NCT06826196

A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ALD-102 Solution in Subjects With Alopecia Areata

A Phase 1B/2A, Intraindividual Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ALD-102 Solution for Intradermal Injection in Subjects With Alopecia Areata

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Aldena Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2025-03-24
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2025-02-13
• Last updated: 2026-03-04

Locations

7 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study