Status Approved
First Submitted Date
2020/11/20
Registered Date
2020/12/14
Last Updated Date
2021/12/01
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005673 |
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Unique Protocol ID | CNUH 2020-07-013 |
Public/Brief Title | A Phase 1 study to evaluate the Safety, Tolerability and Pharmacokinetics of CT P59 in Healthy Subjects |
Scientific 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 |
Acronym | |
MFDS Regulated Study | Yes |
IND/IDE Protocol | |
Registered at Other Registry | Yes |
Name of Registry / Registration Number | ClinicalTrials.gov-NCT04525079 |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
---|---|
Board Approval Number | CNUH 2020-07-013 |
Approval Date | 2020-07-17 |
Institutional Review Board Name | Chungnam National University Hospital IRB |
Institutional Review Board Address | Clinical Trial Center (2F, Biomedical Convergence Research Center), Chungnam National University Hospital 266 Munhwa-ro, Jung-gu, Daejeon |
Institutional Review Board Telephone | 042-280-6781 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
---|---|
Name | JangHee Hong |
Title | MD, PhD |
Telephone | +82-42-280-6940 |
Affiliation | Chungnam National University Hospital |
Address | 266 Moonhwa-ro, Jung-Gu, Daejeon |
Contact Person for Public Queries | |
Name | JangHee Hong |
Title | MD, PhD |
Telephone | +82-42-280-6940 |
Affiliation | Chungnam National University Hospital |
Address | 266 Moonhwa-ro, Jung-Gu, Daejeon |
Contact Person for Updating Information | |
Name | JooHee Lee |
Title | Manager |
Telephone | +82-32-850-5809 |
Affiliation | Celltrion |
Address | 23, Academy-ro, Yeonsu-gu, Incheon, Korea |
4. Status
Study Site | Single | |
---|---|---|
Overall Recruitment Status | Completed | |
Date of First Enrollment | 2020-07-21 Actual | |
Target Number of Participant | 32 | |
Primary Completion Date | 2020-08-21 , Actual | |
Study Completion Date | 2020-11-05 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Chungnam National University | |
Recruitment Status | Completed | |
Date of First Enrollment | 2020-07-21 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
---|---|
Organization Name | Celltrion |
Organization Type | Pharmaceutical Company |
Project ID | CT-P59 1.1 |
2. Source of Monetary/Material Support | |
Organization Name | Ministry of Health & Welfare |
Organization Type | Government |
Project ID | CT-P59 1.1 |
6. Sponsor Organization
1. Sponsor Organization | |
---|---|
Organization Name | Celltrion |
Organization Type | Pharmaceutical Company |
7. Study Summary
Lay Summary | A Phase 1 study to evaluate the Safety, Tolerability and Pharmacokinetics of CT P59 in Healthy Subjects |
---|
8. Study Design
Study Type | Interventional Study |
---|---|
Study Purpose | Treatment |
Phase | Not applicable |
Intervention Model | Parallel |
Blinding/Masking | Double |
Blinded Subject | Subject, Investigator |
Allocation | RCT |
Intervention Type | Drug |
Intervention Description | TBD |
Number of Arms | 2 |
Arm 1 |
Arm Label CT-P59 Group |
Target Number of Participant 24 |
|
Arm Type Experimental |
|
Arm Description CT-P59 will be administrated. Subjects are randomized into 3:1 ratio. |
|
Arm 2 |
Arm Label Placebo Group |
Target Number of Participant 8 |
|
Arm Type Placebo comparator |
|
Arm Description Placebo will be administrated. Subjects are randomized into 3:1 ratio. |
9. Subject Eligibility
Condition(s)/Problem(s) |
Not Applicable-Etc
to Evaluate the Safety, Tolerability and Pharmacokinetics of CT P59 in Healthy Subjects |
---|---|
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 19Year~55Year |
|
Description • Subject is confirmed as negative in SARS-CoV-2 infection test on screening and Day -1 visits • Subject with a body weight of ≥ 50 kg and a body mass index between 18.0 and 29.9 kg/m2 (both inclusive). • 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 |
• 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 • 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 • History of or any concomitant active malignancy • History of or current infection with human immunodeficiency, syphilis, hepatitis B or hepatitis C • 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 • 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 • 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 |
Healthy Volunteers | Yes |
10. Outcome Measure(s)
Type of Primary Outcome | Safety | |
---|---|---|
Primary Outcome(s) 1 | ||
Outcome | To evaluate the preliminary safety and tolerability of CT-P59 |
|
Timepoint | up to Day 14 of the last enrolled subject |
|
Secondary Outcome(s) 1 | ||
Outcome | To evaluate the PK |
|
Timepoint | Whole study period (upto day 90) |
|
Secondary Outcome(s) 2 | ||
Outcome | To evaluate additional safety including immunogenicity |
|
Timepoint | Whole study period (upto day 90) |
11. Study Results and Publication
Result Registered |
Yes
Results Upload |
---|---|
Final Enrollment Number | 32 |
Number of Publication | 0 |
Results Upload | 결과 파일.pdf |
Date of Posting Results | 2021/11/30 |
Protocol URL or File Upload | protocol synopsis.pdf |
Brief Summary | This study was the first-in human study of CT-P59. It was 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. Single IV infusion over 90 minutes (±15 minutes) of CT-P59 in doses of 10 mg/kg, 20 mg/kg, 40 mg/kg and 80 mg/kg was safe and well-tolerated in healthy subjects and no new major safety concerns were identified. Based on the pharmacokinetic analysis, CT-P59 was approximately dose proportional in terms of maximal and systemic exposure over the studied dose range of 10 mg/kg to 80 mg/kg and these active moieties will be largely out of the systemic circulation after 5 half-lives, i.e. approximately 95 days after administration. |
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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