1. SciScore for 10.1101/2021.07.21.21260964: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    EthicsField Sample Permit: These studies were conducted at a single phase 1 unit in China from July 2020 to February 2021 (registered at ClinicalTrials.gov under registration number NCT04479631 and NCT04479644).
    IACUC: The study protocol, amendments, and informed-consent forms were reviewed and approved by Ethical Review Committee at the site.
    Consent: Participants provided written informed consent before any study-related procedures were performed.
    Sex as a biological variableEligible participants were healthy male or female adults aged 18 to 49 years, had a body weight ≤100 kg and a body mass index of 18-24 kg/m2, and were in good health determined by no clinically significant findings from medical history, physical examination including vital signs, electrocardiogram (ECG), and clinical laboratory assessments.
    RandomizationStudy design and participants: BRII-196-001 and BRII-198-001 are two first-in-human phase 1, randomized, single-blind, placebo-controlled, single ascending dose escalation studies in which BRII-196 and BRII-198 were evaluated respectively among healthy adults.
    Blindingnot detected.
    Power Analysisnot detected.
    Cell Line AuthenticationAuthentication: BRII-196 or BRII-198 serum concentrations were measured using validated enzyme linked immunosorbent assays (ELISA) with the lower limit of quantitation (LLOQ) at 150 ng/mL.

    Table 2: Resources

    Serum samples for anti-drug antibody (ADA) assays were collected at the following time points: pre-dose on day 1 and at days 15, 31, and 181.
    suggested: None
    Software and Algorithms
    The PK parameters were estimated by non-compartmental analyses using WinNonlin module in the Phoenix Platform (version, Certara Inc., Princeton, NJ 08540).
    Phoenix Platform
    suggested: None

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    NCT04479631CompletedSafety, Tolerability, and Pharmacokinetics Study of Human Mo…
    NCT04479644CompletedSafety, Tolerability, and Pharmacokinetics Study of Human Mo…

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    Results from scite Reference Check: We found no unreliable references.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

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