None listed
Conditions
Brief summary
This is a Phase Ib study to investigate the safety, tolerability, efficacy and PK of ZL-1102 in subjects with mild-to-moderate chronic plaque psoriasis (CPP). The study consists of 2 Parts: Part A Part A is open-label. After a 30-day screening period, six (6) subjects with CPP will receive a single topical treatment with ZL-1102 to a suitable psoriatic plaque followed by a 1-week observation period for safety/tolerability. Part B Part B is a double-blind, two-arm comparison of ZL-1102 Gel vs. Vehicle (placebo only). Approximately 44 subjects with CPP will be randomized in a 1:1 ratio to receive study medication of ZL-1102 Gel or Vehicle.
Interventions
The study consists of 2 Parts: Part A & Part B
Part A is open-label where subjects with CPP will receive a single topical treatment with ZL-1102 to a suitable psoriatic plaque followed by a 1-week observation period for safety/tolerability.
Subjects who are eligible for the study will report to study sites on Day 1 for baseline evaluations.
There will be pre-dose PK sampling and intensive PK sampling for 24 hours post-dose. After completion of the safety evaluation in Part A, and in the absenc
The study consists of 2 Parts: Part A & Part B Part A is open-label where subjects with CPP will receive a single topical treatment with ZL-1102 to a suitable psoriatic plaque followed by a 1-week observation period for safety/tolerability. Subjects who are eligible for the study will report to study sites on Day 1 for baseline evaluations. There will be pre-dose PK sampling and intensive PK sampling for 24 hours post-dose. After completion of the safety evaluation in Part A, and in the absence of findings that would trigger stop criteria, enrollment of subjects for Part B will be started the dose of ZL-1102 administered: 2.3g/tube, recommended dosage to target plaque is approximately 0.15mg~0.3mg /cm2 [ZL-1102, 1% (w/w) Gel. Topical application should be based on the initial size of target plaque. Part B Part B is a double-blind, two-arm comparison of ZL-1102 Gel vs. Vehicle (placebo only). Approximately 44 subjects with CPP will be randomized in a 1:1 ratio to receive study medication of ZL-1102 Gel or Vehicle. Part B will consist of a screening period, (Day -30 till Day -1), a 4-week treatment period during which study drug will be applied topically to a suitable psoriatic plaque, and a 2- week follow-up period. study treatment: twice daily (BID) the dose of ZL-1102 administered: 2.3g/tube, recommended dosage to target plaque is approximately 0.15mg~0.3mg /cm2 [ZL-1102, 1% (w/w) Gel. Topical application should be based on the initial size of target plaque. The overall study duration is approximately 6 months (4.5 months recruitment plus 1.5 months study observation period). Route of Administration is Topical Dosage Formulation: gel clinician or research nurse administers the gel. adherence or fidelity will be assessed: in Part B, only the 1 tube each time study drug applied in clinic at D1, D8, D15 and D22. The weights should be recorded to the nearest 0.01gat minimum. And the subjects are trained to apply study drug as clinician or research nurse do, and record it in the patient diary. frequency of administration in Part B: Study drug (ZL-1102 or matching placebo) will be applied twice daily for 28 days. No participants in Part A can participate in Part B.
Sponsors
Zai Lab (Shanghai) Co., Ltd.
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Signed and dated Informed Consent Form 2. Male or female subjects aged 18 to 75 years 3. Stable chronic mild-to-moderate plaque-type psoriasis at screening and baseline: a. PASI less than or equal to 15 and b. affected body surface area (BSA) less than or equal to 10% of total body area 4. Suitable psoriatic plaque (ALL criteria apply): a. Lesion size: greater than 9 cm2 to 100 cm2 b. Lesion stable for greater than or equal to 3 months (by subject recall) c. Lesional/local PASI score greater than 6 in Part A and greater than 8 in Part B d. Plaque amenable to topical treatment, self-administration and not near the site(s) of venesection 5. Subject willing and able to avoid excess exposure to natural or artificial ultraviolet light 6. Negative pregnancy test (defined as negative serum pregnancy test at screening and negative urine pregnancy test prior to dosing on Day 1) for females of child-bearing potential (defined as pre-menopausal, less than 2 years post-menopausal, not surgically sterile). Details related to effective contraception are listed in the main protocol.
Exclusion criteria
Subjects who meet ANY of the following exclusion criteria are not eligible for participation: 1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis, palmar, plantar, scalp or nail disease) at screening 2. Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) 3. Ongoing use of topical or systemic treatments specified below and prior use of these therapeutics unless discontinued by interval as stated: • Biological agents: 12 weeks e.g., adalimumab, etanercept, infliximab, ustekinumab and others • Other systemic immunomodulating therapies: 4 weeks e.g., methotrexate, cyclosporine, fumaric acid (derivatives), systemic corticosteroids • Photochemotherapy: 4 weeks e.g., ultraviolet A with psoralen (PUVA) • Phototherapy e.g., ultraviolet A (UVA) or ultraviolet B (UVB): 2 weeks • Other investigational drugs: 4 weeks (or 5 half-lives, whichever is longer) • Topical therapies for CPP: 2 weeks e.g., corticosteroids (TCS), vitamin D analogues, retinoids 4. Active systemic infections (other than common cold) or local infection of the suitable plaque to be treated during the 2 weeks prior to randomization 5. Positive test for HIV (HIV Ab), HBV (HBsAg or HBcAb or HBV DNA) or HCV (HCV RNA) at screening 6. History of hypersensitivity to any human or humanized biological agents judged as significant by the investigator 7. Any severe, progressive or uncontrolled medical or psychiatric condition at baseline that in the judgment of the investigator prevents participating in the study 8. Any clinically significant abnormal laboratory tests at screening (e.g. AST or ALT greater than 2 times ULN) 9. Inability or unwillingness to undergo repeated venipuncture and additionally (in Part B only) for skin biopsy 10. History or evidence of drug or alcohol abuse within 1 year prior to screening, as determined by history. For Part A, a urine drug screen and alcohol breath test should be done at screening and Day -1 or done during screening within 48 hours of Day 1 For Part B, a urine drug screen should be done at screening. Urine Drug Test includes all of the following: Amphetamines (AMP), Methamphetamines (MET), Methadone (MTD), Barbiturates (BAR), Benzodiazepines (BZO), Cocaine (COC), Opiates (OPI), Methyl enedioxy methamphetamine (MDMA), Phencyclidine (PCP), Tetrahydrocannabinol (THC) 11. Pregnant or nursing (lactating) women 12. Dementia or other neurological disease impairing understanding and compliance with treatment procedure. Visual, physical and any other impairments that interferes with a subject’s ability to complete study procedures and compliance with study protocol. 13. Subjects with confirmed malignancies, except for adequately treated in situ cervical carcinoma, or non-metastatic basal call or squamous cell carcinomas of the skin not involving or near the target lesion. 14. Subjects have live vaccine within 6 weeks prior to dosing on Day 1. 15. Subjects with active tuberculosis (TB) or untreated latent TB per local guidelines. 16. Subjects who, in the opinion of the investigator, are unable or unlikely to comply with the administration schedule and study evaluations. 17. Subjects with prior exposure to ZL-1102.
Outcome results
None listed