A 4 Week Study of the Safety, Tolerability, and Pharmacodynamics of ShK-186 (Dalazatide) in Active Plaque Psoriasis

NCT ID: NCT02435342

Last Updated: 2015-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-03-31

Brief Summary

The primary purpose of this study is to examine safety outcomes in active plaque psoriasis patients after systemic administration of dalazatide. Clinical outcome measures will also be assessed.

Detailed Description

The primary purpose of this study is to examine safety outcomes in active plaque psoriasis patients after systemic administration of dalazatide. Clinical outcome measures will also be assessed.

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

30ug dalazatide

12 subjects, 10 given active agent and 2 given placebo by subcutaneous injection twice weekly for 4 weeks.

Group Type: EXPERIMENTAL

dalazatide

Intervention Type: DRUG

Subcutaneous injection twice per week for a total of 9 doses, followed by four weeks of follow-up.

placebo

Intervention Type: DRUG

placebo, Subcutaneous injection twice per week for a total of 9 doses

60ug dalazatide

12 subjects, 10 given active agent and 2 given placebo by subcutaneous injection twice weekly for 4 weeks.

Group Type: EXPERIMENTAL

dalazatide

Intervention Type: DRUG

Subcutaneous injection twice per week for a total of 9 doses, followed by four weeks of follow-up.

placebo

Intervention Type: DRUG

placebo, Subcutaneous injection twice per week for a total of 9 doses

Interventions

dalazatide

Subcutaneous injection twice per week for a total of 9 doses, followed by four weeks of follow-up.

Intervention Type: DRUG

placebo

placebo, Subcutaneous injection twice per week for a total of 9 doses

Intervention Type: DRUG

Other Intervention Names

ShK-186

Eligibility Criteria

Inclusion Criteria

1. Adult male and female subjects, ages 18-65;

2. Active plaque psoriasis with ≥3% BSA involved;

3. An adequate number of vulgar psoriatic plaques of at least 2 cm X 2 cm with Target Lesion Investigator Global Assessment scores >3, that are not located on the face, scalp, groin, genitals, folds, palms or soles

4. Weight of 50 - 100 kg;

5. Non-child bearing potential or willingness to use adequate contraception in order to prevent pregnancy from the screening visit until 60 days after the follow-up visit.

6. Subject will be evaluated for latent TB infection.

7. Able to communicate and able to provide valid, written informed consent;

Exclusion Criteria

The following will exclude potential subjects from the study:

1. Erythrodermic, predominantly guttate, exclusively palmar/plantar, or generalized pustular psoriasis;

2. Current drug-induced or aggravated psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta-blockers, calcium-channel blockers, or lithium carbonate);

3. Use of the following concurrent systemic medications: corticosteroids, retinoids, cyclosporine, methotrexate, or biologic agents.

4. Use of concurrent topical medications (must be discontinued at least 2 weeks prior to baseline);

5. UVA or UVB therapy within 4 weeks of baseline;

6. The presence of uncontrolled hypertension, uncontrolled diabetes, clinically significant cardiovascular disease, asthma or reduced pulmonary capacity, or a history of seizure or other neurologic disorder;

7. Presence or history of pre-existing paresthesia or neuropathy;

8. Abnormalities on neurological exam at screening or baseline;

9. Clinically significant ECG abnormalities, in the opinion of the Investigator;

10. History of any cancer requiring systemic chemotherapy or radiation;

11. The presence of acute infection or history of acute infection as judged by the Investigator within 7 days of baseline;

12. The presence of clinically significant laboratory abnormalities;

13. A positive hepatitis screen (Hepatitis BsAg or anti-HCV) or positive Human Immunodeficiency Virus (HIV) antibody test ;

14. History of treated or untreated TB

15. Any history of anaphylaxis that is important in the view of the Investigator;

16. Participation in another clinical trial with receipt of an investigational product within 90 days of baseline (or 5 half-lives of the previous drug, whichever is longer);

17. History of alcohol abuse that is important in the view of the Investigator;

18. Positive drug screen for amphetamines, barbituates, benzodiazepines, cocaine, cannabis, methamphetamine, methylenedioxymethanphetamine, opiates or phencyclidine

19. Inadequate venous access that would interfere with obtaining blood samples;

20. Positive pregnancy test at screening or at baseline or current lactation (female subjects only);

21. Inability or unwillingness to comply with study restrictions, return for follow up appointments, or other considerations, in the opinion of the Investigator, which would make the candidate unsuitable for study participation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kineta Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shawn Iadonato, PhD

Role: STUDY_DIRECTOR

Kineta Inc.

Locations

Innovaderm Research, Inc

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

186-03

Identifier Type: -

Identifier Source: org_study_id