A PhaseⅠRandomised, Double-blind, Placebo-controlled, Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Characteristics of the Oral Topical Use of GB001 Recombinant Peptide Spray in Chinese Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This trial is conducted in China. The aim of this clinical trial is to assess the safety , tolerability and pharmacokinetics profiles of GB001 by single ascending dose and multiple ascending doses in healthy subjects after topical buccal delivery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Healthy males or females aged 18 to 45 years, with a body mass index(BMI) 19-26kg/m2 and body weight no less than 45 kg (female) or 50 kg (male).
- •The results in the screening examinations (including general physical examination, vital signs, laboratory examinations, electrocardiogram, chest radiograph, etc.) are in the normal range, or are abnormal without clinical significance assessed by the investigator.
- •Subjects and their sexual partners agree to take effective contraceptive measures during the study period and at least 3 days after the end of the study.
- •Understanding and willing to comply strictly with the clinical trial protocol, complete all test procedures required in this trial, understand and sign informed consent form.
排除标准
- •Those allergic to GB001 peptide or any other drugs, or suffered from allergic disease or allergic constitution.
- •Any obvious clinical symptoms or abnormal test results with clinical significance suggested organ or system illness, unsuitable for inclusion in this trial in the investigator's judgement.
- •Subjects has obvious oral lesions or diseases, such as erosion of oral mucosa, ulcer or obvious periodontitis.
- •The weekly alcohol intake in 90 days before screening is more than 21 units (male) and more than 14 units (female) , or the subject is unwilling to stop drinking whenever required for the trial procedure.
- •Subject who smoke more than 10 cigarettes per day or is unwilling to stop smoking whenever required for the trial procedure.
- •Subject with a history of drug abuse, or those with positive urine screening test for drug abuse.
- •Subject who use of any other drugs within 30 days prior to screening, including prescription drugs, non-prescription drugs, biologicals, vitamins, minerals and nutritional supplements.
- •Blood loss or blood donation more than 400 mL within 90 days prior to screening.
- •Received major surgery within 90 days prior to screening, or participated in any other drug/device clinical trial.
- •Pregnant or lactating women; or female subject of childbearing age have a positive serum pregnancy test result during the screening.
- •Subject with dizzy needle or difficulty in venous blood collection.
- •Subject unsuitable for the trial in the judgement of the investigator.
研究组 & 干预措施
Single dose-escalation of GB001 recombinant peptide spray
Each subject will receive one single administration of GB001 recombinant peptide. The dosage of each group is 0.054mg, 0.108mg, 0.216mg, 0.432mg and 0.864mg, respectively.
干预措施: GB001 recombinant peptide spray (Drug)
Single dose-escalation of GB001 recombinant peptide spray
Each subject will receive one single administration of GB001 recombinant peptide. The dosage of each group is 0.054mg, 0.108mg, 0.216mg, 0.432mg and 0.864mg, respectively.
干预措施: Placebo (Drug)
Oral retention time test for a single dose
Each subject will receive one single administration of GB001 recombinant peptide. The dosage of the group is 0.108mg.
干预措施: GB001 recombinant peptide spray (Drug)
Multiple Ascending Dose of GB001 recombinant peptide spray
Each subject will be dosed with oral spray of GB001 recombinant peptide ten times per day for four days. GB001 recombinant peptide will be administrated, and the dosage of each group is 0.108mg, 0.216mg and 0.432mg, respectively.
干预措施: GB001 recombinant peptide spray (Drug)
Multiple Ascending Dose of GB001 recombinant peptide spray
Each subject will be dosed with oral spray of GB001 recombinant peptide ten times per day for four days. GB001 recombinant peptide will be administrated, and the dosage of each group is 0.108mg, 0.216mg and 0.432mg, respectively.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: Through the study completion, an average of 2 weeks
The number and the incidence of serious and non-serious adverse events observed in each treatment will be used to assess the safety and tolerability
次要结局
- Pharmacokinetics Characteristics， t½ of GB001 recombinant peptide(Up to 240 minutes after last dose)
- Pharmacokinetics Characteristics , Tmax of GB001 recombinant peptide(Up to 240 minutes after last dose)
- Pharmacokinetics Characteristics , AUC of GB001 recombinant peptide(Up to 240 minutes after last dose)
- Pharmacokinetics Characteristics , Cmax of GB001 recombinant peptide(Up to 240 minutes after last dose)
- Pharmacokinetics Characteristics , Vd of GB001 recombinant peptide(Up to 240 minutes after last dose)
- Pharmacokinetics Characteristics , Ctrough of GB001 recombinant peptide(Up to 240 minutes after last dose)