A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Ef
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 Sol
| Condition(s) | Alopecia Areata (AA) |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 judgement. 5. For the treatment area(s) receiving ALD-102 Solution: subject must have AA lesion(s) that can accommodate the required number of injections per cohort: 20 injections for Cohorts 1#-3# and 40 inj |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Lead sponsor | Aldena Therapeutics |
| Locations | Thousand Oaks, California, United States; West Lafayette, Indiana, United States; Boston, Massachusetts, United States; Spokane, Washington, United States; Oakville, Ontario, Canada; Montreal, Quebec, Canada (+1 more sites) |
| Start date | 2025-03-24 |
| NCT ID | NCT06826196 |
| Official listing | https://clinicaltrials.gov/study/NCT06826196 |