Clinical trial NCT04525079: To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P59 in Healthy Subjects
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P59 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: SARS-CoV-2 Infection
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2020-08-25
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SCREENING

Brief summary: This is a Phase I study that randomized, double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to evaluate Safety, Tolerability and Pharmacokinetics of CT-P59 in Healthy Subjects.

Detailed description: CT-P59 is a monoclonal antibody targeted against SARS-CoV-2 spike RBD as a treatment for SARS CoV 2 infection. CT-P59 is currently being developed by the Sponsor as a potential treatment for SARS-CoV-2 infection. In this study, safety, tolerability, and pharmacokinetics of CT-P59 will be evaluated in healthy subjects.

Eligibility criteria: Inclusion Criteria:

Each subject must meet all of the following criteria to be randomized in this study:

1. Subject is a healthy male or female subject, aged between 19 to 55 years (both inclusive). Health is defined as no clinically relevant abnormalities identified by Investigator's decision based on a detailed medical history, full physical examination, including blood pressure, heart rate, respiratory rate, and body temperature measurements, 12-lead electrocardiogram (ECG) and clinical laboratory tests prior to the study drug administration.
2. Subject is confirmed as negative in SARS-CoV-2 infection test on screening and Day -1 visits.
3. Subject with a body weight of ≥ 50 kg and a body mass index between 18.0 and 29.9 kg/m2 (both inclusive).
4. Subject is able to understand and to comply with protocol requirements, instructions, and restrictions.
5. Subject voluntarily agrees to participate in this study and has given a written informed consent prior to undergoing any of the screening procedures.

Exclusion Criteria:

Subject meeting any of the following criteria will be excluded from the study:

1. Subject has a medical history or current presence of disease including one or more of the following(s):

   1. History of or current allergic reaction such as asthma, urticaria, angioedema, and eczematous dermatitis considered as clinically significant in the Investigator's opinion or hypersensitivity including known or suspected clinically relevant drug hypersensitivity to any monoclonal antibody or any component of study drug
   2. History of or current medical condition including gastrointestinal, renal, endocrine, neurologic, autoimmune, hepatic, hematological metabolic (including known diabetes mellitus), cardiovascular, or psychiatric condition classed as clinically significant by the Investigator
   3. History of or any concomitant active malignancy
   4. History of or current infection with human immunodeficiency, syphilis, hepatitis B or hepatitis C
   5. History of or current infection requiring a course of systemic anti-infective that was completed within 28 days prior to the study drug administration or a serious infection (associated with hospitalization or which required IV antibiotics) within 6 months before the study drug administration
   6. History of an illness within 28 days prior to the study drug administration that is identified as clinically significant by the Investigator or requires hospitalization
   7. History of surgical intervention or an operation within 28 days prior to the study drug administration or plans to have a surgical procedure during the study period
2. Subject had a history of or concurrent use of medications including any prior therapy of following(s):

   1. Prescription medication (excluding hormonal birth control), over-the-counter drug, dietary supplements or herbal remedies within 7 days or 5 half-lives (whichever is longer) prior to the study drug administration
   2. Any vaccination within 4 weeks prior to the study drug administration
   3. Treatment with any monoclonal antibody, fusion protein, or blood transfusion within 6 months or 5 half lives (which is longer) prior to the study drug administration or current use of biologics
   4. Treatment with any other investigational drug within 6 months or 5 half lives (which is longer) prior to the study drug administration

Primary outcomes:
measure: Preliminary Safety and Tolerability of CT-P59
timeFrame: Up to Day 14 after the subject administered with the study drug (Day 1)
Secondary outcomes:
measure: Additional Safety of CT-P59 Including Immunogenicity
timeFrame: Up to 90 Days
measure: Pharmacokinetic (PK) Parameters: AUC0-inf and AUC0-last
timeFrame: Up to 90 Days
measure: Pharmacokinetic (PK) Parameters: AUC0-inf/Dose and AUC0-last/Dose
timeFrame: Up to Day 90
measure: Pharmacokinetic (PK) Parameter: Cmax
timeFrame: Up to Day 90
measure: Pharmacokinetic (PK) Parameter: Cmax/Dose
timeFrame: Up to Day 90
measure: Pharmacokinetic (PK) Parameter: Tmax
timeFrame: Up to 90 Days
measure: Pharmacokinetic (PK) Parameter: t1/2
timeFrame: Up to Day 90
measure: Pharmacokinetic (PK) Parameter: %AUCext
timeFrame: Up to Day 90
measure: Pharmacokinetic (PK) Parameter: λz
timeFrame: Up to Day 90
measure: Pharmacokinetic (PK) Parameter: CL
timeFrame: Up to Day 90
measure: Pharmacokinetic (PK) Parameter: Vz
timeFrame: Up to Day 90
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
Study officials:
References:
citation: Kim JY, Jang YR, Hong JH, Jung JG, Park JH, Streinu-Cercel A, Streinu-Cercel A, Sandulescu O, Lee SJ, Kim SH, Jung NH, Lee SG, Park JE, Kim MK, Jeon DB, Lee YJ, Kim BS, Lee YM, Kim YS. Safety, Virologic Efficacy, and Pharmacokinetics of CT-P59, a Neutralizing Monoclonal Antibody Against SARS-CoV-2 Spike Receptor-Binding Protein: Two Randomized, Placebo-Controlled, Phase I Studies in Healthy Individuals and Patients With Mild SARS-CoV-2 Infection. Clin Ther. 2021 Oct;43(10):1706-1727. doi: 10.1016/j.clinthera.2021.08.009. Epub 2021 Aug 23.
citation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.