NCT06086613已完成1 期
A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AGA2115 in Adult Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-emergent adverse events (TEAEs)
研究概览
简要总结
To understand if AGA2115 is safe and well tolerated in healthy adult volunteers.
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)
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
- •Healthy men and women ≥18 to ≤65 years old.
- •Vitamin D sufficiency (≥20 ng/mL (50 nmol/L) and agree to taking Calcium and Vitamin D supplements during the trial.
排除标准
- •History of myocardial infarction or stroke (or other cardiovascular associated event deemed significant by investigator) within 12 months prior to Day
- •Malignancy within the last 5 years (basal cell carcinoma and squamous cell carcinoma that have been excised with no recurrence within the last 5 years is allowed).
- •Hyper- or hypocalcemia.
- •Known sensitivity to mammalian-derived drug preparations and/or any biologics.
- •Pregnant or breastfeeding or planning to become pregnant (self or partner) at any time during the study.
- •The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
研究组 & 干预措施
AGA2115
Experimental
In Part A, up to 6 single ascending dose cohorts.
In Part B, up to 3 multiple ascending dose cohorts.
干预措施: AGA2115 (Drug)
Placebo
Placebo Comparator
Participants will receive matching placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with treatment-emergent adverse events (TEAEs)
时间窗: Day 1 to up to end of study (approximately 85 days in Part A, approximately 169 days in Part B)
Clinically significant changes in clinical laboratory tests, vital signs, and 12-lead electrocardiograms (ECGs) will be recorded as TEAEs.
次要结局
- Area under the concentration time curve (AUC) of AGA2115(Day 1 to up to end of study (approximately 85 days in Part A, approximately 169 days in Part B))
- Time to maximum observed concentration (Tmax) of AGA2115(Day 1 to up to end of study (approximately 85 days in Part A, approximately 169 days in Part B))
- Maximum observed concentration (Cmax) of AGA2115(Day 1 to up to end of study (approximately 85 days in Part A, approximately 169 days in Part B))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A First-in-Human Study Evaluating AGA2118 in Men and Postmenopausal WomenOsteoporosisNCT05225857Angitia Biopharmaceuticals90
已完成
1 期
Single and Multiple Ascending Dose Study and Food Effect Study for AG181Healthy VolunteersNCT06286033Agios Pharmaceuticals, Inc.88
已完成
1 期
A Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011 in Ulcerative ColitisModerately Active Ulcerative ColitisNCT00729872ActoGeniX N.V.60
终止
1 期
A Study of ALG-020572 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Doses in Healthy Volunteers and Multiple Doses in CHB SubjectsChronic Hepatitis BNCT05001022Aligos Therapeutics40
已完成
1 期
A Study of ALG-000184 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB SubjectsChronic Hepatitis BNCT04536337Aligos Therapeutics165