Evaluation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BT-114143 Injection … (NCT07169240) | Clinical Trial Compass
CompletedPhase 1
Evaluation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BT-114143 Injection in Healthy Subjects
China84 participantsStarted 2023-02-06
Plain-language summary
This study is a single-center, randomized, double-blind, placebo-controlled, single dose escalation design to evaluate the safety, tolerability, and pharmacokinetic characteristics of BT-114143 Injection.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion Criteria:
* Subjects have been informed of the details of this study before the trial, have signed a written informed consent form, and voluntarily participate in the study;
* Healthy female or male subjects aged 18-55 years (inclusive) at the time of screening;
* Male subjects with a body weight of ≥50.0 kg and female subjects with a body weight of ≥45.0 kg; body mass index (BMI) ranging from 18.5 to 28 kg/m² (inclusive) \[BMI = weight (kg) / height² (m²)\];
* No history of abnormal eye color vision, or diseases related to the heart, liver, kidney, digestive system, nervous system, mental disorders, metabolic disorders, or blood system; those whose evaluations in terms of medical history, physical examination, vital signs, chest X-ray (posteroanterior), abdominal color Doppler ultrasound, ECG, and laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function, etc.) are normal or show mild abnormalities with no clinical significance, and are deemed eligible by the researcher.
Exclusion Criteria:
* Confirmed as COVID-19 patients or asymptomatic infected persons upon inquiry;
* Subjects who have undergone major surgery within 6 months prior to screening, or plan to undergo surgery during the study, as well as those who have previously undergone surgeries that may affect drug absorption, distribution, metabolism, or excretion (excluding appendectomy);
* Subjects with a history of or persistent arterial or venous thrombosis, or at high risk…
What they're measuring
1
Safety and tolerability of BT-114143
Timeframe: For single administration, the follow-up will last until Day 15 after dosing; for multiple administrations, the follow-up will last until Day 21 after dosing.