48
Participants
Start Date
February 1, 2021
Primary Completion Date
June 30, 2022
Study Completion Date
June 30, 2022
5-Aminolevulinic Acid hydrochloride (5-ALA)
5-ALA: supplied for oral administration as a dark green, opaque, size 0, hypromellose (HPMC) capsule containing drug alone at a dosage strength of 75mg (58.7mg as 5-ALA). There are no excipients.
Placebo
Supplied for oral administration as a dark green, opaque, size 0, HPMC capsule containing 125mg lactose. The capsule shells are of non-animal origin, and are comprised of HPMC, titanium dioxide, and a copper complex of chlorophyllins.
Sodium ferrous citrate (SFC)
SFC: supplied for oral administration as a dark green, opaque, size 0, HPMC capsule containing drug alone at a dosage strength 118mg (12.5mg as Fe). There are no excipients.
John Radcliffe Hospital, Oxford
Collaborators (1)
SBI Pharmaceuticals Co, Ltd.
INDUSTRY
Emerald Clinical Inc.
INDUSTRY
University of Oxford
OTHER