2023-505907-21-00招募中2 期
A Mechanistic Study to Evaluate Impact of Afamelanotide in Aqueous Solution on Ultraviolet Radiation-Induced DNA Damage and DNA Repair Capacity in Healthy Volunteers
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The changes in UV photoproducts from pre to post afamelanotide in UVR exposed skin and in non-irradiated skin.
研究概览
简要总结
Evaluate the impact of afamelanotide in aqueous solution on total UVR-induced direct DNA damage in healthy human skin.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Healthy adult males and females aged between 18 and 45 years (inclusive) (heart rate between 50 and 90 bpm, blood pressure below 120/80 mm Hg and above 90/60 mm Hg and normal renal and hepatic function as determined through laboratory testing)
- •Willing and able to comply with the conditions specified in the protocol and study procedures, in the opinion of the Investigator.
- •Free of significant abnormal findings as determined during the screening procedure by medical history, laboratory testing and vital signs.
- •Body Mass Index (BMI) between 18 and 30 kg/m
- •No history of drug abuse, licit or illicit assessed through medical history review and a urine drug screening test
- •Agree not to use any non-prescribed medications.
- •Willing to take precautions to prevent pregnancy with their partner.
- •Able and willing to follow the protocol requirements.
- •Able to understand and provide written Informed Consent prior to the performance of any study-specific procedure.
排除标准
- •Any personal or family history of melanoma or personal history of dysplastic nevus syndrome.
- •Females of child-bearing potential not using adequate contraceptive measures or a lifestyle excluding pregnancy.
- •Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures.
- •Taking medications that are known photosensitisers.
- •Individual history of basal cell carcinoma, squamous cell carcinoma (inclusive carcinoma in situ e.g. Bowen’s disease), Merkel cell carcinoma or other malignant or premalignant skin lesions.
- •Regularly drinks more than four units of alcohol per day.
- •Participation in any clinical study during the six weeks before Screening.
- •Any significant illness prior to the study screening period.
- •Solarium use/sunbathing prior to study involvement and throughout the duration of the study.
- •Not suitable for study participation in the opinion of the Investigator.
- •Known allergy or anaphylaxis to adrenocorticotropic hormone (ACTH) or melanocortins or any of the excipients listed in the Investigator’s Brochure.
- •Any medical condition which may interfere with the study protocol.
- •Female who is pregnant or lactating.
结局指标
主要结局
The changes in UV photoproducts from pre to post afamelanotide in UVR exposed skin and in non-irradiated skin.
The changes in UV photoproducts from pre to post afamelanotide in UVR exposed skin and in non-irradiated skin.
次要结局
未报告次要终点
研究者
Head of clinical operations
Scientific
Clinuvel Europe Limited
研究点 (1)
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