A Phase 1, Double Blind, Randomized, Placebo-Controlled First in Human Study, to Assess the Safety, Tolerability and Pharmacokinetics of BAP5191 Following Topical Application of Repeat Doses in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bacoba AG
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Temperature from baseline
研究概览
简要总结
All enrolled participants will be randomized to 3 cohorts with 8 participants each and will receive BAP5191 and placebo topically on a square of 121 cm2 each in the left and right scapula region daily for 28 days, with a 28-d safety follow-up.
The squares will be covered with a semi-occlusive patch. The doses will escalate from Cohort 1 to Cohort 2 to Cohort 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Screening
- 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 adult participants,18 to 65 years of age.
- •Women of childbearing potential (WOCBP) must agree to use a highly effective form of contraception, from at least 7 days prior to first administration to 28 days after last administration.
- •Male participants with WOCBP partner must be willing to use condoms from first IMP application to 90 days after last application.
- •Body Mass Index (BMI) between 18 and 29.9 kg/m
- •Body weight must be greater than 50 kg.
- •Clinical laboratory parameters, vital signs, pulse oximetry, and ECG within the reference range from population studies, or showing no clinically relevant deviations.
排除标准
- •Chronic use of immunosuppressants within 3 years prior to the first administration of the study drug.
- •History of prior leishmaniasis or extensive travel to endemic regions within 1 year prior to the first administration of the study drug.
- •Presence or history of severe adverse reaction to any drug, or sensitivity to components of the study medication or to adhesive bandages or tape.
- •Skin diseases, excessive hair, tattoos, pigmentation, scars or moles that could interfere with patch application and skin assessment at the site of application.
研究组 & 干预措施
Cohort 1
1 mg/mL (0.1%) BAC6027 formulation; placebo
干预措施: BAP5191 (Drug)
Cohort 2
5 mg/mL (0.5%) BAC6027 formulation; placebo
干预措施: BAP5191 (Drug)
Cohort 3
10 mg/mL (1.0%) BAC6027 formulation; placebo
干预措施: BAP5191 (Drug)
结局指标
主要结局
Temperature from baseline
时间窗: From day 0 to day 55
Change of tympanic temperature from baseline.
Local skin tolerability: dermal response score
时间窗: From day 0 to day 55
Summarized statistics of tolerability assessment based on dermal response score and other effects score. The dermal response score ranges from score 0 (better, No evidence of irritation) to score 7 (worse, Strong reaction spreading beyond test site).
Blood pressure from baseline
时间窗: From day 0 to day 55
Change of blood pressure from baseline. Systolic and diastolic blood pressure will be assessed.
Local skin tolerability: other effects score
时间窗: From day 0 to day 55
Summarized statistics of tolerability assessment based on dermal response score and other effects score. The other effects score ranges from score 0 (better, None observed) to score 4 (worse, Glazing with fissures, Film of dried serous exudates covering all or part of the patch site, Small petechial erosions and/or scabs).
General safety (number, frequency, severity, seriousness and duration of adverse events)
时间窗: From day 0 to day 55
Summarized statistics on adverse events will be reported under categories such as total adverse events, serious adverse events, treatment emerging adverse events.
Heart rate from baseline
时间窗: From day 0 to day 55
Change of pulse rate from baseline.
Respiratory rate from baseline
时间窗: From day 0 to day 55
Change of respiratory rate from baseline.
ECG parameters from baseline
时间窗: From day 0 to day 55
Change in 12-lead electrocardiogram (ECG) parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) from baseline.
次要结局
- AUC (0-∞) of BAC6027(during the procedure, day 0 - day 31)
- T1/2 of BAC6027(during the procedure, day 0 - day 31)
- Cmax of BAC6027(during the procedure, day 0 - day 31)
- Tmax of BAC6027(during the procedure, day 0 - day 31)
- AUC (0-t), of BAC6027(during the procedure, day 0 - day 31)
- AUC of BAC6027(during the procedure, day 0 - day 31)