A Study of HB0017 in Patients With Moderate to Severe Plaque Psoriasis

NCT05442788 | Completed Phase 1

• 1 other identifier: HB0017-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, placebo-controlled, dose-escalation Phase Ib study to evaluate the safety, tolerability, and pharmacokinetics of HB0017 following multiple dose in patients with moderate to severe plaque psoriasis.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (8)

• Incidence of treatment emergent AE/SAEs

  From baseline through week 20

• Elimination half-life (T1/2)

  From baseline through week 20

• Area under drug-time curve (AUC)

  From baseline through week 20

• Total clearance (CL/F)

  From baseline through week 20

• Maximum serum concentrations (Cmax)

  From baseline through week 20

• Mean retention time (MRT)

  From baseline through week 20

• Volume of distribution (Vz/F)

  From baseline through week 20

• Peak time(Tmax)

  From baseline through week 20

Secondary Outcomes (5)

• PASI 75

  Week 12

• PASI 90

  Week 12

• PASI 100

  Week 12

• sPGA

  Week 12

• Immunogenicity

  From baseline through week 20

Study Arms (3)

HB0017 150mg

EXPERIMENTAL

10 subjects is randomly assigned to receive HB0017 150mg or matching placebo at a ratio of 4:1.

Biological: HB0017 150mg or matching placebo

HB0017 300mg

EXPERIMENTAL

10 subjects is randomly assigned to receive HB0017 300mg or matching placebo at a ratio of 4:1.

Biological: HB0017 300mg or matching placebo

HB0017 450mg

EXPERIMENTAL

10 subjects is randomly assigned to receive HB0017 450mg or matching placebo at a ratio of 4:1.

Biological: HB0017 450mg or matching placebo

Interventions

HB0017 150mg or matching placebo BIOLOGICAL

Each subject receive injection at week0(Day1), week 3(Day22), week 6(Day43) and week 9(Day64), respectively.

HB0017 150mg

HB0017 300mg or matching placebo BIOLOGICAL

Each subject receive injection at week0(Day1), week 3(Day22), week 6(Day43) and week 9(Day64), respectively.

HB0017 300mg

HB0017 450mg or matching placebo BIOLOGICAL

Each subject receive injection at week0(Day1), week 3(Day22), week 6(Day43) and week 9(Day64), respectively.

HB0017 450mg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must meet the following criteria to be eligible for study entry:
• Male or female subjects age≥18 and ≤60 years.
• Weight≥50kg,Body Mass Index(BMI)≥18 and ≤28kg/m2.
• Subjects with stable moderate to severe chronic plaque psoriasis of ≥6 months' duration with or without psoriatic arthritis.
• Baseline subjects with moderate or severe plaque psoriasis, defined as below: body surface area (BSA) involvement ≥10%,Psoriasis Area and Severity Index (PASI) ≥12, Static Physician Global Assessment (sPGA) ≥3.
• Candidates for systemic therapy or phototherapy judged by the investigator or accepted systemic therapy or phototherapy at least one time before.
• Women who are at childbearing age(not pregnant or breast-feeding), and subjects and their partners voluntarily use contraceptive methods deemed effective by the investigator during treatment and for at least 6 months after the last study medication.
• During the study, Prolonged exposure to sunlight and the use of ultraviolet health rooms or other ultraviolet light sources must be avoided.
• Informed consent must be obtained in writing for all subjects enrolled into the study.
• Subjects must be willing and able to complete study procedures and follow-up examinations.

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from study entry:
• Screening for psoriasis other than chronic plaque (such as pustular erythroderma and guttate psoriasis).
• Drug-induced psoriasis (including, but not limited to, new psoriasis or exacerbations of psoriasis caused by beta blockers calcium channel inhibitors or lithium).
• Have other active skin diseases or skin infections (bacterial, fungal or viral) that may interfere with clinical evaluation of psoriasis.
• Patients with symptoms or signs of progressive or uncontrolled kidney, liver, blood, gastrointestinal, endocrine, lung, heart, nerve, mental or brain diseases, or other chronic diseases that are not suitable for the study.
• Screening of patients with radiographic abnormalities within the preceding 3 months suggesting pulmonary infection or fibrosis or tumor.
• History of exposure to active tuberculosis (TB); History of TB infection; TB lesions on chest X-ray/chest CT. QuantiFERON®-TB Gold orT-SPOT®.TB positive in the 6 weeks prior to first administration.
• Having any severe systemic or local infection within 2 months prior to screening.
• History of chronic recurrent infectious diseases, including but not limited to chronic kidney infections chronic chest infections (such as bronchiectasis) complex urinary tract infections (recurrent pyelonephritis or chronic cystitis) or open,drainage or skin wound infections or ulcers.
• History of underlying or active granulomatous infection, including histoplasmosis or coccosis.
• Non-tuberculous mycobacterial infection or opportunistic infection (e.g.,cytomegalovirus infection with pneumocystis carinii and aspergillosis) within 6 months prior to screening.
• Subjects whose blood pressure is higher than 140 mmHg/90 mmHg (if their blood pressure exceeds this threshold, they may be retested after at least 10 minutes of quiet rest at the discretion of the investigator; if their blood pressure is lower than this threshold, they may be enrolled; Patients who have a history of hypertension but have stable blood pressure control and meet the requirements of the program can be included in the group).
• Having unstable cardiovascular disease was defined as having had a clinical deterioration in the last 3 months (e.g., unstable angina or rapid atrial fibrillation) or having been hospitalized for heart disease in the last 3 months.
• Significant abnormalities in heart rate, ECG and respiratory system, and has been judged to be of clinical significance by the investigator.
• Liver, kidney and blood abnormalities, including:

Sponsors & Collaborators

• Huabo Biopharm Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233070, China

Location

Related Publications (1)

• Jiang C, Du Y, Liu X, Wang J, Ge C, Xu J, Wang S, Li B, Zhu G, Zhang W, Qian Q, Ma C, Zhu X, Zhan Y, Yang Y. Safety, tolerability, pharmacokinetics and efficacy of HB0017, a humanized monoclonal antibody that targets interleukin-17A, in healthy participants and patients with moderate-to-severe plaque psoriasis. Br J Dermatol. 2023 Dec 20;190(1):28-36. doi: 10.1093/bjd/ljad315.

  PMID: 37669307 DERIVED

Study Officials

• Congjun Jiang, Master

  The First Affiliated Hospital of Bengbu Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 5, 2022
• Study Start: September 2, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: July 7, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)