Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Subcutaneous Doses of BI 3006337 in Healthy Male Subjects (Single-blind, Partially Randomised Within Dose Groups, Placebo-controlled, Parallel (Sequential) Group Design)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Number of Subjects With Drug-related Adverse Events (AEs) After a Single Dose of BI 3006337
研究概览
简要总结
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics of BI 3006337 in healthy male subjects following subcutaneous administration of single-rising doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Temperature, blood pressure (BP), pulse rate (PR)), 12-lead ECG, and clinical laboratory tests
- •Age of ≥18 to ≤55 years at screening (SCR)
- •BMI of ≥20.0 to <32.0 kg/m2 at SCR
- •A minimum absolute body weight (BW) of 70 kilograms (kg) at SCR
- •Male subjects who meet any of the following criteria from the administration of trial medication until 30 days after administration of trial medication:
- •Use of adequate contraception, e.g. any of the following methods (of female partners) plus condom or sexually abstinence (if lifestyle-related): implants, injectables, vaginal contraceptives, intrauterine device, oral contraception (failure rate <1%). In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
- •Surgically sterilised/vasectomised (including hysterectomy with or without bilateral salpingectomy or bilateral oophorectomy of female partner. In case of salpingectomy or oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment).
- •Postmenopausal female partner, defined as at least 1 year of spontaneous amenorrhea.
- •Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
排除标准
- •Female gender
- •Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
- •3 times repeated measurement of systolic BP outside the range of 90 to 150 mmHg, diastolic BP outside the range of 50 to 90 mmHg, or PR outside the range of 40 to 100 bpm. In case of documented white coat hypertension the decision for eligibility is left to the investigator.
- •Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters Alanine Transaminase (ALT) (1.25xupper limit of normal (ULN)), Aspartate Transaminase (AST) (1.25xULN) and Total Bilirubin (T-BIL) (1.5xULN) or renal parameters (creatinine 1.25xULN) exceeding the Upper Limit of Normal (ULN) as specified: after 2 times repeated measurements
- •Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- •Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
- •History of relevant orthostatic hypotension, fainting spells, or blackouts
- •Chronic or relevant acute infections, including positive tests for Hepatitis (Hep) B antigen/ Hep C antibodies, Human immunodeficiency virus (HIV)-1/2 antibodies and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
- •Further exclusion criteria apply
研究组 & 干预措施
BI 3006337 15 mg
Solution for subcutaneous (s.c) injection containing 15 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
干预措施: BI 3006337 (Drug)
BI 3006337 30 mg
Solution for subcutaneous (s.c) injection containing 30 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
干预措施: BI 3006337 (Drug)
BI 3006337 50 mg
Solution for subcutaneous (s.c) injection containing 50 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
干预措施: BI 3006337 (Drug)
BI 3006337 0.2 mg
Solution for subcutaneous (s.c) injection containing 0.2 milligrams (mg) of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
干预措施: BI 3006337 (Drug)
BI 3006337 0.5 mg
Solution for subcutaneous (s.c) injection containing 0.5 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
干预措施: BI 3006337 (Drug)
BI 3006337 1 mg
Solution for subcutaneous (s.c) injection containing 1 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
干预措施: BI 3006337 (Drug)
BI 3006337 2 mg
Solution for subcutaneous (s.c) injection containing 2 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
干预措施: BI 3006337 (Drug)
BI 3006337 4 mg
Solution for subcutaneous (s.c) injection containing 4 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
干预措施: BI 3006337 (Drug)
BI 3006337 8 mg
Solution for subcutaneous (s.c) injection containing 8 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
干预措施: BI 3006337 (Drug)
BI 3006337 100 mg
Solution for subcutaneous (s.c) injection containing 100 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
干预措施: BI 3006337 (Drug)
BI 3006337 150 mg
Solution for subcutaneous (s.c) injection containing 150 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
干预措施: BI 3006337 (Drug)
Placebo
This arm comprises all placebo-treated participants in the trial who were equally distributed across dose groups. Solution for subcutaneous (s.c) injection of placebo was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Subjects With Drug-related Adverse Events (AEs) After a Single Dose of BI 3006337
时间窗: From 1 day pre-dose till end of trial, up to 40 days
Number of subjects with drug-related adverse events (AEs) after a single dose of BI 3006337 is reported. For drug-related adverse events, medical judgment was used to determine whether there was a reasonable possibility of a causal relationship between the AE and the given trial treatment, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confounding factors such as concomitant medication, concomitant diseases and relevant history.
次要结局
- Area Under the Concentration-time Curve of BI 3006337 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)(Within 2 hours (h) before drug intake and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, 672 h after drug intake and at Day 36.)
- Maximum Measured Concentration of BI 3006337 in Serum (Cmax)(Within 2 hours (h) before drug intake and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, 672 h after drug intake and at Day 36.)
- Time From Dosing to the Maximum Measured Concentration of BI 3006337 in Serum (Tmax)(Within 2 hours (h) before drug intake and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, 672 h after drug intake and at Day 36.)