A Phase 1, First-in-human Study of MORF-440 in Healthy Participants, Including Single and Multiple Ascending Dose Cohorts
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of single ascending doses of MORF-440 administered to healthy participants single-ascending dose (SAD) and maximum ascending dose (MAD) substudy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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 (BMI) within 18.0 kg/m² to 30.0 kg/m², inclusive
- •If male, meets one of the following:
- •can procreate and agree to use one of the accepted to use one of the accepted contraceptive regimens and not to donate sperm from the first study drug administration to at least 90 days after the last drug administration.
- •is unable to procreate; defined as surgically sterile (i.e., has undergone a vasectomy at least 180 days prior to the first study drug administration)
- •if female, meets one of the following:
- •is of childbearing potential and agrees to use an acceptable contraceptive method.
- •is of non-childbearing potential, defined as either:
- •Surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or
- •is in a postmenopausal state:
- •At least 1 year without menses and without an alternative medical condition prior to the screening, and follicle stimulating hormone (FSH) levels ≥ 40 mIU/mL at screening or at least 1 year without menses and without an alternative medical condition prior to the screening, follicle stimulating hormone FSH levels < 40 milli-international units per milliliter (mIU/mL) and estradiol serum level ≤150 picomole/Liter (pmol/L) at screening
排除标准
- •Female who is lactating or who is pregnant according to the pregnancy test at screening or prior to the first study drug administration, or planning to become pregnant during the study period up to 30 days after the last study drug administration
- •Nicotine intake (e.g., smoking, nicotine patch, nicotine chewing gum, chewing tobacco, electronic cigarettes) within 1 month before screening and/or inability to refrain from nicotine from screening until the end of the study
研究组 & 干预措施
Cohort A1
Participants received LY4292009 orally.
干预措施: LY4292009 (Drug)
Cohort A2
Participants received LY4292009 orally.
干预措施: LY4292009 (Drug)
Cohort A5
Participants received LY4292009 orally.
干预措施: LY4292009 (Drug)
Cohort B3
Participants received LY4292009 orally.
干预措施: LY4292009 (Drug)
Placebo
Participants receive placebo.
干预措施: Placebo (Drug)
Cohort A3
Participants received LY4292009 orally.
干预措施: LY4292009 (Drug)
Cohort A4
Participants received LY4292009 orally.
干预措施: LY4292009 (Drug)
Cohort A6 (Optional)
Participants received LY4292009 orally.
干预措施: LY4292009 (Drug)
Cohort B1
Participants received LY4292009 orally.
干预措施: LY4292009 (Drug)
Cohort B2
Participants received LY4292009 orally.
干预措施: LY4292009 (Drug)
Cohort B4 (Optional)
Participants received LY4292009 orally.
干预措施: LY4292009 (Drug)
结局指标
主要结局
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)
时间窗: Baseline to Study Completion (Up to Day 17)
Percentage of Participants with TEAEs and SAEs in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)
时间窗: Baseline to Study Completion (Up to Day 7)
Number of Participants with One or More Serious Adverse Event(s) (SAEs) in (Cohort A1-A6) and MAD (Cohort B1-B4)
时间窗: Baseline to Study Completion (Up to Day 7)
Change from Baseline in Laboratory Parameter and Vital Signs in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)
时间窗: Baseline to Study Completion (Up to Day 7)
Number of Participants with Clinically Significant Changes in Cardiovascular Evaluation in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)
时间窗: Baseline to Study Completion (Up to Day 7)
次要结局
- Pharmacokinetics (PK): Maximum Concentration (Cmax) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)(SAD Cohorts: Predose up to Day 4 Postdose)
- PK: Time to Maximum Concentration (Tmax) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)(SAD Cohorts: Predose up to Day 4 Postdose)
- PK: Area Under the Concentration Curve (AUC) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)(SAD Cohorts: Predose up to Day 4 Postdose)
- PK: Time to Half Life (T1/2) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)(SAD Cohorts: Predose up to Day 4 Postdose)
- PK: AUC From Time Zero to Infinity (AUC 0-inf) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)(SAD Cohorts: Predose up to Day 4 Postdose)
- PK: CL/F in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)(SAD Cohorts: Predose up to Day 4 Postdose)
- PK: Vd/F in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)(SAD Cohorts: Predose up to Day 4 Postdose)
- PK: Urine: Ae(total) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)(SAD Cohorts: Predose up to Day 4 Postdose)
- PK: CLR in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)(SAD Cohorts: Predose up to Day 4 Postdose)