AM1030 - Single and Multiple dose study in Atopic dermatitis patients
Research type
Research Study
Full title
AM1030: A Phase I/II, Double-Blind, Placebo-Controlled, Single and Multiple Ascending (Topical) Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Patients (Male and Female) with Atopic Dermatitis
IRAS ID
163611
Contact name
Jim Bush
Contact email
Sponsor organisation
AnaMar AB
Eudract number
2014-003684-38
Research summary
Atopic Dermatitis (AD) is a type of eczema.
A chemical found in the body called 5-hydroxytryptamine may play an important role in AD. AM1030 acts by blocking the receptors on the skin where 5-hydroxytryptamine binds.
This is the first time that the Study Drug is being given to humans. All participants will be patients with AD.
Participants and study staff will not know who receives study drug or placebo although this information will be available if necessary.
This Study uses a placebo control (‘dummy’ cream); some participants will receive the active Study Drug and some will receive placebo. Which participants receive Drug or placebo will be determined randomly.
The cream will be applied from 5% of body area or up to 45% of body area (1% of body area is approximately the same size as the full flat palm of hand, including the five fingers). The areas of body where the cream will be applied to, will be decided by the Study Doctor when subjects attend the first dosing visit. Head, neck, genitalia and hands will not be treated with Study Drug or placebo.
The starting dose level will be 16 mg. Maximum dose 145 mg. Dose will be increased by increasing the area of the body that the cream is applied to.
Part A
Up to 12 subjects and they will receive different doses in 3 groups and there will be one dose for each subject.
Part B
up to 24 subjects
Multiple dosing twice daily ( 29 doses )Following administration of the Study Drug or Placebo to the first 6 subjects in Group B if no improvement in the AD, dosing for the remaining subjects may be extended to 27 days.
Part C
up to 48 subjects, up to three times daily dosing for 14 or 27 days
REC name
South Central - Berkshire Research Ethics Committee
REC reference
14/SC/1257
Date of REC Opinion
3 Oct 2014
REC opinion
Further Information Favourable Opinion