A Phase I Study of ICP-022 in Healthy Subjects

NCT03189017 | Completed Phase 1 DMC

• 1 other identifier: ICP-CL-001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, randomized, double-blind, placebo-controlled, dose escalation study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ICP-022 following oral single and multiple escalating dose administration.

Conditions

Systemic Lupus Erythematosus; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events

  Number of participants with treatment-related adverse events will be collected and the percentage of AE of different grades will be assessed.

  up to 28 days

Secondary Outcomes (6)

• Maximum plasma drug concentrations (Cmax)

  up to 16 days

• Time of maximum plasma drug concentrations (Tmax)

  up to 16 days

• Area under the concentration time curve up to the time "t" (AUC(0-t))

  up to 16 days

• Area under the concentration time curve up to the last data point above LOQ (AUC(last))

  up to 16 days

• Apparent half-life for designated elimination phases (t½)

  up to 16 days

Study Arms (2)

ICP-022

EXPERIMENTAL

There are 5 cohorts in the Part 1 phase of the trial. Three quarters of subjects will be randomized to receive ICP-022 in a double-blind fashion. Five dose levels will be evaluated; dose escalation steps may be modified based on the safety from the previous dose. Cohort 4 will return on Day 8 and receive a single dose of ICP-022 under fed conditions. In Part 2 phase of the trial,three quarters of subjects will be randomized to receive the ICP-022 in a double-blind fashion in 3 cohorts. ICP-022 will be administered once a day for 14 consecutive days.

Drug: ICP-022

Placebos

PLACEBO COMPARATOR

In part 1 phase of the trial, one quarter of subjects will be randomized to receive placebo in a double-blind fashion. Cohort 4 will return on Day 8 and receive a single dose of placebo under fed conditions. In Part 2 phase of the trial,one quarter of subjects will be randomized to receive placebo in a double-blind fashion. Placebo will be administered once a day for 14 consecutive days.

Drug: Placebos

Interventions

ICP-022 DRUG

The drug product is a white, round, uncoated tablet.

ICP-022

Placebos DRUG

The placebo is a white, round, uncoated tablet.

Placebos

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects age ≥18 and ≤55 years
• Body mass index ≥19 and ≤31 kg/m2, with minimum body weight of 50kg
• No clinically significant findings in the medical history and physical examination, especially with regard to the respiratory, heart, immune system, pancreas, liver, bile and gastrointestinal systems
• No clinically significant laboratory values and urinalysis, unless the investigator considers any abnormality to be clinically irrelevant;
• Subjects with a partner of child-bearing potential must be willing to use an approved form of contraception with a failure rate of \<1%. Subjects must be willing to use a condom during sexual intercourse whether or not their partner is of child-bearing potential from screening until 90 days after their final study visit.
• Normal electrocardiogram (ECG), blood pressure, and heart rate, unless the investigator considers any abnormality to be clinically irrelevant
• Informed consent must be obtained in writing for all subjects personally at enrollment

You may not qualify if:

• Subjects with medically important events
• Having 1st degree relative with coronary heart disease at age \<60
• Using of prescription drugs including but not limited to those known to interfere with metabolism of drugs within 30 days prior to dosing
• Exposure to any other medication, including over-the-counter medications, herbal remedies and vitamins for at least 14 days before randomization (except paracetamol
• Participation in another study with any investigational drug in 30 days or five half-lives (whichever is longer) preceding the study
• Current smoker, defined as more than 10 cigarettes or equivalent per day before the beginning of the study (participants currently smoking ≤10 cigarettes daily and able to completely stop smoking during the study from screening until follow-up are eligible)
• Symptoms of a clinically significant illness in the 3 months before the study
• Presence or sequelae of respiratory, gastrointestinal, immune system, heart, liver or kidney disease, including asymptomatic unconjugated hyperbilirubinemia or asthma, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs
• Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease
• Hemorrhoids or anal diseases with regular or recent presence of blood in feces
• History of immediate hypersensitivity to any medications or any food allergy, and acute phase of allergic rhinitis in the previous 2 weeks before randomization
• Blood or plasma donation of more than 500 mL during the previous 2 months before randomization and/or more than 50 mL in the 2 weeks prior to screening, or plan to donate any additional blood for 12 weeks after completing the study
• Subjects with a positive quantiFERON® test at screening or within 6 months prior to Day 1
• Positive test for human immunodeficiency virus (HIV)
• Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), unless caused by immunization

Sponsors & Collaborators

• Innocare Pharma Australia Pty Ltd: lead

Study Sites (1)

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

Location

Related Publications (6)

• Choi J, Kim ST, Craft J. The pathogenesis of systemic lupus erythematosus-an update. Curr Opin Immunol. 2012 Dec;24(6):651-7. doi: 10.1016/j.coi.2012.10.004. Epub 2012 Nov 3.

  PMID: 23131610 BACKGROUND

• Holroyd CR, Edwards CJ. The effects of hormone replacement therapy on autoimmune disease: rheumatoid arthritis and systemic lupus erythematosus. Climacteric. 2009 Oct;12(5):378-86. doi: 10.1080/13697130903025449.

  PMID: 19591008 BACKGROUND

• Sanz I, Lee FE. B cells as therapeutic targets in SLE. Nat Rev Rheumatol. 2010 Jun;6(6):326-37. doi: 10.1038/nrrheum.2010.68.

  PMID: 20520647 BACKGROUND

• Garcia A, De Sanctis JB. A Review of Clinical Trials of Belimumab in the Management of Systemic Lupus Erythematosus. Curr Pharm Des. 2016;22(41):6306-6312. doi: 10.2174/1381612822666160831103254.

  PMID: 27587201 BACKGROUND

• Rovin BH, Furie R, Latinis K, Looney RJ, Fervenza FC, Sanchez-Guerrero J, Maciuca R, Zhang D, Garg JP, Brunetta P, Appel G; LUNAR Investigator Group. Efficacy and safety of rituximab in patients with active proliferative lupus nephritis: the Lupus Nephritis Assessment with Rituximab study. Arthritis Rheum. 2012 Apr;64(4):1215-26. doi: 10.1002/art.34359. Epub 2012 Jan 9.

  PMID: 22231479 BACKGROUND

• Harandi A, Zaidi AS, Stocker AM, Laber DA. Clinical Efficacy and Toxicity of Anti-EGFR Therapy in Common Cancers. J Oncol. 2009;2009:567486. doi: 10.1155/2009/567486. Epub 2009 May 6.

  PMID: 19424511 BACKGROUND

Related Links

• The Association of the British Pharmaceutical Industry (ABPI) represents innovative research-based biopharmaceutical companies, large, medium and small, leading an exciting new era of biosciences in the UK.
• AMH Online is the Australian Medicines Handbook for desktops, laptops, tablets and smartphones with internet access.

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Sepehr Shakib

  CMAX

  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 12, 2017
• First Posted: June 16, 2017
• Study Start: July 3, 2017
• Primary Completion: February 5, 2018
• Study Completion: October 30, 2018
• Last Updated: August 1, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)