- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05360927
Safety and Tolerability of BDB-001 Injection in Healthy Subjects
29. april 2022 oppdatert av: Staidson (Beijing) Biopharmaceuticals Co., Ltd
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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
28
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Beijing
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Beijing, Beijing, Kina, 100032
- Peking Union Medical College 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 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
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 0.3mg/kg
All participants (fasted) received either 0.3 mg/kg of BDB-001 as a single dose or dose-matched placebo.
|
Intravenous injection
Intravenøs injeksjon
|
Eksperimentell: Cohort 1mg/kg
All participants (fasted) received either 1 mg/kg of BDB-001 as a single dose or dose-matched placebo.
|
Intravenous injection
Intravenøs injeksjon
|
Eksperimentell: Cohort 3mg/kg
All participants (fasted) received either 3 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 8 mg/kg of BDB-001 as a single dose or dose-matched placebo.
|
Intravenous injection
Intravenøs injeksjon
|
Eksperimentell: Cohort 16mg/kg
All participants (fasted) received either 16 mg/kg of BDB-001 as a single dose or dose-matched placebo.
|
Intravenous injection
Intravenøs injeksjon
|
Eksperimentell: Cohort 20mg/kg
All participants (fasted) received either 20 mg/kg of BDB-001 as a single dose or dose-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 50 days
|
Up to 50 days
|
Maximum plasma concentration (Cmax)
Tidsramme: Up to 1200 hours postdose
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Up to 1200 hours postdose
|
Area under the plasma concentration-time curve from time 0 to infinity (AUC0inf)
Tidsramme: Up to 1200 hours postdose
|
Up to 1200 hours postdose
|
Area under the plasma concentration-time curve from time 0 to 1200hr(AUC00-1200hr)
Tidsramme: Up to 1200 hours postdose
|
Up to 1200 hours postdose
|
Time of maximum concentration (Tmax)
Tidsramme: Up to 1200 hours postdose
|
Up to 1200 hours postdose
|
Elimination half-life (t1/2)
Tidsramme: Up to 1200 hours postdose
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Up to 1200 hours postdose
|
Clearance (CL)
Tidsramme: Up to 1200 hours postdose
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Up to 1200 hours postdose
|
Apparent volume of distribution (Vz)
Tidsramme: Up to 1200 hours postdose
|
Up to 1200 hours postdose
|
Mean residence time (MRT)
Tidsramme: Up to 1200 hours postdose
|
Up to 1200 hours postdose
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Number of participants developing anti-BDB-001 antibodies
Tidsramme: Up to 50 days
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Up to 50 days
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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)
25. september 2019
Primær fullføring (Faktiske)
25. desember 2020
Studiet fullført (Faktiske)
25. desember 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-BDB001-01
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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