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This study is to test the safety, tolerability, pharmacokinetics (PK-the amount of study drug in the blood), and immunogenicity (how the study drug affects the immune system) of single dose and dose levels of an investigational drug called YQ23.
This is a first-in-man, phase 1, single-blind, randomized, placebo-controlled study in healthy volunteers. It will be conducted at a single centre and will enroll approximately 64 subjects. Subjects will either receive a single dose of study drug or placebo in a 3:1 ratio. Eight dose levels of YQ23 will be evaluated.
Each dose level group will be divided into 2 cohorts, with each cohort being dosed at last 24 hours apart. The leading cohort will comprise of 2 subjects, with 1 subject receiving YQ23 and 1 subject receiving placebo. The remaining cohort will comprise of 6 subjects, with 5 receiving YQ23 and 1 receiving placebo.
Safety assessments will be performed throughout the dosing and follow-up periods, and multiple PK samples will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose YQ23 | Active Comparator |
| |
| Single Dose Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YQ23 | Biological | Single dose of YQ23 delivered via intravenous route. Ascending dose levels will be evaluated |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety as assessed by the incidence of Treatment-emergent Adverse Events (TEAE) | Number of TEAEs will be listed according to the severity (mild, moderate, severe) as assessed by the Investigator. | From the time of signing the Informed Consent Form to final discharge from the study (approximately 8 weeks) |
| Safety as assessed by the incidence of laboratory abnormalities, based on haematology, clinical chemistry, and urinalysis test results | All serum biochemistry, haematology, and urinalysis data outside the clinical reference ranges will be listed by parameter and treatment. | From the time of signing the Informed Consent Form to D8 visit (approximately 36 days) |
| Safety as assessed by 12-lead electrocardiogram (ECG) | ECG parameters such as PR, QRS, QT and QTcF in milliseconds will be recorded. Clinically significant abdominal findings will be reported as Adverse Events (AE). | From the time of signing the Informed Consent Form to D8 visit (approximately 36 days) |
| Safety as assessed by echocardiogram | Clinically significant abnormal echocardiogram findings will be recorded as AEs. | From the time of signing the Informed Consent Form to D2 visit (approximately 30 days) |
| Safety as assessed by vital sign measurement of blood pressure | Systolic and Diastolic blood pressure (in mmHg) which is outside the clinical reference ranges and considered as clinically significant will be reported as AE. | From From the time of signing the Informed Consent Form to D8 visit (approximately 36 days) |
| Safety as assessed by vital sign measurement of pulse rate |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of YQ23 as assessed by Area under curve (AUC) on all subjects | Plasma levels of YQ23 will be serially evaluated following dosing of study drug, and the AUC will be calculated. | From study Day 1 (dosing of study drug) until Day 4 of trial participation. |
| Pharmacokinetics of YQ23 as assessed by the maximum concentration of YQ23 on all subjects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Billy Lau, PhD | New Beta Innovation Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance CRU Limited | Leeds | United Kingdom |
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Dose escalation study to determine the safe dose level.
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Single blind, placebo-controlled
| Matching Placebo | Biological | Single dose of the matching placebo delivered via intravenous route. |
|
Pulse rate (in beats/min) which is outside the clinical reference ranges and considered as clinically significant will be reported as AE. |
| From From the time of signing the Informed Consent Form to D8 visit (approximately 36 days) |
| Safety as assessed by vital sign measurement of oral body temperature | Body temperature (in degree Celsius) which is outside the clinical reference ranges and considered as clinically significant will be reported as AE. | From From the time of signing the Informed Consent Form to D8 visit (approximately 36 days) |
| Safety as assessed by local tolerability assessment: pain | The intravenous (IV) infusion site will be assessed for pain according to the following scale [Grade 0=none, 1=does not interfere with activity, 2=interferes with activity or requires repeated use of non-narcotic pain medication, 3=prevent daily activity or requires repeated use of narcotic pain medication, 4=requires medical intervention greater than analgesia]. Grade 3 or above will be recorded as AE. | From the time before dosing to D3 post dose (3 days) |
| Safety as assessed by local tolerability assessment: edema | The intravenous (IV) infusion site will be assessed for edema according to the following scale [Grade 0=0 to 24mm, 1=25 to 50mm and not interfere with activity, 2=51 to 100mm, or interferes with activity, 3=more than 100mm, and interferes with daily activity, 4=necrosis]. Grade 3 or above will be recorded as AE. | From the time before dosing to D3 post dose (3 days) |
| Safety as assessed by local tolerability assessment: erythema intensity | The intravenous (IV) infusion site will be assessed for erythema intensity according to the following scale [Grade 0=None, 1=light pink, 2=pinkish red, 3=intense red]. Grade 3 or above will be recorded as AE. | From the time before dosing to D3 post dose (3 days) |
| Safety as assessed by local tolerability assessment: erythema size | The intravenous (IV) infusion site will be assessed for erythema size according to the following scale [Grade 0=0 to 24mm, 1=25 to 50mm, 2=51 to 100mm, 3=more than 100mm, 4=necrosis or exfoliative dermatitis]. Grade 3 or above will be recorded as AE. | From the time before dosing to D3 post dose (3 days) |
Plasma levels of YQ23 will be serially evaluated following dosing of study drug, and the maximum plasma concentration (Cmax) will be calculated. |
| From study Day 1 (dosing of study drug) until Day 4 of trial participation. |