Aldena Therapeutics
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.
Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria, either at the screening and Day 1 visits or only at 1 of the specified visits (screening or Day 1) as noted in the criterion: 1. Male or female subject aged 18 to 55 years, inclusive, at the time of informed consent. 2. Subject has a body mass index (BMI) between 18.0-35.0 kg/m2, inclusive, at screening. 3. Subject has a body weight ≥ 50 kg, inclusive, at screening. 4. Subject has a clinically confirmed diagnosis of AA at screening visit, based on investigator's judgem…
Treatment every 4 weeks for total of 8-week treatment period.
Treatment every 4 weeks for 8-week treatment period