AzTrials
AzTrials

Coronavirus Disease 2019(COVID-19)Phase 1NCT04483375

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

A Phase 1 study testing SCTA01 in people with Coronavirus Disease 2019(COVID-19), run by Sinocelltech Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Coronavirus Disease 2019(COVID-19)
What is being tested?
SCTA01
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
33 participants
Where
1 siteChina
Study dates
24 Jul 2020to 17 Nov 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.)

Who cannot join

  • 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;
Show all 23Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing SHIJITAN Hospital

    Beijing, Beijing Municipality, 100038

Other trials in China

About this study

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

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

Read the 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.

Being tested
SCTA01, Placebo
Keywords
COVID-19
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SCTA01Biological

    recombinant humanized anti-SARS-CoV-2 monoclonal antibody

  • PlaceboOther

    Placebo

Study groups in NCT04483375
Study groupRoleWhat they receive
anti-SARS-CoV-2 monoclonal antibody(SCTA01)ExperimentalSCTA01: single dose on Day0
Receives: Biological: SCTA01
PlaceboPlacebo comparatorPlacebo: single dose on Day0
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 7 days

  2. 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.

    Measured: 12 weeks

Secondary outcomes (6)

  1. AUC0-t

    Area under the curve from the time of dosing to the last measurable concentration time t (AUC0-t)

    Measured: 12 weeks

  2. AUC0-∞

    Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞)

    Measured: 12 weeks

  3. t1/2

    Elimination Phase Half-life(t1/2)

    Measured: 12 weeks

  4. Tmax

    Time to the Maximum Concentration(Tmax)

    Measured: 12 weeks

  5. Anti-drug antibody(ADA)

    Positive rate of anti-SCT A01 antibody

    Measured: 12 weeks

  6. 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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2020
  2. Study start24 Jul 2020
  3. Primary completion17 Nov 2020
  4. Study completion17 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04483375
Sponsor's protocol ID
SCTA01-X101
Status last verified
Jul 2020
First submitted
17 Jul 2020
Last updated
23 Mar 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 34491805

  • 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.

    PubMed 34473343

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SCTA01 in people with Coronavirus Disease 2019(COVID-19), run by Sinocelltech Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity(DLT) (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04483375, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in