First-in-Human Study of CLS003 ICVT in Subjects With Cutaneous Warts
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- Body mass index (BMI) between 18 and 30kg/m2, inclusive
- Fitzpatrick skin type I-II-III-IV
- Healthy subjects (male, non-pregnant female), 18 to 65 years of age, inclusive.
- ...
- Body mass index (BMI) between 18 and 30kg/m2, inclusive
- Fitzpatrick skin type I-II-III-IV
- Healthy subjects (male, non-pregnant female), 18 to 65 years of age, inclusive.
- At least 4 cutaneous warts on the hands, separated by at least 1cm of skin
Exclusion Criteria
- A positive test for drugs of abuse at screening
- Have used salicylic acid or any other over-the-counter- wart-removing product in the treatment area within 30 days prior to enrollment
- Have required systemic intake of immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) with 30 days prior to enrollment or during the course of the study.
- ...
- A positive test for drugs of abuse at screening
- Have used salicylic acid or any other over-the-counter- wart-removing product in the treatment area within 30 days prior to enrollment
- Have required systemic intake of immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) with 30 days prior to enrollment or during the course of the study.
- For women, a positive pregnancy test and/or nursing at screening
- History of alcohol or illicit drug abuse
- Positive test results for Hepatitis B, Hepatitis C or HIV
- Have received cryotherapy in the treatment area within 60 days prior to enrollment
Summary
- Conditions
- Cutaneous Warts
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Inclusion Criteria
- Body mass index (BMI) between 18 and 30kg/m2, inclusive
- Fitzpatrick skin type I-II-III-IV
- Healthy subjects (male, non-pregnant female), 18 to 65 years of age, inclusive.
- ...
- Body mass index (BMI) between 18 and 30kg/m2, inclusive
- Fitzpatrick skin type I-II-III-IV
- Healthy subjects (male, non-pregnant female), 18 to 65 years of age, inclusive.
- At least 4 cutaneous warts on the hands, separated by at least 1cm of skin
Exclusion Criteria
- A positive test for drugs of abuse at screening
- Have used salicylic acid or any other over-the-counter- wart-removing product in the treatment area within 30 days prior to enrollment
- Have required systemic intake of immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) with 30 days prior to enrollment or during the course of the study.
- ...
- A positive test for drugs of abuse at screening
- Have used salicylic acid or any other over-the-counter- wart-removing product in the treatment area within 30 days prior to enrollment
- Have required systemic intake of immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) with 30 days prior to enrollment or during the course of the study.
- For women, a positive pregnancy test and/or nursing at screening
- History of alcohol or illicit drug abuse
- Positive test results for Hepatitis B, Hepatitis C or HIV
- Have received cryotherapy in the treatment area within 60 days prior to enrollment
Tracking Information
- NCT #
- NCT02106260
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: J. (Koos) Burggraaf, MD, PhD Centre for Human Drug Research
- J. (Koos) Burggraaf, MD, PhD Centre for Human Drug Research