Clinical Study of Recombinant Humanized CTLA-4-FC Fusion Protein Injection in Healthy Subjects
a Single-Center, Randomized, Double-Blind, Does-Escalation Phase I Clinical Study to Evaluate the Tolerability, Safety, PK Characteristics of Recombinant Humanized CTLA-4-FC Fusion Protein Injection in Healthy Subjects.
1 other identifier
interventional
46
1 country
1
Brief Summary
This is a single-center, randomized, double-blind, does-escalation Phase I Clinical Study that aim to evaluate the tolerability, safety and PK Characteristics of recombinant humanized CTLA-4-FC fusion protein injection in Healthy Subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2021
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 21, 2021
CompletedFirst Submitted
Initial submission to the registry
December 21, 2021
CompletedFirst Posted
Study publicly available on registry
February 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedMay 7, 2024
May 1, 2024
4.3 years
December 21, 2021
May 5, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Safety as measured by subjects with adverse events
The number of occurrences and incidence are calculated with vital signs, Electrocardiograms, physical examinations, laboratory tests
First dose up to last follow-up visit （85 days after administration）
Secondary Outcomes (4)
Peak concentration (Cmax)
First dose up to last follow-up visit(Day1-Day85）
Peak time (Tmax)
First dose up to last follow-up visit(Day1-Day85）
Area under the Curve (AUC)
First dose up to last follow-up visit(Day1-Day85）
Analysis of immunogenicity
First dose up to last follow-up visit（Day1-Day85）
Study Arms (10)
Recombinant human CTLA-4-FC fusion protein for injection 1mg/kg
EXPERIMENTALRecombinant human CTLA-4-FC fusion protein for injection 1mg/kg single dose usage
Recombinant human CTLA-4-FC fusion protein for injection 2.5mg/kg
EXPERIMENTALRecombinant human CTLA-4-FC fusion protein for injection 2.5mg/kg single dose usage
Recombinant human CTLA-4-FC fusion protein for injection 5mg/kg
EXPERIMENTALRecombinant human CTLA-4-FC fusion protein for injection 5mg/kg single dose usage
Recombinant human CTLA-4-FC fusion protein for injection 7.5mg/kg
EXPERIMENTALRecombinant human CTLA-4-FC fusion protein for injection 7.5mg/kg single dose usage
Recombinant human CTLA-4-FC fusion protein for injection 10mg/kg
EXPERIMENTALRecombinant human CTLA-4-FC fusion protein for injection 10mg/kg single dose usage
Placebo Group:Recombinant human CTLA-4-FC fusion protein for injection 1mg/kg
PLACEBO COMPARATORRecombinant human CTLA-4-FC fusion protein for injection 1mg/kg , i.v. single dose usage.
Placebo Group:Recombinant human CTLA-4-FC fusion protein for injection 2.5mg/kg
PLACEBO COMPARATORRecombinant human CTLA-4-FC fusion protein for injection 2.5mg/kg, i.v. single dose usage.
Placebo Group:Recombinant human CTLA-4-FC fusion protein for injection 5mg/kg
PLACEBO COMPARATORRecombinant human CTLA-4-FC fusion protein for injection 5mg/kg , i.v. single dose usage.
Placebo Group:Recombinant human CTLA-4-FC fusion protein for injection 7.5mg/kg
PLACEBO COMPARATORRecombinant human CTLA-4-FC fusion protein for injection 7.5mg/kg , i.v. single dose usage.
Placebo Group:Recombinant human CTLA-4-FC fusion protein for injection 10mg/kg
PLACEBO COMPARATORRecombinant human CTLA-4-FC fusion protein for injection 10mg/kg , i.v. single dose usage.
Interventions
Recombinant human CTLA-4-FC fusion protein for injection 1mg/kg , i.v. single dose usage.
Recombinant human CTLA-4-FC fusion protein for injection 2.5mg/kg , i.v. single dose usage.
Recombinant human CTLA-4-FC fusion protein for injection 5mg/kg , i.v. single dose usage.
Recombinant human CTLA-4-FC fusion protein for injection 7.5mg/kg , i.v. single dose usage.
Recombinant human CTLA-4-FC fusion protein for injection 10mg/kg , i.v. single dose usage.
Recombinant human CTLA-4-FC fusion protein for injection 1mg/kg
Recombinant human CTLA-4-FC fusion protein for injection 2.5mg/kg
Recombinant human CTLA-4-FC fusion protein for injection 5mg/kg
Recombinant human CTLA-4-FC fusion protein for injection 7.5mg/kg
Recombinant human CTLA-4-FC fusion protein for injection 10mg/kg
Eligibility Criteria
You may qualify if:
- For healthy subjects, health was defined as no abnormality or no abnormality of clinical significance during the screening period, such as medical history, physical examination, electrocardiogram, imaging, and laboratory results;
- Male or female subjects, between 18 and 45 years old (including boundary values);
- Male subjects should weigh no less than 50.0 kg and female subjects should weigh no less than 45.0 kg. Body mass index (BMI) between 19.0 and 25.0 kg/m2 (including critical value),BMI= weight (kg)/ height 2(m2);
- Women of reproductive age must use a reliable method of contraception to avoid pregnancy throughout the study period, 4 weeks prior to administration and 3 months after the end of the study, and fertile men must use a reliable method of contraception to avoid pregnancy during the study period and 3 months after the end of the study;
- Subjects voluntarily participated in the study and signed informed consent.
You may not qualify if:
- Allergic disposition, known or suspected allergy to the test drug or any excipients (disodium hydrogen phosphate and mannitol) or allergy to alcohol/iodine (or iodophor)/ heparin or a history of allergy to any drug, food or pollen, or abnormal serum immunoglobulin E(IgE) tests, conforming to any of these conditions;
- Have a fertility plan or sperm/egg donation plan during the study period and within 3 months after the study; Female subjects have positive urine/blood pregnancy test at baseline, or are lactating;
- Female subjects who took oral contraceptives 30 days before and during the trial, or who used long-acting estrogen or progesterone injections or implants 6 months before and during the trial;
- Patients with central nervous system, cardiovascular system, liver and kidney dysfunction, digestive system, respiratory system and skeletal system diseases (including but not limited to arrhythmia, bradycardia, hypotension, coronary heart disease, bronchial asthma, diabetes, hyperthyroidism, Parkinson's disease, epilepsy, paralysis tremor) Or a history of mental illness and any other diseases or physical conditions that may affect the results of the study;
- Acute chronic bacterial infection within 3 months before enrollment; At the time of enrollment, any symptoms, signs or abnormal laboratory examination suggested the possibility of acute or subacute infection (such as fever, cough, urination, pain, abdominal pain, diarrhea, skin infection, wound, etc.);
- Those who had undergone major surgical operations (craniotomy or thoracotomy) within 4 weeks prior to enrollment, or planned to undergo surgery during the study period, and had unhealed wounds, ulcers or fractures;
- Patients with herpes zoster remission less than 2 months before enrollment;
- Physical examination or ecg reveals abnormal vital signs: heart rate \< 50 beats/min or \> 100 times/min (at least 5 minutes after resting), systolic pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg, or postural hypotension, body temperature (axillary temperature) 37.3;
- Blood routine examination: White blood cell (WBC)\& LT; 3.0 109 / L or \& gt; 9.5 109/L, neutrophils \< 1.5 109/L, platelet \< 100 109/L; Hemoglobin \& Lt; 130g/L(male) or \< 110 g/L (women); Bilirubin \& gt; 1.2 times normal upper limit, serum creatinine \& GT; Upper normal value; AST\> Upper limit of normal,ALT\> Upper limit of normal;
- Subjects at risk for tuberculosis (TB) :1) have a history of active TB infection; 2) Tuberculin test positive; 3) Radiological examination indicated past tuberculosis infection;
- Hiv-ab HCV-AB HBsAg syphilis test results of either positive;
- Persons with a history of drug or alcohol abuse or positive urine drug screening within 6 months prior to screening;
- Those who donated blood within 3 months before enrollment or planned to donate blood during the study period and 1 month after the study ended;
- Patients who had received blood transfusion within 4 weeks prior to enrollment;
- Subjects who were smokers (who had smoked for more than 6 months prior to screening and smoked more than 5 cigarettes per day), consumed 3 cups of coffee or other caffeine-containing beverages, or 5 cups of tea per day;
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University People's Hospital
Beijing, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Huiying Rao, M.D.
Peking University People's Hospital
Central Study Contacts
Yi Fang, Phd
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2021
First Posted
February 25, 2022
Study Start
September 21, 2021
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
May 7, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share