A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ALD-102 Solution in Subjects With Alopecia Areata
NCT06826196 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2026-03-04
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.
Conditions
- Alopecia Areata (AA)
Interventions
- DRUG
-
ALD-102 Solution
Treatment every 4 weeks for total of 8-week treatment period.
- OTHER
-
Placebo or Control
Treatment every 4 weeks for 8-week treatment period
Sponsors & Collaborators
-
Aldena Therapeutics
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-24
- Primary Completion
- 2026-10-31
- Completion
- 2026-12-31
- FDA Drug
- Yes
Countries
- United States
- Canada
Study Locations
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