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A Study to Investigate the Safety, Tolerability, Pharmacokinetic, and Efficacy of ABY-035/AFO2

Study Purpose

The purpose of this first-in-human study of the formulation ABY-035/AFO2 is to investigate the safety, tolerability and efficacy after multiple doses in sequential escalating dose cohorts in psoriasis subjects.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Diagnosed with plaque psoriasis at least 6 months prior to Screening, if suitable for systemic treatment or phototherapy, and if have a stable active plaque-type psoriasis (stable is defined as without clinically significant flares during the 12 weeks before the first dose).
Subjects with psoriatic arthritis may be included if they have not received systemic treatment within the last 12 months and their disease is stable.
  • - Subjects must use adequate contraceptive measures from the Screening Visit until 4 weeks after final administration of the investigational product.
  • - Subject that has a maximum body weight of 243 pounds (110 kg)

    Exclusion Criteria:

    - Subjects with psoriatic arthritis that have received systemic treatment within the last 12 months.
  • - Subjects will not be eligible if they have current forms of psoriasis other than chronic plaque-type (e.g. erythrodermic, guttate, or pustular) - Subject that has a current drug-induced psoriasis form (e.g. a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) - Subject that has a history of recurrent or medically important infections, a clinically significant candida infection or clinically significant skin infection with Staphylococcus aureus requiring systemic treatment in the last 12 months prior to the first administration of study drug.
  • - Subject that smokes more than 15 cigarettes, or equivalent in tobacco, per day Subject with a history of suicide attempt or suicidal behavior.
  • - Any live vaccination within 3 months prior to Screening.
- Subject that is pregnant, intends to become pregnant during the course of the study, or is lactating

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03580278
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Affibody
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Tooraj Raoof, MD
Principal Investigator Affiliation Encino Research Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriasis
Arms & Interventions

Arms

Experimental: Cohort 1:75 mg ABY-035/AFO2

Cohort 1: 75 mg ABY-035/AFO2, once daily for 14 days

Experimental: Cohort 2: 150 mg ABY-035/AFO2

Cohort 2: 150 mg ABY-035/AFO2 once daily for up to 28 days

Interventions

Biological: - ABY-035/AFO2

Analyze the safety, tolerability, PK, and efficacy of ABY-035/AFO2 that 25 subjects will receive for treatment of their active plaque psoriasis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Raoof, Joseph, Encino, California

Status

Recruiting

Address

Raoof, Joseph

Encino, California, 16133

Site Contact

Joseph Raoof

joseph@drraoof.com

818-788-5060

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