Evaluate Safety and Pharmacokinetics of HLX70 in Healthy Adult Volunteers

NCT ID: NCT04561076

Last Updated: 2022-04-01

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-09

Study Completion Date

2021-09-18

Brief Summary

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

Detailed Description

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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. The investigators 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.

Conditions

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COVID 19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Double-Blind, Placebo-Controlled

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.

Group Type EXPERIMENTAL

HLX70

Intervention Type DRUG

Single-dose, intravenous infusion

Placebo

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

HLX70

Intervention Type DRUG

Single-dose, intravenous infusion

Placebo

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

HLX70

Intervention Type DRUG

Single-dose, intravenous infusion

Placebo

Intervention Type OTHER

Single-dose, intravenous infusion

Interventions

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HLX70

Single-dose, intravenous infusion

Intervention Type DRUG

Placebo

Single-dose, intravenous infusion

Intervention Type OTHER

Other Intervention Names

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Anti-spike protein-1 monoclonal antibody (mAb)

Eligibility Criteria

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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 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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sanyou Biopharmaceuticals(Shanghai)Co., Ltd

UNKNOWN

Sponsor Role collaborator

Shanghai ZJ Bio-Tech Co., Ltd

UNKNOWN

Sponsor Role collaborator

Hengenix Biotech Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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.

Reference Type DERIVED
PMID: 34473343 (View on PubMed)

Other Identifiers

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HLX70-001US-255086

Identifier Type: -

Identifier Source: org_study_id

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