InfectionsPhase 1NCT06055777
Study of the Safety, Tolerability, and PK of SZEY-2108 Administered Intravenously to HVs in SAD and MAD Cohorts
A Phase 1 study testing SZEY-2108 for injetion in people with Infections, run by Suzhou Erye Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections
- What is being tested?
- SZEY-2108 for injetion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2023to 31 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200000
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of SZEY-2108 Administreated as Single and Repeated Intravenous Doses in Chinese Healthy Subjects
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.
Read the 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 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.
- Conditions
- Infections
- Being tested
- SZEY-2108 for injetion, Placebo
- Keywords
- Healthy volunteers, SZEY-2108
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SZEY-2108 for injetionDrug
Also called Novel monocyclic β-lactam antibiotics
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.
PlaceboDrug
Also called 0.9% Sodium Chloride Injection
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.
| Study group | Role | What they receive |
|---|---|---|
| Single intravenous doses of SZEY-2108 | Active comparator | Single escalating doses of SZEY-2108 Receives: Drug: SZEY-2108 for injetion |
| Single intravenous doses of placebo | Placebo comparator | Single intravenous doses of placebo to match SZEY-2108 Receives: 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: In Part 1：Before dosing (Baseline) through 24 hours after the dose on Day 1 （The dose groups of 100mg and 200mg were excluded）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start7 Sep 2023
- Primary completion31 May 2024
- Study completion31 May 2024
Why it stopped: Due to the termination criteria for dose escalation in the clinical protocol having been reached, this trial is terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Erye Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaojie Wu, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055777
- Sponsor's protocol ID
- SZEY-2108-I-01
- Status last verified
- Nov 2024
- First submitted
- 13 Sep 2023
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of SZEY-2108 Administreated as Single and Repeated Intravenous Doses in Chinese Healthy Subjects
- ClinicalTrials.gov ID
- NCT06055777
- Acronym / sponsor ID
- SZEY-2108-I-01
- Conditions
- Infections
- Keywords
- Healthy volunteers, SZEY-2108
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the termination criteria for dose escalation in the clinical protocol having been reached, this trial is terminated.
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Suzhou Erye Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single intravenous doses of SZEY-2108 | Active comparator | Drug: SZEY-2108 for injetionSingle escalating doses of SZEY-2108 |
| Single intravenous doses of placebo | Placebo comparator | Drug: PlaceboSingle intravenous doses of placebo to match SZEY-2108 |
| Multiple intravenous doses of SZEY-2108 | Active comparator | Drug: SZEY-2108 for injetionMultiple intravenous doses of SZEY-2108 at Q8h or Q6h on D1~D7 and on the morning of D8. |
| Multiple intravenous doses of placebo | Placebo comparator | Drug: PlaceboMultiple intravenous doses of placebo at Q8h or Q6h on D1~D7 and on the morning of D8. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SZEY-2108 for injetionAlso: Novel monocyclic β-lactam antibioticsPart1（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. | Drug | Multiple intravenous doses of SZEY-2108, Single intravenous doses of SZEY-2108 |
| PlaceboAlso: 0.9% Sodium Chloride InjectionPart1（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. | Drug | Multiple intravenous doses of placebo, Single intravenous doses of placebo |
Primary outcome
Safety of single and multiple ascending doses of SZEY-2108
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
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.
7 secondary outcomes
Assessment of Pharmacokinetic Parameter (plasma): Cmax measurement
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
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
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
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
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
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.
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）
Results and safety
The study was stopped early (reason given: Due to the termination criteria for dose escalation in the clinical protocol having been reached, this trial is terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaojie Wu principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SZEY-2108 for injetion in people with Infections, run by Suzhou Erye Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to the termination criteria for dose escalation in the clinical protocol having been reached, this trial is terminated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of single and multiple ascending doses of SZEY-2108 (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.