The goal of this first-in-human clinical trial is to learn if ALD-102 Solution is safe and well tolerated following injections in the scalp in subjects with alopecia areata. The study will also learn about the effect of ALD-102 on hair regrowth in treatment areas. The researchers will compare the effects of ALD-102 Solution (drug) to placebo (saline solution that contains no drug) or an untreated area. Study participants will have treatment areas selected on the scalp to receive ALD-102 Solution (drug), placebo (saline solution) or to remain untreated. Injections will occur once every 4 weeks for a treatment period of 8 weeks.
Male or female subject aged 18 to 55 years, inclusive, at the time of informed consent.
Subject has a body mass index (BMI) between 18.0-35.0 kg/m2, inclusive, at screening.
Subject has a body weight ≥ 50 kg, inclusive, at screening.
Subject has a clinically confirmed diagnosis of AA at screening visit, based on investigator's judgement.
Very severe AA, defined by SALT score ≥ 95 at screening and/or Day 1, including alopecia universalis and alopecia totalis.
Presence of another form of alopecia (eg, androgenetic alopecia [AGA], traction and scarring alopecia, telogen effluvium).
Presence of diffuse type of AA. Note: Subjects with presence of ophiasis or siapho patterns of AA are allowed.
History or presence of hair transplants.