Evaluate Safety and Pharmacokinetics of HLX70 in Healthy Adult Volunteers
NCT ID: NCT04561076
Last Updated: 2022-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2020-12-09
2021-09-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
OTHER
QUADRUPLE
Study Groups
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Sequence 1
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.
HLX70
Single-dose, intravenous infusion
Placebo
Single-dose, intravenous infusion
Sequence 2
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.
HLX70
Single-dose, intravenous infusion
Placebo
Single-dose, intravenous infusion
Sequence 3
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.
HLX70
Single-dose, intravenous infusion
Placebo
Single-dose, intravenous infusion
Interventions
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HLX70
Single-dose, intravenous infusion
Placebo
Single-dose, intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 confirm result.
5. Subject who agrees that he/she, and his/her spouse or partner, will use reliable contraception (see appendix 1) for 9 months after administration.
Exclusion Criteria
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.
18 Years
60 Years
ALL
Yes
Sponsors
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Sanyou Biopharmaceuticals(Shanghai)Co., Ltd
UNKNOWN
Shanghai ZJ Bio-Tech Co., Ltd
UNKNOWN
Hengenix Biotech Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Esther Yoon, MD
Role: PRINCIPAL_INVESTIGATOR
California Clinical Trials Medical Group (CCTMG) managed by Parexel
References
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Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Other Identifiers
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HLX70-001US-255086
Identifier Type: -
Identifier Source: org_study_id
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