/kg
All participants (fasted) received either 8mg/kg of BDB-001 as a single dose or dose-matched placebo.
|
Intravenous injection
Intravenøs injeksjon
|
Eksperimentell: 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
Intravenøs injeksjon
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Incidence of Adverse Events, Clinically Significant Laboratory Abnormalities, Clinically Significant Electrocardiogram Abnormalities, Clinically Significant Vital Signs Abnormalities And Clinically Significant Physical Examination Abnormalities
Tidsramme: Up to 28 Days
|
Up to 28 Days
|
Maximum plasma concentration (Cmax)
Tidsramme: Up to 504 hours postdose
|
Up to 504 hours postdose
|
Area under the plasma concentration-time curve from time 0 to infinity (AUC0inf)
Tidsramme: Up to 504 hours postdose
|
Up to 504 hours postdose
|
Area under the plasma concentration-time curve from time 0 to 480hr(AUC00-480hr)
Tidsramme: Up to 504 hours postdose
|
Up to 504 hours postdose
|
Time of maximum concentration (Tmax)
Tidsramme: Up to 504 hours postdose
|
Up to 504 hours postdose
|
Elimination half-life (t1/2)
Tidsramme: Up to 504 hours postdose
|
Up to 504 hours postdose
|
Clearance (CL)
Tidsramme: Up to 504 hours postdose
|
Up to 504 hours postdose
|
Apparent volume of distribution (Vz)
Tidsramme: Up to 504 hours postdose
|
Up to 504 hours postdose
|
Mean residence time (MRT)
Tidsramme: Up to 504 hours postdose
|
Up to 504 hours postdose
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change from baseline in concentration of free C5a and anti-drug antibody
Tidsramme: Up to 504 hours postdose
|
Up to 504 hours postdose
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
12. mars 2020
Primær fullføring (Faktiske)
8. mai 2020
Studiet fullført (Faktiske)
8. mai 2020
Datoer for studieregistrering
Først innsendt
29. april 2022
Først innsendt som oppfylte QC-kriteriene
29. april 2022
Først lagt ut (Faktiske)
4. mai 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. mai 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. april 2022
Sist bekreftet
1. april 2022
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- STS-BDB001-05
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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