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

• ClinicalTrials.gov Identifier: NCT04483375
• Recruitment Status: Completed
• First Posted: July 23, 2020
• Last Update Posted: March 23, 2021
• Sponsor: Sinocelltech Ltd.
• Information provided by (Responsible Party): Sinocelltech Ltd.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Coronavirus Disease 2019(COVID-19)	Biological: SCTA01; Other: Placebo	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blinded, Placebo-controlled, Single Ascending Dose, Phase I Study to Evaluate the Tolerability, Safety, Pharmacokinetics of SCTA01 in Healthy Subjects
• Actual Study Start Date: July 24, 2020
• Actual Primary Completion Date: November 17, 2020
• Actual Study Completion Date: November 17, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Dose-limiting toxicity(DLT) [ Time Frame: 7 days ]
   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
2. Maximal Tolerable Dose(MTD) [ Time Frame: 12 weeks ]
   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.

Secondary Outcome Measures :

1. AUC0-t [ Time Frame: 12 weeks ]
   Area under the curve from the time of dosing to the last measurable concentration time t (AUC0-t)
2. AUC0-∞ [ Time Frame: 12 weeks ]
   Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞)
3. t1/2 [ Time Frame: 12 weeks ]
   Elimination Phase Half-life(t1/2)
4. Tmax [ Time Frame: 12 weeks ]
   Time to the Maximum Concentration(Tmax)
5. Anti-drug antibody(ADA) [ Time Frame: 12 weeks ]
   Positive rate of anti-SCT A01 antibody
6. Adverse events [ Time Frame: 12 weeks ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

China, Beijing

Beijing SHIJITAN Hospital

Beijing, Beijing, China, 100038

Sponsors and Collaborators

Sinocelltech Ltd.

Investigators

• Principal Investigator: Xinghe Wang, MD,PhD; Beijing Shijitan Hospital, Capital Medical University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Sinocelltech Ltd.
• ClinicalTrials.gov Identifier: NCT04483375
• Other Study ID Numbers: SCTA01-X101
• First Posted: July 23, 2020
• Last Update Posted: March 23, 2021
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP)

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sinocelltech Ltd.:

COVID-19

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases