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Evaluate Safety and Pharmacokinetics of HLX70 in Healthy Adult Volunteers

20. Juni 2022 aktualisiert von: Shanghai Henlius Biotech

A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Phase I Clinical Study to Evaluate Safety and Pharmacokinetics of HLX70 in Healthy Adult Volunteers

A single-center, randomized, double-blind, placebo-controlled, dose escalation, phase I clinical study to evaluate safety and pharmacokinetics of HLX70 in healthy adult volunteers

Studienübersicht

Status

Zurückgezogen

Bedingungen

Detaillierte Beschreibung

A randomized, double-blind, single-dose by intravenous administration, placebo-controlled, dose escalation, first-in-human study is proposed to evaluate the safety, PK, and immunogenicity of HLX70 in healthy subjects. We plan to enroll 8 subjects in each of the 3 dose cohorts at 3 mg/kg, 10 mg/kg, and 30 mg/kg, of which 2 receive intravenous injections of placebo and 6 receive intravenous injections of the investigational product (IP). A total of 24 subjects will be enrolled.

Studientyp

Interventionell

Phase

  • Phase 1

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 60 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  1. Subjects with voluntary signing of the informed consent form (ICF);
  2. Healthy males or females aged ≥ 18 and ≤ 60 years at the time of signing the ICF;
  3. Subjects with body weight ≥ 50 kg and body mass index (BMI) must be higher than 18.5 kg/m2 and lower than 30 kg/m2 at screening visit ;
  4. Subjects who are determined to be in good health according to medical history, normal (site normal ranges to be followed) or abnormal but clinically insignificant physical examination, vital signs, ECG, laboratory test results (including hematology, serum chemistry, coagulation function, urinalysis, etc.), and investigator's clinical judgment (CTCAE grade 1 of triglycerides and uric acid is permitted). One re-test allowed per investigator discretion to confim result.
  5. Subject who agrees that he and his spouse or partner will use reliable contraception for 9 months after administration.

Exclusion Criteria:

  1. Subjects with the lab-confirmed medical history of COVID-19, including nucleic acid (PCR testing of nasopharyngeal samples) tested positive or antibody IgG/IgM tested positive.
  2. Subjects with the novel onset of pyrexia/cough/shortness of breath/diarrhea or history of contact with confirmed COVID-19 individuals (positive for SARS-CoV-2 nucleic acid) within the 14 days before randomization.
  3. Subjects who are known to have chronic obstructive pulmonary disease (COPD), cirrhosis of liver, cardiac failure or any condition that requires active medical intervention or monitoring to avert serious danger to the participant's health or well-being.
  4. Subjects with pneumonia or tuberculosis (TB) suggested by chest X-Ray.
  5. Subjects with previous exposure to a mAb or any other biological agents in 6 months before screening.
  6. Subjects with previous exposure to vaccines in 3 months before screening, or who plans to receive vaccination during the study period or in 3 months after the study.
  7. Subjects with previous participation in clinical trials receiving investigational drug/comparator within the longer of 30 days or 5 half-lives before screening.
  8. Subjects who are known to have a history of allergy to any mAb, biological product, protein product, or the ingredient of the IP.
  9. Subjects with positive test result(s) for hepatitis B virus (positive for HBsAg or positive for HBcAb and HBV-DNA), hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV) antibodies, or treponema pallidum.
  10. Subjects who are known to have a history of psychotropic drug abuse, alcoholism, or drug addiction within the last year.
  11. Subjects with a history of a blood donation within 3 months before screening.
  12. Subjects with the use of any prescription drug, OTC drug, or traditional Chinese medicine in 14 days before screening.
  13. Females who are pregnant or breastfeeding
  14. Other factors that the Investigator deems inappropriate for participation in the study.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Sequenzielle Zuweisung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: HLX70 3 mg/kg or Placebo
Random allocation to HLX70 3 mg/kg (IV, single dose), or placebo (IV, single dose) of which 2 receive intravenous injections of placebo and 6 receive intravenous injections of the HLX70.
Einzeldosis, intravenöse Infusion
Andere Namen:
  • Rekombinanter humanisierter monoklonaler Anti-S-Protein-Antikörper zur Injektion
Single-dose, intravenous infusion
Experimental: HLX70 10 mg/kg or Placebo
Random allocation to HLX70 10 mg/kg (IV, single dose), or placebo (IV, single dose) of which 2 receive intravenous injections of placebo and 6 receive intravenous injections of the HLX70.
Einzeldosis, intravenöse Infusion
Andere Namen:
  • Rekombinanter humanisierter monoklonaler Anti-S-Protein-Antikörper zur Injektion
Single-dose, intravenous infusion
Experimental: HLX70 30 mg/kg or Placebo
Random allocation to HLX70 30 mg/kg (IV, single dose), or placebo (IV, single dose) of which 2 receive intravenous injections of placebo and 6 receive intravenous injections of the HLX70.
Einzeldosis, intravenöse Infusion
Andere Namen:
  • Rekombinanter humanisierter monoklonaler Anti-S-Protein-Antikörper zur Injektion
Single-dose, intravenous infusion

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of participants with adverse events, serious adverse event and infusion-related reactions as assessed by CTCAE v5.0
Zeitfenster: up to 92 days.
Safety follow-up: All subjects in the study will undergo safety follow-up within 92 days after administration and receive routine laboratory tests on day 2, day 3, day 8, day 15, day 22 and day 29 post administration (see the study procedures for details). A telephone follow-up will be followed every week until day 92 (day 1 is defined as the day of IP infusion). For a subject suffering AE during the observation period, follow-up shall be continued until the AE returns to the baseline or it is stable from getting worse.
up to 92 days.
Safety evaluation- proportion of subjects undergoing DLT events
Zeitfenster: Days 1 to 7.
The proportion of subjects undergoing DLT events
Days 1 to 7.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
PK parameters-Areas under the concentration-time curves
Zeitfenster: pre-infusion (pre-dose), immediately post-infusion, 3 hours, 6 hours and 10 hours post-infusion, Days 2, 3, 5, 8, 11, 15, 22, 29, 43, 57, 71 and 92.
PK blood sampling points: All subjects in the study will participate in the PK study. PK blood sampling timepoints: pre-infusion, immediately post-infusion, and 3 h, 6 h, 10 h, 24 h(Day 2), 48 h (day 3) , 96 h (day 5), 168 h (day 8) , 240h (day 11) , 336 h (day 15), 504 h (day 22) , 672 (day 29) , 1008 h (day 43) ,1344 h (day 57), 1680 h (day 71) , and 2184 h (day 92), after HLX70 infusion. There are a total of 17 blood sampling time points.
pre-infusion (pre-dose), immediately post-infusion, 3 hours, 6 hours and 10 hours post-infusion, Days 2, 3, 5, 8, 11, 15, 22, 29, 43, 57, 71 and 92.
PK parameters-Maximum measured concentration
Zeitfenster: pre-infusion (pre-dose), immediately post-infusion, 3 hours, 6 hours and 10 hours post-infusion, Days 2, 3, 5, 8, 11, 15, 22, 29, 43, 57, 71 and 92.
PK blood sampling points: All subjects in the study will participate in the PK study. PK blood sampling timepoints: pre-infusion, immediately post-infusion, and 3 h, 6 h, 10 h, 24 h(Day 2), 48 h (day 3) , 96 h (day 5), 168 h (day 8) , 240h (day 11) , 336 h (day 15), 504 h (day 22) , 672 (day 29) , 1008 h (day 43) ,1344 h (day 57), 1680 h (day 71) , and 2184 h (day 92), after HLX70 infusion. There are a total of 17 blood sampling time points.
pre-infusion (pre-dose), immediately post-infusion, 3 hours, 6 hours and 10 hours post-infusion, Days 2, 3, 5, 8, 11, 15, 22, 29, 43, 57, 71 and 92.
PK parameters-Time from dosing to maximum measured concentration
Zeitfenster: pre-infusion (pre-dose), immediately post-infusion, 3 hours, 6 hours and 10 hours post-infusion, Days 2, 3, 5, 8, 11, 15, 22, 29, 43, 57, 71 and 92.
PK blood sampling points: All subjects in the study will participate in the PK study. PK blood sampling timepoints: pre-infusion, immediately post-infusion, and 3 h, 6 h, 10 h, 24 h(Day 2), 48 h (day 3) , 96 h (day 5), 168 h (day 8) , 240h (day 11) , 336 h (day 15), 504 h (day 22) , 672 (day 29) , 1008 h (day 43) ,1344 h (day 57), 1680 h (day 71) , and 2184 h (day 92), after HLX70 infusion. There are a total of 17 blood sampling time points.
pre-infusion (pre-dose), immediately post-infusion, 3 hours, 6 hours and 10 hours post-infusion, Days 2, 3, 5, 8, 11, 15, 22, 29, 43, 57, 71 and 92.
PK parameters-Terminal phase elimination rate constant
Zeitfenster: pre-infusion (pre-dose), immediately post-infusion, 3 hours, 6 hours and 10 hours post-infusion, Days 2, 3, 5, 8, 11, 15, 22, 29, 43, 57, 71 and 92.
PK blood sampling points: All subjects in the study will participate in the PK study. PK blood sampling timepoints: pre-infusion, immediately post-infusion, and 3 h, 6 h, 10 h, 24 h(Day 2), 48 h (day 3) , 96 h (day 5), 168 h (day 8) , 240h (day 11) , 336 h (day 15), 504 h (day 22) , 672 (day 29) , 1008 h (day 43) ,1344 h (day 57), 1680 h (day 71) , and 2184 h (day 92), after HLX70 infusion. There are a total of 17 blood sampling time points.
pre-infusion (pre-dose), immediately post-infusion, 3 hours, 6 hours and 10 hours post-infusion, Days 2, 3, 5, 8, 11, 15, 22, 29, 43, 57, 71 and 92.
PK parameters-Terminal phase elimination half life
Zeitfenster: pre-infusion (pre-dose), immediately post-infusion, 3 hours, 6 hours and 10 hours post-infusion, Days 2, 3, 5, 8, 11, 15, 22, 29, 43, 57, 71 and 92.
PK blood sampling points: All subjects in the study will participate in the PK study. PK blood sampling timepoints: pre-infusion, immediately post-infusion, and 3 h, 6 h, 10 h, 24 h(Day 2), 48 h (day 3) , 96 h (day 5), 168 h (day 8) , 240h (day 11) , 336 h (day 15), 504 h (day 22) , 672 (day 29) , 1008 h (day 43) ,1344 h (day 57), 1680 h (day 71) , and 2184 h (day 92), after HLX70 infusion. There are a total of 17 blood sampling time points.
pre-infusion (pre-dose), immediately post-infusion, 3 hours, 6 hours and 10 hours post-infusion, Days 2, 3, 5, 8, 11, 15, 22, 29, 43, 57, 71 and 92.
PK parameters-Clearance
Zeitfenster: pre-infusion (pre-dose), immediately post-infusion, 3 hours, 6 hours and 10 hours post-infusion, Days 2, 3, 5, 8, 11, 15, 22, 29, 43, 57, 71 and 92.
PK blood sampling points: All subjects in the study will participate in the PK study. PK blood sampling timepoints: pre-infusion, immediately post-infusion, and 3 h, 6 h, 10 h, 24 h(Day 2), 48 h (day 3) , 96 h (day 5), 168 h (day 8) , 240h (day 11) , 336 h (day 15), 504 h (day 22) , 672 (day 29) , 1008 h (day 43) ,1344 h (day 57), 1680 h (day 71) , and 2184 h (day 92), after HLX70 infusion. There are a total of 17 blood sampling time points.
pre-infusion (pre-dose), immediately post-infusion, 3 hours, 6 hours and 10 hours post-infusion, Days 2, 3, 5, 8, 11, 15, 22, 29, 43, 57, 71 and 92.
PK parameters-Volume of distribution during terminal phase and at steady state
Zeitfenster: pre-infusion (pre-dose), immediately post-infusion, 3 hours, 6 hours and 10 hours post-infusion, Days 2, 3, 5, 8, 11, 15, 22, 29, 43, 57, 71 and 92.
PK blood sampling points: All subjects in the study will participate in the PK study. PK blood sampling timepoints: pre-infusion, immediately post-infusion, and 3 h, 6 h, 10 h, 24 h(Day 2), 48 h (day 3) , 96 h (day 5), 168 h (day 8) , 240h (day 11) , 336 h (day 15), 504 h (day 22) , 672 (day 29) , 1008 h (day 43) ,1344 h (day 57), 1680 h (day 71) , and 2184 h (day 92), after HLX70 infusion. There are a total of 17 blood sampling time points.
pre-infusion (pre-dose), immediately post-infusion, 3 hours, 6 hours and 10 hours post-infusion, Days 2, 3, 5, 8, 11, 15, 22, 29, 43, 57, 71 and 92.
PK parameters-Mean residence time
Zeitfenster: pre-infusion (pre-dose), immediately post-infusion, 3 hours, 6 hours and 10 hours post-infusion, Days 2, 3, 5, 8, 11, 15, 22, 29, 43, 57, 71 and 92.
PK blood sampling points: All subjects in the study will participate in the PK study. PK blood sampling timepoints: pre-infusion, immediately post-infusion, and 3 h, 6 h, 10 h, 24 h(Day 2), 48 h (day 3) , 96 h (day 5), 168 h (day 8) , 240h (day 11) , 336 h (day 15), 504 h (day 22) , 672 (day 29) , 1008 h (day 43) ,1344 h (day 57), 1680 h (day 71) , and 2184 h (day 92), after HLX70 infusion. There are a total of 17 blood sampling time points.
pre-infusion (pre-dose), immediately post-infusion, 3 hours, 6 hours and 10 hours post-infusion, Days 2, 3, 5, 8, 11, 15, 22, 29, 43, 57, 71 and 92.
Anti-drug antibody
Zeitfenster: pre-infusion and Days 15, 29, 57 and 92.
Blood sampling time points for immunogenicity: Blood samples for anti-drug antibody (ADA) testing will be collected at pre-infusion and on day 15, day 29, day 57, and day 92 after administration; positive ADA samples will be tested for neutralizing antibody (NAb).
pre-infusion and Days 15, 29, 57 and 92.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Voraussichtlich)

9. Dezember 2020

Primärer Abschluss (Voraussichtlich)

6. September 2021

Studienabschluss (Voraussichtlich)

18. September 2021

Studienanmeldedaten

Zuerst eingereicht

29. April 2022

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. Juni 2022

Zuerst gepostet (Tatsächlich)

23. Juni 2022

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

23. Juni 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. Juni 2022

Zuletzt verifiziert

1. Juni 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • HLX70-001US
  • 255086 (Andere Kennung: CRO study number)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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