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

NCT04483375 | Completed Phase 1

• 1 other identifier: SCTA01-X101
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Disease 2019(COVID-19)

Keywords

COVID-19

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• AUC0-t

  12 weeks

• AUC0-∞

  12 weeks

• t1/2

  12 weeks

• Tmax

  12 weeks

• Anti-drug antibody(ADA)

  12 weeks

Study Arms (2)

anti-SARS-CoV-2 monoclonal antibody(SCTA01)

EXPERIMENTAL

SCTA01: single dose on Day0

Biological: SCTA01

Placebo

PLACEBO COMPARATOR

Placebo: single dose on Day0

Other: Placebo

Interventions

SCTA01 BIOLOGICAL

recombinant humanized anti-SARS-CoV-2 monoclonal antibody

anti-SARS-CoV-2 monoclonal antibody(SCTA01)

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (1)

Beijing SHIJITAN Hospital

Beijing, Beijing Municipality, 100038, China

Location

Related Publications (2)

• 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.

  PMID: 34491805 DERIVED

• 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.

  PMID: 34473343 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

upanovimab

Condition Hierarchy (Ancestors)

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

Study Officials

• Xinghe Wang, MD,PhD

  Beijing Shijitan Hospital, Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: July 23, 2020
• Study Start: July 24, 2020
• Primary Completion: November 17, 2020
• Study Completion: November 17, 2020
• Last Updated: March 23, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CN (1)