EXT608 in Human Healthy Adults; A First-in-Human, Randomized, Double-Blind, Placebo-controlled, Single Dose Escalation Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Characterize the Safety and Tolerability of EXT608
研究概览
简要总结
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose safety and tolerability study of EXT608 in healthy subjects. There will be up to 6 sequential dose escalation cohorts of 4 participants. In each cohort 3 participants will receive EXT608 and 1 participant will receive placebo.
详细描述
This is a randomized, double-blind, first-in-human, placebo-controlled single ascending dose study to study the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EXT608 in healthy adult participants.
Participants will be enrolled into 1 of up to 6 planned single dose cohorts in ascending fashion.
Each cohort will consist of 4 participants randomized to receive either EXT608 or placebo, whereby 3 will receive a single injection of EXT608 and 1 will receive matching placebo.
Up to 6 dosing cohorts are planned with no single dose escalation to exceed a 3-fold dose increment. A Data Monitoring Board will review the seven-day safety data in each cohort before authorizing the initiation of the next cohort.
A screening visit will take place within 28 days of dosing. Eligible participants for each cohort will be admitted to the Clinical Research Unit (CRU) 1 day prior to dosing and remain in the CRU through at least 72 hours after dosing for safety and PK assessments before discharge. The total confinement period will be 4 nights, unless extended for management of Adverse Events (AEs) at the discretion of the Investigator
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double (Participant, investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female between 18 and 55 years of age.
- •Body mass index between 18.5 and 32 kilogram per square meter (kg/m2), inclusive, with a body weight greater than or equal to (>=) 45 kg.
- •In general good medical health with no clinically significant or relevant abnormalities,
- •A clinical safety laboratory parameter of hemoglobin greater than (>) 11.7 gram per deciliter (g/dl) (females) or 13.1 g/dl (males) and less than (<) 16 g/dl (females) or 17.4 g/dl (males) or, if out of this range, deemed not clinically significant by the Investigator.
- •Total serum calcium (Se-Ca) within laboratory normal limits.
- •Serum parathyroid hormone (PTH) concentration within normal laboratory limits.
排除标准
- •Evidence of clinically significant (CS) neurologic, cardiovascular, pulmonary, hepatic, hematopoietic disease, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, serious allergy, allergic skin rash, or psychiatric disorder
- •History of drug abuse
- •Currently using any medication including over-the-counter (OTC), herbal or homeopathic preparations
- •Pregnant, nursing, or planning a pregnancy during the course of or within 3 months of completing this study
- •History of cancer or other malignancy, with the exception of basal cell carcinoma that has been in remission for at least 5 years
- •Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or a human immunodeficiency virus (HIV)
- •Alanine transaminase (ALT) and/or aspartate transaminase (AST) >1.5 the upper limit of normal (ULN)
- •Increased baseline risk for osteosarcoma
研究组 & 干预措施
Experimental- EXT608
Up to 6 sequential dose escalation cohorts will receive a single dose of EXT608 administered as a subcutaneous injection
干预措施: EXT608 (Drug)
Placebo comparator
Up to 6 participants will receive matching placebo administered as a subcutaneous injection
干预措施: Placebo (Other)
结局指标
主要结局
Characterize the Safety and Tolerability of EXT608
时间窗: Day 0 - Day 28
Percentage of participants with injection or infusion site reactions - edema
次要结局
- Single Dose Pharmacokinetics (PK) - Area Under the Curve (AUC)(Day 0 to Day 7)
- Single Dose PK - Cmax(0-24 hr)
- Single Dose PK - Tmax(Day 0 to Day 7)