Phase I, Pilot Study in Healthy Volunteers, to Assess the Safety and Pharmacokinetics of PCO-02, Which Active Ingredient is BPC-157, a Penta-deca-peptide From Gastric Source.
试验速览
- 阶段
- 1 期
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
Phase I clinical trial in healthy volunteers to study safety and pharmacokinetics of BPC-157, a pentadecapeptide from gastric source.
详细描述
Title: Phase I, pilot study in healthy volunteers, to assess the safety and pharmacokinetics of PCO-02, which active ingredient is BPC-157, a pentadecapeptide from gastric source.
Protocol Number: BPC-1A/B-1.2
Phase: I
Population: Healthy subjects, males or females, between 18 and 35 years of age.
Number of Sites: Single center, to be performed at Hospital Angeles, Tijuana.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both genders, between the ages of 18 and 35 years old.
- •Willing and able to provide informed consent.
- •Body Mass Index between 18.5 and 24.9 (normal)
- •Normal blood work, according to following criteria: Leucocytes >3,000; Platelets >100,000; Hemoglobin >10.0 g/dL; AST, ALT and bilirubin < 2 times UNL; Creatinine < 2 times UNL.
- •Normal ECG and chest x-rays, at the discretion of the cardiologist and radiologist, respectively.
- •Negative urine pregnancy test (Women in childbearing age, sexually active).
- •Willing to return for follow-up as required by the study.
排除标准
- •History of psychiatric condition.
- •Pregnant or lactating women.
- •Clinically significant abnormalities on the ECG.
- •Presence of medical or social conditions that, in opinion of the investigator, may prevent the proper participation of the volunteer subject in the study or in the assessment of its outcomes.
- •Presence of an active systemic infection.
- •Subjects receiving medical treatment for any medical condition, either acute or chronic.
- •Recent (< 6 months) major surgery.
- •Recent (< 1 year) alcohol abuse or illegal drug use.
研究组 & 干预措施
Intervention 1a (cohort 1)
Single dose of 1 oral tablet of PCO-02 containing 1 mg of Bepecin (12 subjects)
干预措施: Bepecin (Drug)
Intervention 1a (cohort 2)
Single dose of 3 oral tablets of PCO-02 containing 1 mg of Bepecin (12 subjects)
干预措施: Bepecin (Drug)
Intervention 1a (cohort 3)
Single dose of 6 oral tablets of PCO-02 containing 1 mg of Bepecin (12 subjects)
干预措施: Bepecin (Drug)
Control group 1a (cohort 1)
Single dose of 1 oral tablet of PCO-03 as placebo (2 subjects)
干预措施: Placebo (Drug)
Control group 1a (cohort 2)
Single dose of 3 oral tablets of PCO-03 as placebo (2 subjects)
干预措施: Placebo (Drug)
Control group 1 a (cohort 3)
Single dose of 6 oral tablets of PCO-03 as placebo by mouth (2 subjects)
干预措施: Placebo (Drug)
Intervention 1b
Multiple dose regime of 3 oral tablets of PCO-02 containing 1 mg Bepecin every 8 hours during 2 weeks (36 subjects)
干预措施: Bepecin (Drug)
Control group 1b
Multiple dose regime of 3 oral tablets of PCO-03 as placebo every 8 hours during 2 weeks (6 subjects)
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse events
时间窗: Six months
Any adverse event reported during the study.
次要结局
- Maximum plasma concentration(168 hours)
- Area under the curve(168 hours)
- Elimination half life(168 hours)
- Time to maximum plasma concentration(168 hours)