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Antifungal Agent

Placebo for Side Effects

Phase 1
Waitlist Available
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
Female subjects must have a negative pregnancy test
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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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.

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ciclopirox Olamine Oral
2023
Completed Phase 1
~50

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Atlas Molecular PharmaLead Sponsor
~20 spots leftby May 2025
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