Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LYNC-101 · 1 trial · 1 indication
Heart rate (HR), PR interval, QT interval, QRS interval, and QTcF interval should be recorded. During the screening period, if an abnormal corrected QT interval (QTcF) is determined by the Investigator, it may be re-measured up to 2 times, with a recommended interval of at least 5 minutes between each measurement, and the average QTcF value of the three measurements should be calculated. QTcF = QT/(RR\^0.33), RR = 60 / HR. During the study, the Investigator will determine whether a repeat measurement is necessary.
Including sitting blood pressure, respiration, pulse, and body temperature (axillary, tympanic, or forehead temperature are all acceptable, but participants at the same study site must use a consistent method). Vital signs will be measured at the times specified in the study schedule. Additional vital sign tests may be performed during the study if abnormalities are clinically significant.
Physical examinations will be conducted according to the study assessment schedule. Comprehensive physical examinations include general condition (including overall appearance, skin, mucous membranes, lymph nodes, etc.), head, neck, chest, abdomen, spine and extremities, and nervous system, and other.
Laboratory tests shall be performed according to the study assessment schedule. The Investigator must evaluate all values outside the normal range (CS: clinically significant; NCS: not clinically significant) and sign with their name and date. Only abnormalities judged by the Investigator as CS and meeting the definition of AE shall be recorded as an AE. In this study, the Investigator may, at their own discretion, perform additional or repeated tests if deemed necessary.
| Arm | Type | Description |
|---|---|---|
| SAD:dose 1 | EXPERIMENTAL | 1 receiving LYNC-101 for Injection and 1 receiving placebo |
| SAD:dose2 | EXPERIMENTAL | 6 to receive LYNC-101 for Injection and 2 to receive placebo |
| SAD:dose3 | EXPERIMENTAL | 6 to receive LYNC-101 for Injection and 2 to receive placebo |
| SAD:dose4 | EXPERIMENTAL | 6 to receive LYNC-101 for Injection and 2 to receive placebo |
| SAD:dose5 | EXPERIMENTAL | 6 to receive LYNC-101 for Injection and 2 to receive placebo |
| MAD:dose1 | EXPERIMENTAL | 6 to receive LYNC-101 for Injection and 2 to receive placebo |
| MAD:dose2 | EXPERIMENTAL | 6 to receive LYNC-101 for Injection and 2 to receive placebo |
| Name | Type | Description |
|---|---|---|
| LYNC-101 | DRUG | SAD:Administered as a single dose via intravenous infusion. MAD:Administered via intravenous infusion every 3 weeks. |
| LYNC-101 Placebo | DRUG | LYNC-101 Placebo SAD:Administered as a single dose via intravenous infusion. MAD:Administered via intravenous infusion every 3 weeks. |
Inclusion Criteria: 1. Healthy male or female participants aged 18-60 years (inclusive). 2. Body weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI) of 18-32 kg/m² (inclusive). 3. Able to fully understand the study, voluntarily agree to participate in the study, and sign ...
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