Evaluate Safety and Pharmacokinetics of HLX70 in Healthy Adult Volunteers

NCT ID: NCT05429385

Last Updated: 2022-06-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-09
• Study Completion Date: 2021-09-18

Brief Summary

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

Detailed Description

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

HLX70

Intervention Type: DRUG

Single-dose, intravenous infusion

Placebo

Intervention Type: DRUG

Single-dose, intravenous infusion

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.

Group Type: EXPERIMENTAL

HLX70

Intervention Type: DRUG

Single-dose, intravenous infusion

Placebo

Intervention Type: DRUG

Single-dose, intravenous infusion

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.

Group Type: EXPERIMENTAL

HLX70

Intervention Type: DRUG

Single-dose, intravenous infusion

Placebo

Intervention Type: DRUG

Single-dose, intravenous infusion

Interventions

HLX70

Single-dose, intravenous infusion

Intervention Type: DRUG

Placebo

Single-dose, intravenous infusion

Intervention Type: DRUG

Other Intervention Names

Recombinant Humanized Anti-S Protein Monoclonal Antibody for Injection

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hengenix Biotech Inc

INDUSTRY

Sponsor Role: collaborator

Sanyou Biopharmaceuticals(Shanghai)Co., Ltd

UNKNOWN

Sponsor Role: collaborator

Shanghai ZJ Bio-Tech Co., Ltd

UNKNOWN

Sponsor Role: collaborator

Shanghai Henlius Biotech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

255086

Identifier Type: OTHER

Identifier Source: secondary_id

HLX70-001US

Identifier Type: -

Identifier Source: org_study_id