NCT04235933

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

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 17, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 22, 2020

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

3 months

First QC Date

January 6, 2020

Last Update Submit

January 16, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (5)

  • 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.

    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

    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

    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

    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

    Day 0、Day 1、Day 2、Day 3、Day 5、Day 8、Day 15、Day 22、Day 29、Day 43、Day 57

Study Arms (3)

Tai Ai(RC18) 80mg

EXPERIMENTAL

·Experimental: Tai Ai 80mg: Injection: subcutaneous injection on abdomen; Intervention:Biological: RC18

Biological: Tai Ai(RC18) 80mg

Tai Ai(RC18) 160mg

EXPERIMENTAL

·Experimental: RC18 160mg: Injection: subcutaneous injection on abdomen; Intervention:Biological: RC18

Biological: Tai Ai(RC18) 160mg

RC18 240mg

EXPERIMENTAL

·Experimental: RC18 240mg Injection: subcutaneous injection on abdomen; Intervention: Biological: RC18

Biological: RC18 240mg

Interventions

Tai Ai(RC18) 80mgBIOLOGICAL

The patient received one treatment of RC18 80mg in the test group

Tai Ai(RC18) 80mg
Tai Ai(RC18) 160mgBIOLOGICAL

The patient received one treatment of RC18 160mg in the test group

Tai Ai(RC18) 160mg
RC18 240mgBIOLOGICAL

The patient received one treatment of RC18 240mg in the test group

RC18 240mg

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Voluntarily signed the informed consent as applicable to participate in the study, age 18-55, inclusive, male: female=1:1;
  • Body mass index between 18.5-26 kg/m², inclusive, with a body weight ≥50 kg (male), ≥45 kg (female);
  • 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);
  • An understanding, ability, and willingness to fully comply with study procedures and restrictions.

You may not qualify if:

  • 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;
  • 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.);
  • 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;
  • History of allergic to therapeutic or diagnostic protein products, allergic to two or more drugs and/or non-drug factors; suffering from allergic diseases;
  • 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.);
  • Participated an investigational product in recent 3 months;
  • 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;
  • 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;
  • 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.);
  • 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);
  • Positive HIV, HBsAg, Hepatitis C virus, Tubercle Bacillus antibody screen;
  • Researchers believe that there are other factors that are not suitable for participating in the experiment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Remegen，ltd.

Yantai, Shandong, 264006, China

Location

MeSH Terms

Interventions

RC-18

Study Officials

  • Zhijun Li, M.D.

    The First Affiliated Hospital of Bengbu Medical University

    PRINCIPAL INVESTIGATOR

  • Huan Zhou, M.D.

    The First Affiliated Hospital of Bengbu Medical University

    PRINCIPAL INVESTIGATOR

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

January 6, 2020

First Posted

January 22, 2020

Study Start

September 17, 2019

Primary Completion

December 20, 2019

Study Completion

December 20, 2019

Last Updated

January 22, 2020

Record last verified: 2020-01

Locations

CN(1)