Safety, Tolerability and Pharmacokinetics of SCTA01, an Anti-SARS-CoV-2 Monoclonal Antibody, in Healthy Chinese Subjects

Sinocelltech

Status and phase

Completed

Phase 1

Conditions

Coronavirus Disease 2019(COVID-19)

Treatments

Other: Placebo

Biological: SCTA01

Study type

Interventional

Funder types

Industry

Identifiers

NCT04483375

SCTA01-X101

Details and patient eligibility

About

The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics of SCTA01(anti-SARS-CoV-2 monoclonal antibody) in Healthy Chinese Subjects.

Full description

This is a Phase 1, First-in-Human, Randomized, Double-blinded, Placebo-Controlled, Single Ascending Dose Study of SCTA01(Anti-SARS-CoV-2 monoclonal antibody) in Healthy Chinese Subjects.

Dose escalation will be guided by a safety review of clinical signs and symptoms, adverse events (AEs), and laboratory results of the prior dose cohort.

An Interim analysis will be performed after Day 28 post-dose for the last dose cohort for review.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Able to provide written informed consent
Males or females. Aged ≥ 18 years old
Body mass index (BMI) between 18.0 and 26.0 kg/m2
Normal or abnormal but non-clinical significant physical examination, vital signs, 12-ECG and chest CT, etc
No plan of pregnancy and being willing to use effective contraceptive measures (including partner) from informed consent to 6 months after administration of SCTA01/placebo (abstinence，sterilization operation，contraceptive barrier，acyeterion , etc.)

Exclusion criteria

Having a history of severe allergy, such as severe allergic reactions, urticaria, angioedema;
Having one of the following evidence on SARS-CoV-2 infection(previous tests were accepted)：
- SARS-CoV-2 positive: reverse transcription-polymerase chain reaction (RT-PCR) and/or next generation sequencing (NGS)
- Previous viral gene sequencing showed high homology with the known SARS-CoV-2
- Positive specific antibody IgM or IgG against serum SARS-CoV-2
Having a history of severe allergies, such as severe allergic reactions, urticaria, angioedema;
Having active infection or fever before to enrollment(≥ 37.3℃)
Having primary disease in main organs, such as heart, lung, kidney, liver, nervous system, gastrointestinal system dysfunction, history of thrombocytopenia or abnormal bleeding
Suffering from autoimmune diseases or a history of autoimmune diseases (such as systemic lupus erythematosus, thyroid Inflammation, vasculitis, etc.)
Within 7 days prior to the first dose of SCTA01/placebo, subject has received any prescription drugs, non-prescription drugs, Chinese herbal medicines and health products
Within 3 months prior to the first dose of SCTA01/placebo, subjects who participated in other clinical study, or remaining in the elimination period of the drug (within 5 half-lives) before treatment
Within 30 days prior to the first dose of SCTA01/placebo, subjects who have received vaccine
Within 3 months prior to the first dose of SCTA01/placebo, subjects who have received blood product treatment or blood donation and hemorrhage ≥400mL, or subjects who has a blood donation plan within 3 months after treatment
Within 6 months prior to the first dose of SCTA01/placebo, subjects who have received major surgery, or has surgery plan during clinical trail
Pregnant or lactating women or positive β-HCG, has plan of pregnancy from informed consent signed to 6 months after administration of SCTA01/placebo
Positive of anti-HIV, TP-Ab, anti-HCV, anti-HBV
Having a history of epilepsy
Having a history of malignancies
Within 3 months prior to screening, sujects who have drunk more than 14 standard units (1 standard unit contains 14g alcohol, such as 360mL beer, 45mL spirits with 40% alcohol or 150mL wine), or positive of alcohol breath test
Within 3 months prior to screening, subjects who smoked more than 5 cigarettes per day, do not accept smoking cessation during the study
Having a history of drug addiction and drug abuse; or who have a positive urine test result for drug abuse; or cannot guarantee that they will not abuse drugs during the study
Subjects who are not able to follow the plan to complete the study
Subjects who are not considered suitable for the study by investigators