A Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and EU-Dupixent® in Healthy Adult Participants.

Korábbi kezelés

• Any clinically important medical/surgical procedure or trauma within 8 weeks of the screening visit, or any planned inpatient hospitalisation during the study period.
• Participant with prior exposure to dupilumab (Dupixent or biosimilar dupilumab).
• Participation in any interventional clinical trial or receipt of any investigational product within 30 days (or < 5 half-lives of investigational drug taken) prior to dosing.
• Participant with positive screen results for drugs of abuse or alcohol at screening or on admission to the Clinical Unit.
• Participant has received live vaccine(s) or live attenuated vaccines within 1 month prior to screening or plans to receive such vaccines during the study.
• Participant with known helminthic infection, or within 6 months prior to screening.
• Participant is unwilling to avoid consumption of coffee and caffeine-containing beverages within 48 hours prior to admission on Day -1 and not consuming caffeine before any outpatient visits.
• Participant with excess use of caffeine, which is defined as exceeding 500 mg caffeine/day (e.g., > 5 cups of coffee) within 14 days prior to administration of the study intervention.
• Participant has donated blood (> 500 mL) or blood products within 56 days prior to admission.
• Participant has used over-the-counter medications (including vitamins), prescription medications or herbal remedies from 14 days prior to admission until the End of Study visit.
• Participant has previously been enrolled in this clinical study.

Más betegség

• Participant with history of any clinically important disease or disorder which, may either put the participant at risk during study.
• Participant with current malignancy or within the past 5 years and suspected malignancy or undefined neoplasms.
• Participant with history or presence of chronic gastrointestinal, hepatic, renal, or pancreatic disease or ongoing acute disease in these organs, or any other condition constituting a risk when taking the study intervention.
• Participant with diagnosis or history of immunodeficiency or increased susceptibility to severe infections, or a clinically significant infection within 4 weeks of screening.
• Known or suspected history of alcohol or illicit drug abuse or excessive intake of alcohol within 1 year of screening, as judged by the Investigator.
• Participant has a positive test for human immunodeficiency virus antibody or positive results for Hepatitis B surface antigen, anti-hepatitis B core antibody or Hepatitis C virus antibody, except for vaccinated participants or participants with past but resolved hepatitis, at screening.
• History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to monoclonal or polyclonal antibodies. History of allergy or reaction to any formulation components of the study intervention.

Laborértékek

• Participant with white blood cell count < lower limit of normal at screening or admission.

Egyéb

• Any clinically important abnormalities in clinical chemistry, haematology, or urinalysis results at screening or admission, as judged by the Investigator.
• Participant with any clinically significant abnormal finding in vital signs as judged by the Investigator.
• Any clinically significant abnormalities on 12-lead ECG at screening or admission (Day -1) to the Clinical Unit, as judged by the Investigator.
• Participants who smoke more than 5 cigarettes per day or consume equivalent nicotine substitutes, including e-cigarettes or inability to refrain from smoking during the in-house stay period.
• Participant is unable to understand the protocol requirements, instructions and study related restrictions, the nature, scope, and possible consequences of the clinical study.
• Participant is unlikely to comply with the protocol requirements, instructions and study related restrictions.
• Vulnerable participants, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
• Involvement of any Chong Kun Dang Pharmaceutical, Parexel or study site employee or their close relatives.

• Participant is capable of giving signed informed consent
• Male and female healthy participant between 18 to 55 years of age (inclusive) at screening, with suitable veins for cannulation or repeated venipuncture.
• Body-mass index between 18.5 - 29.9 kg/m2 (inclusive) with body weight ≥ 50 kg and < 95 kg at screening.
• Participant agrees to be available for the entire duration of the study
• All female participants must have a negative serum pregnancy test at the screening visit and on admission to the Clinical Unit (Day -1).
• Female Participants:
  • A female participant is eligible to participate if she is not pregnant, not be lactating and not breastfeeding, and at least one of the following conditions applies
• Male Participants • Male participants and their female spouse/partners who are of childbearing potential must be using 2 forms of birth control from screening until at least 3 months after the end of study intervention dose.