NCT06826196 · Aldena Therapeutics
A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ALD-102 Solution in Subjects With Alopecia Areata
What this study is about
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).
View original scientific description
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).
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
Primary outcome measures
Number of participants with treatment-related adverse effects (AEs) and severe adverse effects (SAEs) as assessed by CTCAE, and injection site reactions (ISRs), evaluated by local tolerability assessments and numerical scales.
Time frame: Clinical assessments during treatment and follow up period for a total of 24 weeks.
AEs assessed by guidelines outlined in CTCAE at baseline, during treatment and follow-up periods. ISRs assessed by local tolerability assessments (LTA), including evaluation by the investigator of erythema, swelling, induration, and bruising, and evaluation by the subject of burning, stinging and itching. Grading using a 4-point scale of 0 to 3 (non, mild, moderate, severe) will be used to assess each sign. Pain at each treatment area will also be assessed using a pain numerical rating scale (NRS). Subjects will be asked to assign a numerical score representing the average pain intensity on a scale of 0 to 10, experienced during and after product administration. The LTA will be done during injection days and during the follow up period.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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. Subjects with AA lesion(s) that can accommodate for 2 separate treatment areas large enough to receive 20 injections each (Cohort 1) or to receive 40 injections each (Cohorts 2-4). The 2 treatment areas must be clinically similar as per investigator's judgment, ≥ 6 cm apart, and can be located on the same AA lesion or on 2 different AA lesions. 6. Duration of current episode of hair loss at the treatment areas \> 6 months but \< 5 years at screening and Day 1, along with investigators' assessment that hair regrowth is possible. Total duration of current episode of hair loss outside of treatment areas and total durati
Where
- Thousand Oaks, California
- West Lafayette, Indiana
- Boston, Massachusetts
- Spokane, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 4, 2026 · Source of record for eligibility and locations