A Phase I Study of TACI-antibody Fusion Protein Injection (RC18) in Healthy Adult Chinese Subjects

A Phase I, Open-label Study to Evaluate the Pharmacokinetics, and Pharmacodynamics of a Single Dose of Tai Ai Injection in Healthy Adult Chinese Subjects

to evaluate the pharmacokinetics, and pharmacodynamics of a single dose of Tai Ai injection in healthy adult Chinese subjects

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: Tai Ai(RC18) 80mg; Biological: Tai Ai(RC18) 160mg; Biological: RC18 240mg

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Yantai, Shandong, China, 264006
      • Remegen，ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Voluntarily signed the informed consent as applicable to participate in the study, age 18-55, inclusive, male: female=1:1;
2. Body mass index between 18.5-26 kg/m², inclusive, with a body weight ≥50 kg (male), ≥45 kg (female);
3. Considered "healthy" by the investigator. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, as well as a complete physical examination including vital signs, 12-lead ECG, X-ray examination, infectious disease examination, peripheral blood cell count, platelet aggregation and coagulation function, blood chemistry, urine routine and stool routine ( include occult blood);
4. An understanding, ability, and willingness to fully comply with study procedures and restrictions.

Exclusion Criteria:

1. History of any hematological, digestive system, respiratory, cardiovascular, renal, neurological, psychiatric disease, metabolic disorders or tumor, which could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments;
2. History of abnormal bleeding or coagulation disorders (e.g. easy bruising, gum bleeding, prolonged bleeding after tooth extraction, joint hemorrhage; anemia in recent 1 year caused by menorrhagia, postpartum hemorrhage, vitamin K deficiency, haemorrhagic diseases caused by acquired coagulation factor antibodies, trauma or post-operative bleeding, etc.);
3. Pregnant or lactating female during screening period; subjects and their partners did not agree to take effective contraceptive measures (such as intrauterine devices, contraceptives or condoms) throughout the study period and within 30 days after the end of the visit period;
4. History of allergic to therapeutic or diagnostic protein products, allergic to two or more drugs and/or non-drug factors; suffering from allergic diseases;
5. History of surgery within six months before signing the informed consent; Willing to undergo surgery within two weeks after the end of the trial (including cosmetic surgery, dental surgery, oral surgery, etc.);
6. Participated an investigational product in recent 3 months;
7. Current use of any prescription or over-the-counter (herbal, vitamins, or healthcare products). Current use is defined as use within 14 days or PK equivalent of 5 half-lives, whichever is longer;
8. History of Bleeding or donated more than 400ml blood 3 months before screening period, or plan to denote blood within 1 month after the trial;
9. Consume more tobacco or alcohol (≥14 units of alcohol per week: one standard unit contains 14g of alcohol, equals to 360ml of beer, 45ml of 40% liquor or 150ml of wine; smokers with more than 5 cigarettes per day.);
10. Consume excessive caffeine-containing beverages, foods that may affect drug metabolism within four weeks before signing informed consent: coffee (≥1100 mL per day), tea (≥2200 mL per day), cola (≥2200 mL per day), energy drinks (≥1100 mL per day), chocolate (≥510 g per day);
11. Positive HIV, HBsAg, Hepatitis C virus, Tubercle Bacillus antibody screen;
12. Researchers believe that there are other factors that are not suitable for participating in the experiment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Tai Ai(RC18) 80mg; ·Experimental: Tai Ai 80mg: Injection: subcutaneous injection on abdomen; Intervention:Biological: RC18	Biological: Tai Ai(RC18) 80mg; The patient received one treatment of RC18 80mg in the test group
EXPERIMENTAL: Tai Ai(RC18) 160mg; ·Experimental: RC18 160mg: Injection: subcutaneous injection on abdomen; Intervention:Biological: RC18	Biological: Tai Ai(RC18) 160mg; The patient received one treatment of RC18 160mg in the test group
EXPERIMENTAL: RC18 240mg; ·Experimental: RC18 240mg Injection: subcutaneous injection on abdomen; Intervention: Biological: RC18	Biological: RC18 240mg; The patient received one treatment of RC18 240mg in the test group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C-max	Maximum observed plasma concentration	Day 0、Day 1、Day 2、Day 3、Day 5、Day 8、Day 15、Day 22、Day 29、Day 43、Day 57
T-max	Time to reach maximum observed plasma concentration	Day 0、Day 1、Day 2、Day 3、Day 5、Day 8、Day 15、Day 22、Day 29、Day 43、Day 57
T1/2	apparent terminal half-life	Day 0、Day 1、Day 2、Day 3、Day 5、Day 8、Day 15、Day 22、Day 29、Day 43、Day 57
AUC0-t	area under the plasma concentration time curve from time 0 to the time of last observed quantifiable concentration	Day 0、Day 1、Day 2、Day 3、Day 5、Day 8、Day 15、Day 22、Day 29、Day 43、Day 57
AUC0-∞	Area under the plasma concentration-time curve from time 0 extrapolated to infinity	Day 0、Day 1、Day 2、Day 3、Day 5、Day 8、Day 15、Day 22、Day 29、Day 43、Day 57

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of AEs (adverse events).Through observing number of total AEs and number of subjects with AEs and other factors of AEs ，to evaluate the safety and tolerance of healthy subjects.	Occurrence of all adverse events from signing of informed consent through end of study treatment.	Day 0、Day 1、Day 2、Day 3、Day 5、Day 8、Day 15、Day 22、Day 29、Day 43、Day 57
Evaluation of Vital Signs	Through observing the normal and abnormal conditions of axillary temperature to evaluate the safety and tolerance of healthy subjects. Axillary temperature's normal ：≥36 and ≤37°C. Clinical significance of abnormal values as judged by the investigator	Day 0、Day 1、Day 2、Day 3、Day 5、Day 8、Day 15、Day 22、Day 29、Day 43、Day 57
Evaluation of Vital Signs	Through observing the normal and abnormal conditions of Pulse rate to evaluate the safety and tolerance of healthy subjects. Pulse rate's normal ：≥60 and ≤100. Clinical significance of abnormal values as judged by the investigator	Day 0、Day 1、Day 2、Day 3、Day 5、Day 8、Day 15、Day 22、Day 29、Day 43、Day 57
Evaluation of Vital Signs	Through observing the normal and abnormal conditions of Blood pressure (both systolic and diastolic) to evaluate the safety and tolerance of healthy subjects. systolic pressure 's normal： ≥90 and ≤139 ； diastolic pressure's normal ：≥60 and ≤89. Clinical significance of abnormal values as judged by the investigator	Day 0、Day 1、Day 2、Day 3、Day 5、Day 8、Day 15、Day 22、Day 29、Day 43、Day 57
Evaluation of Vital Signs	Through observing the normal and abnormal conditions of respiration to evaluate the safety and tolerance of healthy subjects. respiration's normal ：≥10 and ≤24. Clinical significance of abnormal values as judged by the investigator	Day 0、Day 1、Day 2、Day 3、Day 5、Day 8、Day 15、Day 22、Day 29、Day 43、Day 57

Collaborators and Investigators

• Sponsor: RemeGen Co., Ltd.
• Investigators: Principal Investigator: Zhijun Li, M.D., First Affiliated Hospital Bengbu Medical College; Principal Investigator: Huan Zhou, M.D., First Affiliated Hospital Bengbu Medical College

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 17, 2019
• Primary Completion (ACTUAL): December 20, 2019
• Study Completion (ACTUAL): December 20, 2019

Study Registration Dates

• First Submitted: January 6, 2020
• First Submitted That Met QC Criteria: January 16, 2020
• First Posted (ACTUAL): January 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 16, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 18C015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No