COVID 19
Conditions
Brief summary
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
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.
Interventions
DRUGHLX70
Single-dose, intravenous infusion
OTHERPlacebo
Single-dose, intravenous infusion
Sponsors
Sanyou Biopharmaceuticals(Shanghai)Co., Ltd
Shanghai ZJ Bio-Tech Co., Ltd
Hengenix Biotech Inc
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-Blind, Placebo-Controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events, serious adverse event and infusion-related reactions as assessed by CTCAE v5.0 | up to 92 days | — |
| Safety evaluation- proportion of subjects undergoing DLT events | Days 1 to 7 | The proportion of subjects undergoing DLT events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK parameters-Time from dosing to maximum measured concentration | 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 | 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 | 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-Areas under the concentration-time curves | 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 | 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 | 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 | pre-infusion and Days 15, day 29, day 57, and day 92 | The number of presence subjects that develop of anti-durg antibody (immunogenicity) |
| PK parameters-Clearance | 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 | 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. | — |
Outcome results
None listed