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Antifungal Agent

Ciclopirox Olamine Oral for Side Effects

Phase 1
Recruiting
Research Sponsored by Atlas Molecular Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy male or female subjects 18 to 65 years of age, inclusive
Body mass index (BMI) within the range of 18.0 to 33.0 kg/m2, inclusive, and a minimum weight of at least 50.0 and maximum weight of 100.0 kg at Screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3.5 months, with up to 66 days per participant
Awards & highlights

Study Summary

This trial tests a drug's safety, how it affects the body, and how it is absorbed in healthy people.

Who is the study for?
Healthy adults aged 18-65, with a BMI of 18.0 to 33.0 and weight between 50-100 kg can join this trial. They must have good kidney function, not be pregnant or planning pregnancy soon, and agree to use two forms of contraception. People with significant health issues, recent drug/alcohol/tobacco use, or taking certain medications are excluded.Check my eligibility
What is being tested?
The study is testing the safety and how the body processes ATL-001 (ciclopirox olamine), compared to a placebo in healthy volunteers. Participants will receive either the actual drug or an inactive substance without knowing which one they get.See study design
What are the potential side effects?
Since ATL-001 is being tested for safety, potential side effects aren't fully known yet but may include reactions at the site of administration, general discomforts like headaches or nausea, allergic reactions or other unforeseen issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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My BMI is between 18.0 and 33.0, and my weight is between 50.0 and 100.0 kg.
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I am not pregnant.
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I am using reliable birth control methods and will continue for 1 month after the study.
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I am using two reliable birth control methods and will continue for 1 month after the last drug dose.
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I am a woman not able to bear children, either due to menopause for at least 2 years or having had surgery to remove my uterus and/or ovaries.
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I am between 18 and 65 years old.
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I am female and my pregnancy test is negative.
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I am a man who can father children and agree to use two forms of birth control during and for 1 month after the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3.5 months, with up to 66 days per participant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3.5 months, with up to 66 days per participant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events (AEs)
Secondary outcome measures
Derived pharmacokinetic parameters for ATL-001

Trial Design

5Treatment groups
Experimental Treatment
Group I: ATL-001 4 mg/kg vs PlaceboExperimental Treatment2 Interventions
Cohort 5: ATL-001 at 4 mg/kg or Placebo (depending on randomization) will be administered during 5 days
Group II: ATL-001 2 mg/kg vs PlaceboExperimental Treatment2 Interventions
Cohort 4: ATL-001 at 2 mg/kg or Placebo (depending on randomization) will be administered during 5 days
Group III: ATL-001 1 mg/kg vs PlaceboExperimental Treatment2 Interventions
Cohort 3: ATL-001 at 1 mg/kg or Placebo (depending on randomization) will be administered during 5 days
Group IV: ATL-001 0.5 mg/kg vs PlaceboExperimental Treatment2 Interventions
Cohort 2: ATL-001 at 0.5 mg/kg or Placebo (depending on randomization) will be administered during 5 days
Group V: ATL-001 0.2 mg/kg vs PlaceboExperimental Treatment2 Interventions
Cohort 1: ATL-001 at 0.2 mg/kg or Placebo (depending on randomization) will be administered during 5 days

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Atlas Molecular PharmaLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical intervention have regulatory authorization?

"A rating of '1' was assigned to this intervention because it is currently in the first phase, which implies that there is minimal data demonstrating its safety and efficacy."

Answered by AI

Does this research encompass applicants aged 18 and older?

"This experiment is open to all adults aged 18-65."

Answered by AI

What is the current enrollment figure for this research endeavor?

"Affirmative. According to clinicaltrials.gov, the trial was first published on March 27th 2023 and is now seeking 32 patients from a single location."

Answered by AI

Are new patient enrollees welcomed into this experiment at the moment?

"According to clinicaltrials.gov, the trial is actively seeking out participants; it was initially posted on March 27th 2023 and underwent a recent update on March 28th of the same year."

Answered by AI

To whom is enrollment to this trial open?

"The study is seeking 32 individuals aged 18-65 affected by side effects, who possess a BMI between 18.0 and 33.0 kg/m2 inclusive, along with at least 50.0kg of body weight to the highest maximum of 100.0kg as measured in screening tests."

Answered by AI
~0 spots leftby Apr 2024