NCT05203692已完成1 期
A Phase 1, Subjects- and Investigator-Blinded, Sponsor-Unblinded, Placebo-Controlled, Randomized, Sequential Cohort Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous and Subcutaneous Doses of DS-7011a in Healthy Subjects
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
- 80
- 试验地点
- 2
- 主要终点
- Number of Participants with Treatment-emergent Adverse Events Following Administration with DS-7011a in Healthy Participants
研究概览
简要总结
This will be the first-in-human study designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of DS-7011a in healthy participants.
详细描述
This study will assess the safety, PK, and PD properties of single ascending intravenous (IV) and subcutaneous (SC) doses of DS-7011a in healthy participants.
This study will be conducted in 3 stages:
- Stage 1 - single ascending IV dose cohorts of DS-7011a (ie, up to 6 dose levels will be assessed starting at 0.1 mg/kg);
- Stage 2 - single ascending SC cohorts of DS-7011a (ie, up to 3 dose levels centered around the estimated therapeutic dose confirmed in Stage 1 will be assessed); and
- Stage 3 - a single IV cohort of DS-7011a in healthy participants of Japanese ethnicity (ie, 1 dose level at the estimated therapeutic dose as confirmed in Stage 1 will be assessed).
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female participants 18 to 45 years of age (inclusive), with a body mass index (BMI) of 18 kg/m^2 to 30 kg/m^2 (inclusive) at Screening.
- •Participants fully vaccinated against COVID-19 per current CDC guidelines or recovered from prior SARS-CoV-2 infection.
- •All women must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -
- •Women of childbearing potential must agree to use 2 different means of nonhormonal contraceptive methods.
- •Women of non-childbearing potential must be either:
- •Surgically sterile (ie, bilateral tubal ligation or removal of both ovaries and/or uterus at least 6 months prior to dosing) or
- •Naturally postmenopausal for at least 24 consecutive months prior to dosing, spontaneous cessation of menses, with a follicle-stimulating hormone (FSH) level at Screening of ≥40 mIU/mL.
- •Men must be surgically sterile (vasectomy 3 months before the dose of study drug) or agree to use approved contraception in addition to having their female partner (if of childbearing potential) use another acceptable form of contraception at any time during the study and for a period of 90 days after the dose of the study drug.
- •Males may not donate sperm during the study for a period of 90 days
- •Participants must be in overall good health, with no history of immunological and other chronic disorders, even if in remission and not requiring treatment.
- •Confirmed Japanese ethnicity (Stage 3 only)
排除标准
- •History or current chronic lung disease including asthma, COPD, or heavy smoking of >10 pack years
- •Previous or current treatment with systemic corticosteroids or any immunosuppressive agents
- •Participants who have received a transfusion or any blood products within the last year prior to dosing
- •Participants who have made a blood donation or have had a loss of blood ≥500 mL within 56 days prior to the dose of study drug
- •Participants who consume more than 28 units of alcohol per week (1 unit of alcohol equals 1/2 pint of beer, 4 ounces of wine, or 1 ounce of spirits) or those participants who have a significant history of alcoholism or drug/chemical abuse within the last 2 years
- •Participants with positive results on tests for drugs of abuse, cotinine, or alcohol at Screening and/or Day -1
研究组 & 干预措施
DS-7011a
Experimental
Stage 1: Healthy participants who will be randomized to receive a single intravenous (IV) ascending dose of DS-7011a (starting dose 0.1 mg/kg).
Stage 2: Healthy participants who will be randomized to receive a single subcutaneous (SC) ascending dose of DS-7011a (starting dose will be centered around estimated therapeutic dose confirmed in Stage 1).
Stage 3: Healthy Japanese participants who will be randomized to receive an IV dose of DS-7011a (based on estimated therapeutic dose confirmed in Stage 1).
干预措施: DS-7011a (Drug)
Placebo
Placebo Comparator
Healthy participants who will be randomized to receive a single dose of placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Treatment-emergent Adverse Events Following Administration with DS-7011a in Healthy Participants
时间窗: Screening (Day -28 to Day -7) up to Day 57 post-dose
Treatment-emergent adverse events (TEAEs) are defined as new adverse events (AEs) that occur after the dose of study drug or as AEs that were present prior to the dose of study drug but which worsened in severity after the start of study drug.
次要结局
- Pharmacokinetic Parameter Area Under the Concentration Curve Following Administration of DS-7011a in Healthy Participants(Stage 1 and 3: Pre-dose, end of infusion (EOI), and 1, 3, 6, 12, 24, 48, and 96 hours post-EOI, Days 8, 11, 15, 22, 29, 36, and 57; Stage 2: Pre-dose, and 1, 3, 6, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose, Days 9-12, 15, 22, 29, 36, and 57)
- Pharmacokinetic Parameter Time to Reach Maximum Plasma Concentration Following Administration of DS-7011a in Healthy Participants(Stage 1 and 3: Pre-dose, end of infusion (EOI), and 1, 3, 6, 12, 24, 48, and 96 hours post-EOI, Days 8, 11, 15, 22, 29, 36, and 57; Stage 2: Pre-dose, and 1, 3, 6, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose, Days 9-12, 15, 22, 29, 36, and 57)
- Pharmacokinetic Parameter Maximum Concentration Following Administration of DS-7011a in Healthy Participants(Stage 1 and 3: Pre-dose, end of infusion (EOI), and 1, 3, 6, 12, 24, 48, and 96 hours post-EOI, Days 8, 11, 15, 22, 29, 36, and 57; Stage 2: Pre-dose, and 1, 3, 6, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose, Days 9-12, 15, 22, 29, 36, and 57)
- Mean Interleukin (IL)-6 Levels Following Administration of DS-7011a in Healthy Participants(Stage 1 and 3: Pre-dose, end of infusion (EOI), and 1, 3, 6, 12, 24, 48, and 96 hours post-EOI, Days 8, 11, 15, 22, 29, 36, and 57; Stage 2: Pre-dose, and 1, 3, 6, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose, Days 9-12, 15, 22, 29, 36, and 57)
- Proportion of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Proportion of Participants Who Have Treatment-emergent ADA(Pre-dose (Day 1) up to Day 57 post-dose)
- Pharmacokinetic Parameter Terminal Half-life Following Administration of DS-7011a in Healthy Participants(Stage 1 and 3: Pre-dose, end of infusion (EOI), and 1, 3, 6, 12, 24, 48, and 96 hours post-EOI, Days 8, 11, 15, 22, 29, 36, and 57; Stage 2: Pre-dose, and 1, 3, 6, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose, Days 9-12, 15, 22, 29, 36, and 57)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
A First in Human Study to Evaluate Safety, Tolerability, and Pharmacology of PF-06826647 in Healthy Subjects and Subjects With Plaque PsoriasisPlaque PsoriasisNCT03210961Pfizer109
Unknown
1 期
Safety, Pharmacokinetics and Efficacy Study of Bisthianostat in Refractory or Recurrent Multiple Myeloma PatientsRefractory Multiple MyelomaRecurrent Multiple MyelomaNCT03618602Shanghai Theorion Pharmaceutical Co Ltd.30
已完成
1 期
First-in-Human Dose Escalation Study of M201-A in Healthy Japanese SubjectsHealthy VolunteersNCT03055403Yuji KUMAGAI40
招募中
1 期
JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid TumorsAdvanced Solid TumorMetastatic Solid TumorNCT06108050Jazz Pharmaceuticals177
已完成
1 期
Clinical Trial to Evaluate the Safety of RQ-01 in SARS-CoV-2 Positive SubjectsCOVID-19Infectious DiseaseSymptomatic COVID-19 Infection Laboratory-ConfirmedSARS CoV 2 InfectionNCT06063330Red Queen Therapeutics, Inc.66