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

A Randomized, Double-blinded, Placebo-controlled, Single Ascending Dose, Phase I Study to Evaluate the Tolerability, Safety, Pharmacokinetics of SCTA01 in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Coronavirus Disease 2019(COVID-19)
• Intervention / Treatment: Other: Placebo; Biological: SCTA01

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100038
      • Beijing Shijitan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: anti-SARS-CoV-2 monoclonal antibody(SCTA01); SCTA01: single dose on Day0	Biological: SCTA01; recombinant humanized anti-SARS-CoV-2 monoclonal antibody
Placebo Comparator: Placebo; Placebo: single dose on Day0	Other: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose-limiting toxicity(DLT)	DLT will be assessed by DAIDS v2.1. The measurements include clinical symptoms and abnormal vital signs, abnormal laboratory tests (complete blood cell count, serum chemistry, routine urinalysis, coagulation function, etc.) and 12-lead ECGs	7 days
Maximal Tolerable Dose(MTD)	MTD will be assessed by DAIDS v2.1. The measurements include clinical symptoms and abnormal vital signs, abnormal laboratory tests (complete blood cell count, serum chemistry, routine urinalysis, coagulation function, etc.) and 12-lead ECGs.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-t	Area under the curve from the time of dosing to the last measurable concentration time t (AUC0-t)	12 weeks
AUC0-∞	Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞)	12 weeks
t1/2	Elimination Phase Half-life(t1/2)	12 weeks
Tmax	Time to the Maximum Concentration(Tmax)	12 weeks
Anti-drug antibody(ADA)	Positive rate of anti-SCT A01 antibody	12 weeks
Adverse events	Adverse events as assessed by DAIDS v2.1, including clinical symptoms and abnormal vital signs, abnormal laboratory tests (complete blood cell count, serum chemistry, routine urinalysis, coagulation function, etc.) and 12-lead ECGs	12 weeks

Collaborators and Investigators

• Sponsor: Sinocelltech Ltd.
• Investigators: Principal Investigator: Xinghe Wang, MD,PhD, Beijing Shijitan Hospital, Capital Medical University

Publications and helpful links

General Publications

• 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.
• Li Y, Qi L, Bai H, Sun C, Xu S, Wang Y, Han C, Li Y, Liu L, Cheng X, Liu J, Lei C, Tong Y, Sun M, Yan L, Chen W, Liu X, Liu Q, Xie L, Wang X. Safety, Tolerability, Pharmacokinetics, and Immunogenicity of a Monoclonal Antibody (SCTA01) Targeting SARS-CoV-2 in Healthy Adults: a Randomized, Double-Blind, Placebo-Controlled, Phase I Study. Antimicrob Agents Chemother. 2021 Oct 18;65(11):e0106321. doi: 10.1128/AAC.01063-21. Epub 2021 Sep 7.

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2020
• Primary Completion (Actual): November 17, 2020
• Study Completion (Actual): November 17, 2020

Study Registration Dates

• First Submitted: July 17, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 21, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: SCTA01-X101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No