Evaluate Safety and Pharmacokinetics of HLX70 in Healthy Adult Volunteers

COVID 19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04561076
• Other study ID #: HLX70-001US-255086
• Status: Withdrawn
• Phase: Phase 1
• Start date: December 9, 2020
• Est. completion date: September 18, 2021

Study information

• Verified date: March 2022
• Source: Hengenix Biotech Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 18, 2021
• Est. primary completion date: September 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID 19

Intervention

Drug:
• HLX70
Single-dose, intravenous infusion

Other:
• Placebo
Single-dose, intravenous infusion

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Hengenix Biotech Inc	Sanyou Biopharmaceuticals(Shanghai)Co., Ltd, Shanghai ZJ Bio-Tech Co., Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events, serious adverse event and infusion-related reactions as assessed by CTCAE v5.0		up to 92 days
Primary	Safety evaluation- proportion of subjects undergoing DLT events	The proportion of subjects undergoing DLT events	Days 1 to 7
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Anti-drug antibody	The number of presence subjects that develop of anti-durg antibody (immunogenicity)	pre-infusion and Days 15, day 29, day 57, and day 92