NCT07271693招募中1 期
A Phase I, Randomized, Investigator/Participant-blind, Parallel-group, Placebo-controlled, Single and Multiple Ascending Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7806881 in Healthy Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- MAD Part: Number of Participants With DLAEs
研究概览
简要总结
The main purpose of this study is to evaluate the safety and tolerability of single and multiple ascending doses of RO7806881 in healthy participants.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be males or females who are overtly healthy as determined by medical evaluation
- •Participants must have body weight (BW) ≥ 40 kilograms (kg) (not applicable to Cohort A9) and body mass index (BMI) within the range 18-32 kilograms per square meter (kg/m^2) (inclusive)
- •Inclusion Criteria Specific to Cohort A9 (East Asian Cohort):
- •Must be of ethnic Chinese, Korean, or Japanese origin
- •Must have a BW >35 kg and BMI within the range 18-32 kg/m2 (inclusive)
排除标准
- •Pregnancy, breastfeeding, or intention to become pregnant during the study or within 6 months after the final dose of study treatment
- •History of any clinically significant autoimmune, gastrointestinal, renal, hepatic, pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological, or allergic disease; metabolic disorder; cancer or cirrhosis
- •Latent tuberculosis (TB) or potentially active TB
- •Any major illness within 1 month before the screening examination or any febrile illness within 1 week prior to the screening visit and up to first dose administration
- •Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study
- •History of hypersensitivity to biologic agents or any of the excipients in the formulation, or other allergy that contraindicates participation in the study
- •Live vaccines within 1 month of the first screening visit or during the screening period
- •Non-live vaccines within 2 weeks prior to dosing
- •Previous exposure to RO7806881
- •Positive hepatitis C virus (HCV) antibody test result
- •Positive test results for hepatitis B infection
- •Positive human immunodeficiency virus (HIV) antibody test result
- •Positive test result consistent with cytomegalovirus (CMV) or Epstein-Barr virus (EBV)
研究组 & 干预措施
RO7806881: Multiple Ascending Doses (MAD)
Experimental
Participants will receive multiple doses of RO7806881, at 4 dose levels across 4 different cohorts (B1-B4), per the predefined dosing regimen.
干预措施: RO7806881 (Drug)
RO7806881: Single Ascending Dose (SAD)
Experimental
Participants will receive single doses of RO7806881, at 8 dose levels across 9 different cohorts (A1-A9) including one optional SAD cohort of East Asian participants (Cohort A9).
干预措施: RO7806881 (Drug)
Placebo: SAD
Placebo Comparator
Participants will receive single doses of placebo, matched to each of the 8 dose levels of RO7806881.
干预措施: Placebo (Drug)
Placebo: MAD
Placebo Comparator
Participants will receive multiple doses of placebo, matched to each of the 4 dose levels of RO7806881, per the predefined dosing regimen.
干预措施: Placebo (Drug)
结局指标
主要结局
MAD Part: Number of Participants With DLAEs
时间窗: Up to Day 162
MAD Part: Number of Participants With AEs
时间窗: Up to Day 162
SAD Part: Number of Participants With Adverse Events (AEs)
时间窗: Up to Day 127
SAD Part: Number of Participants With Dose-limiting Adverse Events (DLAEs)
时间窗: Up to Day 127
次要结局
- SAD and MAD Parts: Absolute Bioavailability of RO7806881(SAD: Up to Day 127; MAD: Up to Day 162)
- SAD and MAD Parts: Dose Proportionality for AUC(SAD: Up to Day 127; MAD: Up to Day 162)
- SAD and MAD Parts: Apparent Total Body Clearance (CL/F) of RO7806881(SAD: Up to Day 127; MAD: Up to Day 162)
- MAD Part: Accumulation Ratio (Racc) of RO7806881(Up to Day 162)
- SAD and MAD Parts: Maximum Concentration (Cmax) of RO7806881(SAD: Up to Day 127; MAD: Up to Day 162)
- SAD and MAD Parts: Minimum Concentration (Cmin) of RO7806881(SAD: Up to Day 127; MAD: Up to Day 162)
- SAD and MAD Parts: Area Under the Curve (AUC) From the Last Time of Dosing to the Last Measurable Concentration (AUClast) of RO7806881(SAD: Up to Day 127; MAD: Up to Day 162)
- SAD and MAD Parts: Volume of Distribution at Steady-state Conditions (Vss) of RO7806881(SAD: Up to Day 127; MAD: Up to Day 162)
- SAD and MAD Parts: Dose Proportionality for Cmax(SAD: Up to Day 127; MAD: Up to Day 162)
- SAD and MAD Parts: Serum Concentration of RO7806881(SAD: Up to Day 127; MAD: Up to Day 162)
研究者
研究点 (1)
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