A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TVB-3567 in Healthy Participants With or Without Acne and to Assess the Effect of Food in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Part A - Incidence of adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
This is a 4-part study. Part A will be a randomized, double-blind, placebo-controlled investigation of single ascending doses (SAD) to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) biomarkers of TVB-3567 administered orally in healthy participants. Part B will be a randomized, open-label, 2-way crossover investigation to assess the effect of food on a single dose TVB-3567 administered orally in healthy participants. Parts C and D will be randomized, double-blind, placebo-controlled investigations of multiple ascending doses (MAD) to assess the safety, tolerability, PK, and PD/biomarkers of TVB-3567 administered orally in healthy participants without and with moderate to severe acne, respectively.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Participants (Parts A, B and C)
- •Healthy, adult, male or female 18-55 years of age
- •Body mass index (BMI) ≥18.0 and ≤32.0 kg/m2
- •Medically healthy with no clinically significant medical history
- •Understands the study procedures in the informed consent form (ICF) and willing and able to comply with the protocol
- •Healthy Participants with Acne (Part D only)
- •Participants must meet all of the above criteria, as well as the following inclusion criteria to be eligible for participation in the study:
- •BMI ≥18.0 and ≤37.0 kg/m
- •Must be diagnosed with moderate to severe acne vulgaris
排除标准
- •Healthy Participants (Parts A, B and C)
- •History or presence of clinically significant medical or psychiatric condition or disease
- •History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds including over the counter acne products.
- •Has a clinically significant ophthalmic examination finding
- •Female participant of childbearing potential
- •Unable to refrain from or anticipates the use of:
- •Any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements
- •Any topical anti-acne treatment on the face
- •Any drugs known to be moderate or strong inducers of CYP3A4 enzymes, BCRP, and/or P gp, including St. John's Wort, beginning 28 days prior to the first dosing.
- •Part C only: Any previous tretinoin treatments, including tazarotene, adapalene, isotretinoin, and all-trans retinoic acid.
- •Healthy Participants with Acne (Part D only)
- •Participants must not be enrolled if they do not meet any of the above criteria, as well as the following exclusion criteria:
- •Unable to refrain from or anticipates the use of:
- •Any previous tretinoin treatments, including tazarotene, adapalene, isotretinoin, and all trans retinoic acid.
- •Photoelectric therapy, dermabrasion, or chemical peeling
- •Intra-articular and systemic corticosteroid therapy
- •Significant skin diseases
研究组 & 干预措施
Part A (SAD in Healthy Participants)
干预措施: TVB-3567 (Drug)
Part B (Food Effect)
干预措施: TVB-3567 (Drug)
Part C (MAD in Healthy Participants)
干预措施: TVB-3567 (Drug)
Part D (MAD in Acne Participants)
干预措施: TVB-3567 (Drug)
Part A (SAD in Healthy Participants)
干预措施: Placebo (Drug)
Part C (MAD in Healthy Participants)
干预措施: Placebo (Drug)
Part D (MAD in Acne Participants)
干预措施: Placebo (Drug)
结局指标
主要结局
Part A - Incidence of adverse events (AEs) and serious adverse events (SAEs)
时间窗: Baseline to 7 to 8 days after dosing
Part B - Plasma AUC0-t in fasted and fed conditions
时间窗: Baseline to Day 4
Area under the concentration-time curve from time zero until the last observed concentration
Part B - Plasma AUC0-inf in fasted and fed conditions
时间窗: Baseline to Day 4
Area under the concentration-time curve from time zero to infinity
Part B - Plasma Cmax in fasted and fed conditions
时间窗: Baseline to Day 4
Maximum concentration measurement in plasma
Part B - Incidence of adverse events (AEs) and serious adverse events (SAEs) under fasted and fed conditions
时间窗: Baseline to 7 to 8 days after dosing
Part C - Incidence of adverse events (AEs) and serious adverse events (SAEs)
时间窗: Baseline to 13 to 15 days after the last dose
Part D - Incidence of adverse events (AEs) and serious adverse events (SAEs)
时间窗: Baseline to 13 to 15 days after the last dose
次要结局
未报告次要终点