A Double-blind, Placebo Controlled, Randomised Trial to Compare the Efficacy of 250ng and 500ng RN1006 (a New Formulation of Avotermin) and 250ng and 500ng Juvista (Standard Avotermin Formulation), in the Improvement of Scar Appearance in Healthy Volunteer Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Global scar comparison scale
研究概览
简要总结
RN1006 has been developed as a stabilized formulation of avotermin which, when dosed once in pre-clinical studies in animals, has shown comparable scar improvement efficacy to the standard twice-dosed Juvista formulation. The aim of this trial is to investigate the efficacy of RN1006 compared to Juvista in a human volunteer model
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females aged 18-85 years who have given written informed consent
- •Subjects with a body mass index within range 18-35 kg/m2
- •Subjects with clinically acceptable results for the laboratory tests specified in the trial protocol
- •Female subjects using a highly effective method (S) of contraception
排除标准
- •Subjects who have a history of keloid scarring, surgery within one year of the first dosing area
- •Subjects who have current scars, tattoos, birthmarks, mole within 3 cm of the area to be excised
- •Subjects with any clinically significant medical condition or history of any condition which may impair wound healing
研究组 & 干预措施
1a
250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then a further 250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose.
干预措施: Juvista (Avotermin) (Drug)
1a
250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then a further 250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose.
干预措施: Placebo (Drug)
1b
250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then a further 250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose.
干预措施: RN1006 (Avotermin) (Drug)
1b
250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then a further 250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose.
干预措施: Placebo (Drug)
1c
250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure.
干预措施: RN1006 (Avotermin) (Drug)
1c
250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure.
干预措施: Placebo (Drug)
1d
500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure.
干预措施: RN1006 (Avotermin) (Drug)
1d
500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure.
干预措施: Placebo (Drug)
2a
250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then 250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose.
干预措施: Juvista (Avotermin) (Drug)
2a
250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then 250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose.
干预措施: Placebo (Drug)
2b
500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure.
干预措施: Juvista (Avotermin) (Drug)
2b
500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure.
干预措施: Placebo (Drug)
2c
500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then a further 500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose.
干预措施: Juvista (Avotermin) (Drug)
2c
500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then a further 500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose.
干预措施: Placebo (Drug)
2d
500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then 500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose (i.e. two doses in total).
干预措施: RN1006 (Avotermin) (Drug)
2d
500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then 500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose (i.e. two doses in total).
干预措施: Placebo (Drug)
结局指标
主要结局
Global scar comparison scale
时间窗: 12 months
次要结局
- Adverse event incidence including specific assessment of local tolerability at the treated wound site(12 months)