A Phase 1 interventional study of SZEY-2108 for injetion and Placebo in Infections, sponsored by Suzhou Erye Pharmaceutical Co., Ltd.. Terminated at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-03.
Sponsored by Suzhou Erye Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment
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 intravenous infusions, and the effect of exposure to SZEY-2108 after a single intravenous infusion on QT/QTc interval. Metabolites in each biological matrix (blood, urine, feces) and excretion characteristics (feces) after SZEY-2108 were analyzed.
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 subjects will be enrolled in Part 1 and they will be administrated with SZEY-2108 or placebo by single intravenous infusion. Part 1 consists of 7 cohorts: 100mg，200mg，500mg, 1000mg, 2000mg，4000mg and the dose of last cohort to be determined. Four subjects will be randomized to SZEY-2108 or placebo at a ratio of 1:1 in the 100mg cohort and eight subjects at a ratio of 3:1 in other each cohort. Time for intravenous infusion is 2h±5 min and it may be extended to 3 h±5 min if intolerance occur in 2000mg and 4000mg cohort.
Subjects will be randomised to receive an intravenous infusion of SZEY-2108 or placebo on the morning of D1, then they will still be hospitalised for safety, tolerability, pharmacokinetic and C-QTc assessment, and finally will discharge the Phase I clinical study centre after completion of all assessments at D3. They are required to return to the study centre at D7 for a safety follow-up visit.
Part 2: Multi-dose intravenous infusion dose-escalation trial According to results of Part 1, administration dose and dosing interval may be adjusted in Part 2.
Thirty healthy adult subjects will be enrolled in Part 2 and they will receive multiple doses of SZEY-2108 or placebo by intravenous infusion. Part 2 consists of 3 cohorts: 1000mg at Q8h，2000mg at Q8h, and one dose level of 1000mg, 1500mg or 2000mg at Q6h. Ten subjects will be randomized to SZEY-2108 or placebo at a ratio of 4:1 in each cohort. Time for intravenous infusion is 2h±5 min and it may be extended to 3 h±5 min if intolerance occur in 2000mg cohort.
Subjects will be randomized to receive an intravenous infusion of SZEY-2108 or placebo at Q8h or Q6h on D1\~D7 and on the morning of D8. They will still be hospitalised for safety, tolerability and pharmacokinetic assessment, and finally will discharge the Phase I clinical study centre after completion of all assessments at D9 or D10 (for faecal retention group). Subjects are required to return to the study centre at D15 for a safety follow-up visit.
6,701 studies on the registry are indexed under Infections; 801 are open to participants now.
This study's enrollment of 64 is below the median of 120 across 4,205 interventional studies indexed under Infections.
Browse Infections studies →This is the only study on the registry with Suzhou Erye Pharmaceutical Co., Ltd. as lead sponsor.
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Exclusion Criteria:
Single escalating doses of SZEY-2108
Drug: SZEY-2108 for injetion
Single intravenous doses of placebo to match SZEY-2108
Drug: Placebo
Multiple intravenous doses of SZEY-2108 at Q8h or Q6h on D1\~D7 and on the morning of D8.
Drug: SZEY-2108 for injetion
Multiple intravenous doses of placebo at Q8h or Q6h on D1\~D7 and on the morning of D8.
Drug: Placebo
Part1（Single-dose intravenous infusion dose-escalation trial）:100mg，200mg，500mg, 1000mg, 2000mg，4000mg and the dose of last cohort to be determined. Single intravenous doses on D1；Part 2（Multi-dose intravenous infusion dose-escalation trial）：1000mg at Q8h，2000mg at Q8h, and one dose level of 1000mg, 1500mg or 2000mg at Q6h. Multiple intravenous doses of SZEY-2108 at Q8h or Q6h on D1\~D7 and on the morning of D8.
Also known as: Novel monocyclic β-lactam antibiotics
Part1（Single-dose intravenous infusion dose-escalation trial）:250mL/500mL，Single intravenous doses on D1；Part 2（Multi-dose intravenous infusion dose-escalation trial）：250mL,Multiple intravenous doses of placebo at Q8h or Q6h on D1\~D7 and on the morning of D8.
Also known as: 0.9% Sodium Chloride Injection
Safety of single and multiple ascending doses of SZEY-2108
Safety and tolerability as assessed through the determination and recording of the occurrence of AEs as well as by adverse changes in vital signs, ECG (e.g. QTc interval) parameters, and laboratory data.
Time frame: Part 1: From the time of signed consent through the end of study date which occurs on Day 7±1;Part 2: From the time of signed consent through the end of study date which occurs on Day 15±1
Assessment of Pharmacokinetic Parameter (plasma): Cmax measurement
Maximum plasma concentration (Cmax µg/mL) on Day 1 after single infusion , maximum plasma concentration at steady state (Css,max µg/mL) after multiple infusion.
Time frame: In Part 1：0 to 24 hours post-dose on Day 1 ；In Part 2：0 to 24 hours post-dose on Days 1~7 and on the morning of D8 (varied intervals per cohort)
Assessment of Pharmacokinetic Parameter (plasma): AUC
Area under the plasma concentration-time curve from zero extrapolated to infinity (AUC µg\*h/mL) or AUC(0-last) in Part 1 on Day 1 after single infusion, area under the plasma concentration-time curve at steady state after multiple infusion (AUCss µg\*h/mL).
Time frame: In Part 1：0 to 24 hours post-dose on Day 1 ；In Part 2：0 to 24 hours post-dose on Days 1~7 and on the morning of D8 (varied intervals per cohort)
Assessment of Pharmacokinetic Parameter (plasma): Tmax
The time to maximum observed concentration of study drug in plasma
Time frame: In Part 1：0 to 24 hours post-dose on Day 1 ；In Part 2：0 to 24 hours post-dose on Days 1~7 and on the morning of D8 (varied intervals per cohort)
Assessment of Pharmacokinetic Parameter (plasma): t1/2
Terminal half-life (t1/2), on Day 1 after single infusion and at steady state after multiple infusion.
Time frame: In Part 1：0 to 24 hours post-dose on Day 1 ；In Part 2：0 to 24 hours post-dose on Days 1~7 and on the morning of D8 (varied intervals per cohort)
Assessment of Pharmacokinetic Parameter (plasma): CL
Systemic clearence (CL) on Day 1 after single infusion and at steady state after multiple infusion.
Time frame: In Part 1：0 to 24 hours post-dose on Day 1 ；In Part 2：0 to 24 hours post-dose on Days 1~7 and on the morning of D8 (varied intervals per cohort)
Assessment of Pharmacokinetic Parameter (urine): SZEY-2108
amount of SZEY-2108 excreted in urine
Time frame: In Part 1：Day1: baseline ,0 to 4, 4 to 8, 8 to 12 and 12 to 24h ；In Part 2：Day1: baseline,0 to 2, 2 to 4, 4 to 8, 8 to 12 and 12 to 24h.
Quantitative relationship between blood concentration and QTc interval of SZEY-2108.
C-QTc will be analyzed using concentration-QT (cQT) modeling
Time frame: In Part 1：Before dosing (Baseline) through 24 hours after the dose on Day 1 （The dose groups of 100mg and 200mg were excluded）
Plan to share: No
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This study is terminated, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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