Healthy volunteers help test new drug form

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Volunteers had to meet all the following inclusion criteria: 1. Signed and dated Informed Consent Form in duplicate 2. Males and females aged 18-45 years inclusive 3. Body mass index: * Cohorts A and B: normal range (18.5-29.9 kg/m²) * Cohort C: normal range (18.5-29.9 kg/m²), body mass ≥55 and ≤100 kg 4. Verified "healthy" diagnosis per standard clinical, laboratory, and instrumental examinations: 1. Normal results for complete blood count, blood chemistry, coagulation tests, urinalysis, and ECG per center standards (screening tests performed ≤7 days before enrollment) 2. Normal vital signs: SBP 90-129 mmHg, DBP 60-85 mmHg, pulse 60-100 bpm, body temperature 36.1-37.0℃, respiratory rate 12-20 breaths/min 3. No tuberculosis (active, latent, or history) or other chronic infections/inflammatory diseases 4. Satisfactory health status (per volunteer's opinion) for 30 days prior to consent 5. "Normal" result for physical examination by investigator's judgment at screening 5. Agreement to abstain from alcohol for 72 hours pre-dose until final PK blood sampling 6. Willingness to comply with protocol procedures per investigator's judgment 7. Agreement (by volunteers and their partners of reproductive potential for male volunteers) to abstain from heterosexual intercourse or use highly effective contraception from consent until 3 months post-goflikicept administration 8. For female volunteers: willingness to consent to pregnancy outcome data collection and provide obstetric/pediatric clinic contacts if pregnancy occurs post-dosing Subjects were withdrawn from further participation in the study in the following cases: 1. Detection, after inclusion of the subject in the study, of non-compliance with the inclusion criteria or presence, at the time of inclusion, of compliance with the exclusion criteria (as decided by LLC "R-Pharm International", including retrospective analysis of information entered into the eCRF database) 2. If the subject withdraws their consent to participate in the study 3. If AEs or SAEs, laboratory abnormalities, or concomitant diseases are identified in the subject, which, in the opinion of the investigator or the Sponsor, make continued participation impossible or dangerous, or not in the best interest of the subject's welfare and safety 4. In case of subject non-compliance (in this case, exclusion of the subject must be agreed upon with representatives of LLC "R-Pharm International", see Section 6.3 of the Clinical Study Protocol), or in the case of systematic major deviations in the timing of scheduled visits (more than 3 deviations from scheduled visit dates). For Cohort C: in case of missing any of Visits 09, missing two consecutive Visits 1015, or missing any 3 visits during the study 5. If the study is terminated by decision of LLC "R-Pharm International", local ethics committees, or regulatory authorities 6. In case of use of drugs prohibited by the Protocol 7. If restrictions for study subjects are violated (in this case, exclusion of the subject must be agreed upon with representatives of LLC "R-Pharm International", see Section 6.2.3 of the Clinical Study Protocol "Other restrictions for study subjects") 8. If there is suspicion of concurrent participation in another clinical study, including indirect laboratory evidence 9. If the result of a test for alcohol, narcotic, or psychotropic substances is positive before administration of the study drug 10. If SARS-CoV-2 is detected via PCR test or rapid antigen test prior to administration of the study drug 11. If other reasons arise during the study that prevent the study from being conducted according to the protocol 12. In the event of the subject's death 13. For female subjects a positive pregnancy test (test strip), performed at the center prior to administration of the study drug 14. In case of missed blood sample collections (applicable only for Cohort C)