Status:
TERMINATED
Study of the Safety, Tolerability, and PK of SZEY-2108 Administered Intravenously to HVs in SAD and MAD Cohorts
Lead Sponsor:
Suzhou Erye Pharmaceutical Co., Ltd.
Conditions:
Infections
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This phase 1 study was designed to evaluate the safety and tolerability of SZEY-2108 in single and multiple intravenous infusions, the pharmacokinetic profile of SZEY-2108 after single and multiple in...
Detailed Description
This is a first-in-human, randomized, double-blind, placebo-controlled study consisting of 2 parts. Part 1: Single-dose intravenous infusion dose-escalation trial. A total of 44 \~ 52 healthy adult su...
Eligibility Criteria
Inclusion
- Age between 18 and 45 years at the time of screening;
- BMI between 19 and 28 kg/m2, and weight for males and females ≥ 50kg and 45kg, respectively;
- No clinical relevant abnormalities
- Sign informed consent
Exclusion
- Any clinical significant illness
- Other medical or psychiatric may inappropriate for the study
- Past history of allergic conditions or current comorbid allergies
- Use of any prescription medications within 4 weeks prior to screening or use of any over-the-counter medications, herbs, supplements, and vitamins within 7 days prior to the use of the investigational drug;
- History of cigarette, alcohol or drug abuse
- Abnormal vital signs, such as blood pressure and pulse rate
- Abnormal examination results, such as 12-ECG, eGFR, ALT, AST and TBL
- Positive results of HBsAg, TPPA, HCV-Ab, or HIV-Ab
- Blood loss or donation \> 400ml within 3 months prior to screening
- Pregant or breastfeeding females or subjects unwilling to contraception
Key Trial Info
Start Date :
September 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2024
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06055777
Start Date
September 7 2023
End Date
May 31 2024
Last Update
December 3 2024
Active Locations (1)
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1
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200000