ACTRN12621000255886已完成1 期
A Double-Blind, Randomised, Vehicle-Controlled Phase 1b Study to Evaluate the Safety and Pharmacokinetics of GDD3898 Topical Gel in Healthy Volunteers
ipidio Pharmaceuticals Australia Pty Ltd.0 个研究点目标入组 16 人开始时间: 2021年3月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Subjects are required to meet the following criteria in order to be included in the study:
- •1. Male or female 18-65 years of age
- •2. BMI between 18.5 and 30 inclusive at screening
- •3. Women of childbearing potential are required to use a protocol-approved highly effective contraceptive method for at least 4 weeks prior to Day 1 until at least 4 weeks after the last application.
- •4. Males with female partners of childbearing potential must use reliable forms of contraception form screening to 30 days after the end of treatment.
排除标准
- •Subjects with the following characteristics will be excluded from the study:
- •1. Females who are breastfeeding, pregnant, or planning to become pregnant
- •2. History of skin disease or presence of skin condition and prior skin treatment on the arms such as laser hair removal that, in the opinion of the Investigator, would interfere with the study assessments.
- •3. Presence of scars, birthmarks, tattoos, or excessive hair at the application site(s) that would impede the assessment of local tolerability assessments
- •4. History of or positive results for hepatitis B, hepatitis C, HIV
- •5. History of cancer or lymphoproliferative disease within 5 years prior to Day 1
- •6. Major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study
- •7. History of clinically significant drug or alcohol abuse in the year prior to Screening, or positive urine drug or alcohol breath test
- •8. Current use of nicotine-containing products within 3 months of first application of study drug, or positive urine cotinine test
- •9. Blood donation within 60 days prior to dosing or plasma donation within 14 days of dosing
- •10. Worn contact lens within 10 days prior to screening and prior to the first dose of study drug throughout the period of dose application and until the last PK blood draw is collected
- •11. Corneal or eyelid surgery, such as eyelid repair, reconstruction, and/or lifts, corneal transplantation, LASIK, photorefractive keratectomy, and/or radial keratotomy surgery and/or has a history or presence of dry eye
- •12. Pyrexia, cough, malaise or any other symptoms or signs consistent with SARS- CoV2 viral infection at any time within 14 days prior to screening
研究者
相似试验
已完成
1 期
A Double-Blind, Randomised, Vehicle-Controlled Phase 1b Study to Evaluate the Safety and Pharmacokinetics of GDD3898 Topical Gel in Over-weight or Obese Subjects with Presumed Nonalcoholic Fatty Liver Disease (NAFLD)Nonalcoholic fatty liver diseaseObesityACTRN12622000171718ipidio Pharmaceuticals Australia Pty Ltd.21
进行中（未招募）
1 期
INM-755 cream for patients with EB.MedDRA version: 20.0Level: PTClassification code 10014989Term: Epidermolysis bullosaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEpidermolysis bullosaEUCTR2021-000214-42-GRInMed Pharmaceuticals Inc.20
进行中（未招募）
1 期
INM-755 cream for patients with EB.MedDRA version: 20.0Level: PTClassification code 10014989Term: Epidermolysis bullosaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEpidermolysis bullosaEUCTR2021-000214-42-FRInMed Pharmaceuticals Inc.20
进行中（未招募）
1 期
INM-755 cream for patients with EB.Epidermolysis bullosaEUCTR2021-000214-42-ESInMed Pharmaceuticals Inc.20
进行中（未招募）
1 期
INM-755 cream for patients with EB.MedDRA version: 20.0Level: PTClassification code 10014989Term: Epidermolysis bullosaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEpidermolysis bullosaEUCTR2021-000214-42-DEInMed Pharmaceuticals Inc.20