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The First-in-human Study of SRN-001 in Healthy Participants
Bu çalışma, SRN-001 adlı yeni bir ilacın insanda ilk kez uygulandığı, güvenliliğinin ve vücuttaki davranışının incelendiği bir çalışmadır. Çalışmaya, 18-70 yaş arası sağlıklı gönüllüler alınmış ve katılımcılara SRN-001 ya da plasebo (etkisiz madde) verilmiştir. Çalışma Faz 1 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * Age 18-70 * BMI ≥18.0 kg/㎡ and ≤35 kg/㎡ * 12-lead triplicate electrocardiogram (ECG) readings within normal limits or with no clinically significant abnormalities * systolic blood pressure ≥ 90 mmHg and ≤160 mmHg; a diastolic blood pressure ≥ 50 mmHg and ≤95 mmHg; pulse ≥ 45 bpm and ≤100 bpm; tympanic temperature ≥ 35.5°C and ≤37.7°C and respiratory rate 12rpm to 22rpm * Negative urinary cotinine * Compliance to contraception and sperm donation restriction * Participants who are able and willing to give written informed consent * Fully vaccinated against SARS-CoV-2 Exclusion Criteria: * Who has clinically significant history * Who is with history of multiple drug allergies or history of allergic reaction to an oligonucleotide or common medicine (eg, aspirin, antibiotics, etc) or clinically significant hypersensitivity * No tolerance to IV injections or significant potential of intolerance * Clinically significant surgical history within 1 year * History of drug abuse or alcoholism within 2 years, and a restriction of consuming alcohol during study period * Pregnant or lactating females * Liver function test is 1.5 times greater than upper limit of normal (ULN) * Albumin ≥ 35 g/L and ≤ 50 g/L * Hb \< 115 g/L (female), \< 125 g/L (male) * estimated glomerular filtration rate (eGFR) \< 60 mL/min (CKD-EPI), 90 mL/min (MDRD) * Glucose \< 3 mmol/L * Positive screen for alcohol or drugs of abuse * HBsAg, Hepatitis B virus (HBV), Hepatitis C virus (HCV), or HIV infection * QTcF \> 450 msec for male, \> 470 msec for female * Inappropriate lab result by physician's discretion * Who have donated \> 500 mL of blood within 3 months * Who have received an investigational agent within 3 months, or 5 half-lives * Who have used prescription medication within 4 weeks including vaccines * Who have used OTC medication within 7 days * With clinically relevant wounds, following a clinically relevant surgery or have recently completed any invasive procedures (ie, Endoscopy) within 1 week, or who are scheduled for an elective surgical procedure * Who have a significant infection or known inflammatory process ongoing * Any conditions that, in physician's opinion, would make the participant unsuitable for enrollment or could interfere with the participant's participation