Fig. 2: Study design, cohort enrollment and participant disposition. | Nature Medicine

Fig. 2: Study design, cohort enrollment and participant disposition.

From: Safety and pharmacokinetics of SARS-CoV-2 DNA-encoded monoclonal antibodies in healthy adults: a phase 1 trial

Fig. 2: Study design, cohort enrollment and participant disposition.

a, CONSORT-style diagram showing the number of participants screened, enrolled, dosed and included in the safety and PK analyses across all cohorts. aOne participant in cohort B received only one dose and was analyzed as part of cohort A1. b, Diagram of the study design and cohort progression. The trial followed a sequential dose-escalation strategy beginning with two single-dose cohorts: cohort A1 (0.5 mg, single dose) and cohort A2 (1.0 mg, single dose). Subsequent cohorts received multiple doses: cohort B (0.5 mg × 2 doses), cohort C (1.0 mg × 2 doses), cohort D (0.25 mg × 2 doses), cohort E (2.0 mg × 2 doses) and cohort G (0.5 mg × 4 doses; total 2.0 mg). Cohort G assessed repeated multisite injection and cohort F alternative EP parameters (0.5 mg × 2 doses). Enrollment into each cohort was sequential and contingent on safety review of the preceding group. Figure created using BioRender.com.

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