Study of the Safety, Tolerability, and PK of SZEY-2108 Administered Intravenously to HVs in SAD and MAD Cohorts

NCT06055777 | Terminated Phase 1

• 1 other identifier: SZEY-2108-I-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Infections

Keywords

Healthy volunteers; SZEY-2108

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Secondary Outcomes (7)

• Assessment of Pharmacokinetic Parameter (plasma): Cmax measurement

  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

  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

  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

  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

  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)

Study Arms (4)

Single intravenous doses of SZEY-2108

ACTIVE COMPARATOR

Single escalating doses of SZEY-2108

Drug: SZEY-2108 for injetion

Single intravenous doses of placebo

PLACEBO COMPARATOR

Single intravenous doses of placebo to match SZEY-2108

Drug: Placebo

Multiple intravenous doses of SZEY-2108

ACTIVE COMPARATOR

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

PLACEBO COMPARATOR

Multiple intravenous doses of placebo at Q8h or Q6h on D1\~D7 and on the morning of D8.

Drug: Placebo

Interventions

SZEY-2108 for injetion DRUG

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

Multiple intravenous doses of SZEY-2108; Single intravenous doses of SZEY-2108

Placebo DRUG

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

Multiple intravenous doses of placebo; Single intravenous doses of placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Suzhou Erye Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Infections

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Xiaojie Wu

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 28, 2023
• Study Start: September 7, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)