- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05429385
Evaluate Safety and Pharmacokinetics of HLX70 in Healthy Adult Volunteers
20 juni 2022 uppdaterad av: 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
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Fas
- Fas 1
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 60 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Subjects with voluntary signing of the informed consent form (ICF);
- Healthy males or females aged ≥ 18 and ≤ 60 years at the time of signing the ICF;
- 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 ;
- 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.
- Subject who agrees that he and his spouse or partner will use reliable contraception for 9 months after administration.
Exclusion Criteria:
- 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.
- 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.
- 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.
- Subjects with pneumonia or tuberculosis (TB) suggested by chest X-Ray.
- Subjects with previous exposure to a mAb or any other biological agents in 6 months before screening.
- 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.
- Subjects with previous participation in clinical trials receiving investigational drug/comparator within the longer of 30 days or 5 half-lives before screening.
- Subjects who are known to have a history of allergy to any mAb, biological product, protein product, or the ingredient of the IP.
- 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.
- Subjects who are known to have a history of psychotropic drug abuse, alcoholism, or drug addiction within the last year.
- Subjects with a history of a blood donation within 3 months before screening.
- Subjects with the use of any prescription drug, OTC drug, or traditional Chinese medicine in 14 days before screening.
- Females who are pregnant or breastfeeding
- Other factors that the Investigator deems inappropriate for participation in the 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: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
|
Engångsdos, intravenös infusion
Andra namn:
Single-dose, intravenous infusion
|
Experimentell: 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.
|
Engångsdos, intravenös infusion
Andra namn:
Single-dose, intravenous infusion
|
Experimentell: 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.
|
Engångsdos, intravenös infusion
Andra namn:
Single-dose, intravenous infusion
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of participants with adverse events, serious adverse event and infusion-related reactions as assessed by CTCAE v5.0
Tidsram: 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
Tidsram: Days 1 to 7.
|
The proportion of subjects undergoing DLT events
|
Days 1 to 7.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
PK parameters-Areas under the concentration-time curves
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
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 (Förväntat)
9 december 2020
Primärt slutförande (Förväntat)
6 september 2021
Avslutad studie (Förväntat)
18 september 2021
Studieregistreringsdatum
Först inskickad
29 april 2022
Först inskickad som uppfyllde QC-kriterierna
20 juni 2022
Första postat (Faktisk)
23 juni 2022
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
23 juni 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 juni 2022
Senast verifierad
1 juni 2022
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- HLX70-001US
- 255086 (Annan identifierare: CRO study number)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
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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Kliniska prövningar på HLX70
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Hengenix Biotech IncSanyou Biopharmaceuticals(Shanghai)Co., Ltd; Shanghai ZJ Bio-Tech Co., LtdIndragen