临床试验/NCT03995550

NCT03995550撤回1 期

A Randomised, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LEO 142397 in Healthy Subjects

LEO Pharma2 个研究点分布在 1 个国家开始时间: 2019年7月3日最近更新: 2026年5月1日

适应症

干预措施

试验速览

阶段: 1 期
状态: 撤回
发起方: LEO Pharma
试验地点: 2
主要终点: Part 1. Number of treatment-emergent adverse events per subject

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is the first clinical trial with LEO 142397. The purpose of the trial is to assess the safety and tolerability of LEO 142397, along with the pharmacokinetics (what the body does to the drug) and the pharmacodynamics (what the drug does to the body) in healthy people.

The trial consists of 2 parts:

In Part 1, participants will receive a single dose of LEO 142397. There will be up to 8 different dose groups.
In Part 2, participants will receive a daily dose of LEO 142397 for 14 days. There will be up to 6 different dose groups.

Each participant will be enrolled into 1 dose group in either Part 1 or Part 2.

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: Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Body mass index of 18.0-32.0 kg/m2, inclusive.
•In good health at screening and check-in as judged by the investigator based on medical history, physical examination, vital signs assessment, 12-lead electrocardiogram, and clinical laboratory evaluations:
•Aspartate aminotransferase and alanine aminotransferase values ≤1.5 times the upper limit of normal.
•Congenital nonhaemolytic hyperbilirubinaemia (including suspicion of Gilbert's syndrome) is not acceptable.
•Haemoglobin value, neutrophil count, and lymphocyte count ≥ the lower limit of normal.
•Female subjects of childbearing potential must use a highly effective form of birth control, in conjunction with adequate barrier contraception, from randomisation until 90 days after the follow-up visit.
•Male subjects with female partner of childbearing potential must use adequate male barrier contraception, in conjunction with a highly effective form of female contraception for the partner, from randomisation until 90 days after the follow-up visit.

排除标准

•Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of any drug.
•Any medication, including St. John's wort, known to chronically alter drug absorption or elimination processes within 30 days prior to the first dose.
•History of any significant infectious disease, as assessed by the investigator, within 2 weeks prior to the first dose.
•Current active tuberculosis based on QuantiFERON-TB Gold test.
•Positive hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antibodies at screening.
•Electrocardiogram abnormalities at screening or check-in.
•Smoking of >10 cigarettes per day, on average, within the last 3 months.

研究组 & 干预措施

Single ascending dose Cohort A

Experimental

Single dose of LEO 142397 or placebo.

干预措施: Placebo (Drug)

Single ascending dose Cohort A

Experimental

Single dose of LEO 142397 or placebo.

干预措施: LEO 142397 (Drug)

Single ascending dose Cohort H

Experimental

Single dose of LEO 142397 or placebo - tentative, female-only cohort (to be included only if the number of women recruited in the remaining cohorts is insufficient to assess the pharmacokinetics of LEO 142397 in women). Dose level ≥ that in Cohort C and ≤ that in Cohort D.

干预措施: LEO 142397 (Drug)

Single ascending dose Cohort B

Experimental

Single dose of LEO 142397 or placebo.

干预措施: LEO 142397 (Drug)

Single ascending dose Cohort B

Experimental

Single dose of LEO 142397 or placebo.

干预措施: Placebo (Drug)

Single ascending dose Cohort C

Experimental

2 single doses, separated by a washout of ≥7 days.

干预措施: LEO 142397 (Drug)

Single ascending dose Cohort C

Experimental

2 single doses, separated by a washout of ≥7 days.

干预措施: Placebo (Drug)

Single ascending dose Cohort D

Experimental

2 single doses, separated by a washout of ≥7 days.

干预措施: LEO 142397 (Drug)

Single ascending dose Cohort D

Experimental

2 single doses, separated by a washout of ≥7 days.

干预措施: Placebo (Drug)

Single ascending dose Cohort E

Experimental

Single dose of LEO 142397 or placebo.

干预措施: LEO 142397 (Drug)

Single ascending dose Cohort E

Experimental

Single dose of LEO 142397 or placebo.

干预措施: Placebo (Drug)

Single ascending dose Cohort F

Experimental

Single dose of LEO 142397 or placebo.

干预措施: LEO 142397 (Drug)

Single ascending dose Cohort F

Experimental

Single dose of LEO 142397 or placebo.

干预措施: Placebo (Drug)

Single ascending dose Cohort G

Experimental

Single dose of LEO 142397 or placebo.

干预措施: LEO 142397 (Drug)

Single ascending dose Cohort G

Experimental

Single dose of LEO 142397 or placebo.

干预措施: Placebo (Drug)

Single ascending dose Cohort H

Experimental

干预措施: Placebo (Drug)