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HealthyPhase 1NCT04235933

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

A Phase 1 study testing Tai Ai(RC18) 80mg, Tai Ai(RC18) 160mg and RC18 240mg in people with Healthy, run by RemeGen Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

to evaluate the pharmacokinetics, and pharmacodynamics of a single dose of Tai Ai injection in healthy adult Chinese subjects Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Tai Ai(RC18) 80mg, Tai Ai(RC18) 160mg and RC18 240mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
17 Sep 2019to 20 Dec 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Remegen，ltd.

    Yantai, Shandong, 264006

Other trials in China

About this study

Official title: 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

Conditions
Healthy
Being tested
Tai Ai(RC18) 80mg, Tai Ai(RC18) 160mg, RC18 240mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tai Ai(RC18) 80mgBiological

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

  • Tai Ai(RC18) 160mgBiological

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

  • RC18 240mgBiological

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

Study groups in NCT04235933
Study groupRoleWhat they receive
Tai Ai(RC18) 80mgExperimental·Experimental: Tai Ai 80mg: Injection: subcutaneous injection on abdomen; Intervention:Biological: RC18
Receives: Biological: Tai Ai(RC18) 80mg
Tai Ai(RC18) 160mgExperimental·Experimental: RC18 160mg: Injection: subcutaneous injection on abdomen; Intervention:Biological: RC18
Receives: Biological: Tai Ai(RC18) 160mg
RC18 240mgExperimental·Experimental: RC18 240mg Injection: subcutaneous injection on abdomen; Intervention: Biological: RC18
Receives: Biological: RC18 240mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. C-max

    Maximum observed plasma concentration

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

  2. T-max

    Time to reach maximum observed plasma concentration

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

  3. T1/2

    apparent terminal half-life

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

  4. AUC0-t

    area under the plasma concentration time curve from time 0 to the time of last observed quantifiable concentration

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

  5. AUC0-∞

    Area under the plasma concentration-time curve from time 0 extrapolated to infinity

    Measured: 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)

  1. 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.

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

  2. 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

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

  3. 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

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

  4. 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

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

  5. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2020
  2. Study start17 Sep 2019
  3. Primary completion20 Dec 2019
  4. Study completion20 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04235933
Sponsor's protocol ID
18C015
Status last verified
Jan 2020
First submitted
6 Jan 2020
Last updated
22 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tai Ai(RC18) 80mg, Tai Ai(RC18) 160mg and RC18 240mg in people with Healthy, run by RemeGen Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

C-max (time frame: Day 0、Day 1、Day 2、Day 3、Day 5、Day 8、Day 15、Day 22、Day 29、Day 43、Day 57). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04235933.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.

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