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Advanced TumorsPhase 1NCT05799183

A SHR-1210 BE Study on Healthy Subjects

A Phase 1 study testing SHR-1210 in people with Advanced Tumors, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to assess the bioequivalence of SHR-1210 before and after process changes. Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Advanced Tumors
What is being tested?
SHR-1210
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
4 Jul 2023to 12 Oct 2023
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 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male subjects aged ≥ 18;
  • Weigh at least 50 kg, and have a body mass index (BMI) ≥ 19 and ≤28 kg/m2;
  • Subjects agree to use reliable contraceptive measures (e.g., abstinence, sterilization, contraceptives, injectable contraceptives methylprogesterone or subcutaneous implantation in the duration of the study and for 4 months after the study drug infusion);
  • Sign the informed consent before the trial, and fully understand the content, process and possible adverse reactions of the trial. Must be able to communicate with the investigator, understand and comply with all study requirements.

Who cannot join

  • Those with a history of chronic liver, kidney, cardiovascular, neurological/psychiatric, digestive tract, respiratory, urinary, endocrine and other systemic diseases;
  • Those with a history of autoimmune diseases;
  • Regular drinkers in the 6 months prior to the trial had an average daily alcohol intake of more than 15 g (equivalent to 145 mL of wine, 450 mL of beer, or 43 mL of liquor with 40% alcohol content);
  • Those who are suspected or confirmed to be allergic or have had serious drug or food allergic reactions in the past, have a clear history of allergies and/or are allergic to the research drug or its ingredients;
  • Have used any drug (including Chinese medicine and vitamins) within 2 weeks before screening, or the last dose is less than 5 half-lives of the drug from the test administration date, whichever is longer;
  • Have used of anti-PD-1/PD-L1 drugs;
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  • Those who have participated in other interventional clinical trials within 3 months before screening;
  • ≥400 ml of blood loss, blood donation or receiving any blood product transfusion within 3 months before screening;
  • Those who have undergone major surgery or hospitalized for illness within 3 months before screening;
  • Those who have received live vaccines within 6 months prior to screening, or who are expected to receive live vaccines during the study period;
  • Those with a history of drug abuse or positive drug screening results within 12 months prior to screening;
  • Those who have abnormalities in vital signs, physical examination, and laboratory tests during the screening period and are judged to be clinically significant by the study physician (Note: If there is an abnormality and the study doctor judges that it has clinical significance, if it is within the normal range after re-examination, it can also be enrolled);
  • There are abnormalities in the ECG during the screening period (such as QTcF≥ 450ms, shortened or prolonged PR interval, second-degree and third-degree atrioventricular block, pre-excitation syndrome, etc.) and are judged by the study doctor to have clinical significance;
  • Chest x-ray (positive and lateral position) or lung CT during the screening period is abnormal and judged by the study doctor to be clinically significant;
  • History of needle sickness and blood sickness; or those with poor vascular conditions, unable to retain implanted needles or unable to tolerate venipuncture blood collection;
  • Those that the investigator believes are not suitable to participate in this clinical trial for other reasons.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410023

Other trials in China

About this study

Official title: A Bioequivalence Study of SHR-1210 in Healthy Subjects

The purpose of this study is to assess the bioequivalence of SHR-1210 before and after process changes.

Conditions
Advanced Tumors
Being tested
SHR-1210

What participants receive

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

  • SHR-1210Drug

    Subjects will receive treatment SHR-1210 before process changes 20 mg

  • SHR-1210Drug

    Subjects will receive treatment SHR-1210 after process changes 20 mg

Study groups in NCT05799183
Study groupRoleWhat they receive
Pre-test: ARM AExperimentalSHR-1210 before process changes 20 mg
Receives: Drug: SHR-1210
Pre-test: ARM BExperimentalSHR-1210 after process changes 20 mg
Receives: Drug: SHR-1210
Formal Test: ARM AExperimentalSHR-1210 before process changes 20 mg
Receives: Drug: SHR-1210
Formal Test: ARM BExperimentalSHR-1210 after process changes 20 mg
Receives: Drug: SHR-1210

What is being measured

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

  1. Pre-test: Incidence and severity of AE/SAE/AESI (rated based on CTCAE v5.0)

    Measured: Day-1 to Day 46

  2. Formal Test: Pharmacokinetics parameters of SHR-1210 before and after process changes in the fed state: AUC0-inf

    Measured: Based on pre-dose, 0.25-192 hours post-dose sampling times on Day 1 ~ Day 4 and Day 6 ~ Day 9

  3. Formal Test: Pharmacokinetics parameters of SHR-1210 before and after process changes in the fed state: the geometric mean ration

    Measured: Based on pre-dose, 0.25-192 hours post-dose sampling times on Day 1 ~ Day 4 and Day 6 ~ Day 9

  4. Formal Test: Pharmacokinetics parameters of SHR-1210 before and after process changes in the fed state: 90% confidence interval (90% CI) of AUC0-inf

    Measured: Based on pre-dose, 0.25-192 hours post-dose sampling times on Day 1 ~ Day 4 and Day 6 ~ Day 9

Secondary outcomes (9)

  1. Pre-test: Inter-individual coefficient of variation (CV) of the AUC0-inf of SHR-1210

    Measured: Based on pre-dose, 0.25-192 hours post-dose sampling times on Day 1 ~ Day 4 and Day 6 ~ Day 9

  2. Formal Test: Other Pharmacokinetics parameters of SHR-1210 before and after process changes in the fed state: Cmax

    Measured: Based on pre-dose, 0.25-192 hours post-dose sampling times on Day 1 ~ Day 4 and Day 6 ~ Day 9

  3. Formal Test: Other Pharmacokinetics parameters of SHR-1210 before and after process changes in the fed state: AUC0-t

    Measured: Based on pre-dose, 0.25-192 hours post-dose sampling times on Day 1 ~ Day 4 and Day 6 ~ Day 9

  4. Formal Test: Other Pharmacokinetics parameters of SHR-1210 before and after process changes in the fed state: Tmax

    Measured: Based on pre-dose, 0.25-192 hours post-dose sampling times on Day 1 ~ Day 4 and Day 6 ~ Day 9

  5. Formal Test: Other Pharmacokinetics parameters of SHR-1210 before and after process changes in the fed state: t1/2

    Measured: Based on pre-dose, 0.25-192 hours post-dose sampling times on Day 1 ~ Day 4 and Day 6 ~ Day 9

  6. Formal Test: Other Pharmacokinetics parameters of SHR-1210 before and after process changes in the fed state: CL

    Measured: Based on pre-dose, 0.25-192 hours post-dose sampling times on Day 1 ~ Day 4 and Day 6 ~ Day 9

  7. Formal Test: Other Pharmacokinetics parameters of SHR-1210 before and after process changes in the fed state: Vss

    Measured: Based on pre-dose, 0.25-192 hours post-dose sampling times on Day 1 ~ Day 4 and Day 6 ~ Day 9

  8. Formal Test: The incidence of anti-drug antibody (ADA) and neutralizing antibody (Nab) for SHR-1210

    Measured: Based on sampling times pre-dose on Day1, post-dose on Day 9 and Day 16

  9. Formal Test: Incidence and severity of adverse events (rated based on CTCAE 5.0）

    Measured: Day-1, Day 1 to Day 46±7

Timeline

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

  1. First posted5 Apr 2023
  2. Study start4 Jul 2023
  3. Primary completion12 Oct 2023
  4. Study completion12 Oct 2023

Why it stopped: Sponsor's R\&D Strategy adjusted

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is divided into two parts: pre-test and formal test. Each experiment will have two independent cohorts of subjects who will receive the treatment(SHR-1210 before process changes and SHR-1210 after process changes，respectively), and each cohort will be followed by 192 hours of blood sampling for pharmacokinetic assessments, with safety and tolerability.
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05799183
Sponsor's protocol ID
SHR-1210-I-105
Status last verified
Sep 2023
First submitted
13 Mar 2023
Last updated
31 Dec 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SHR-1210 in people with Advanced Tumors, run by Jiangsu HengRui Medicine 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 16 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: stopped early, as of the sponsor's last update on 31 Dec 2024. 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 was stopped early (reason given: Sponsor's R\&D Strategy adjusted). Results are not available in the source record.

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?

Pre-test: Incidence and severity of AE/SAE/AESI (rated based on CTCAE v5.0) (time frame: Day-1 to Day 46). The study lists 4 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 NCT05799183.

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 31 Dec 2024.

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