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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04483375
Recruitment Status : Completed
First Posted : July 23, 2020
Last Update Posted : March 23, 2021
Sponsor:
Information provided by (Responsible Party):
Sinocelltech Ltd.

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.

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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

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04483375


Locations
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China, Beijing
Beijing SHIJITAN Hospital
Beijing, Beijing, China, 100038
Sponsors and Collaborators
Sinocelltech Ltd.
Investigators
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Principal Investigator: Xinghe Wang, MD,PhD Beijing Shijitan Hospital, Capital Medical University
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Responsible Party: Sinocelltech Ltd.
ClinicalTrials.gov Identifier: NCT04483375    
Other Study ID Numbers: SCTA01-X101
First Posted: July 23, 2020    Key Record Dates
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)

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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:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases