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Healthy SubjectsPhase 1NCT05688124

A Study of IBI351 in Healthy Subjects

A Phase 1 study testing IBI351 and Esomeprazole in people with Healthy Subjects, run by Innovent Biologics (Suzhou) 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

This is a randomized, open-label, two-cycle clinical study to evaluate the drug interaction, food effect and pharmacokinetics of IBI351 and esomeprazole in healthy subjects. A total of two cohorts were planned to be enrolled in each cohort. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
IBI351 and Esomeprazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
16 Feb 2023to 16 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 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • voluntarily sign the informed consent form before the trial, fully understand the content, process and possible adverse reactions of the trial, and be able to complete the study according to the requirements of the trial protocol.
  • healthy male subjects aged 18 to 45 years (including both ends) at the time of signing informed consent.
  • body weight is not less than 50 kg, and body mass index (BMI) is within the range of 19 ~ 26 kg/m2 (including cut-off value).

Who cannot join

  • have taken any products containing alcohol or have a positive alcohol breath test (≥ 20 mg/100 ml) within 24 hours before taking study medication.
  • hepatitis B surface antigen HBsAg positive.
  • hepatitis C virus antibody positive.
  • positive AIDS antigen/antibody or Treponema pallidum antibody

Trial locations and contacts

1 site in 1 country.

China1 site

  • the First Affiliated Hospital of Suzhou University

    Suzhou, Jiangsu, 215006

Other trials in China

About this study

Official title: A Randomized, Open-label, Two-cycle Clinical Study to Evaluate the Drug Interaction, Food Effect and Pharmacokinetics of IBI351 With Esomeprazole in Healthy Subjects

This is a randomized, open-label, two-cycle clinical study to evaluate the drug interaction, food effect and pharmacokinetics of IBI351 and esomeprazole in healthy subjects. A total of two cohorts were planned to be enrolled in each cohort. Cohort 1: This cohort investigated the effect of esomeprazole on the pharmacokinetics of IBI351 in healthy subjects. Cohort 2: This cohort investigated the effect of food on the pharmacokinetics of IBI351 in healthy subjects.

Being tested
IBI351, Esomeprazole

What participants receive

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

  • IBI351Drug

    IBI351 is administered orally

  • EsomeprazoleDrug

    Esomeprazole is administered orally

Study groups in NCT05688124
Study groupRoleWhat they receive
IBI351OtherThis cohort investigated the effect of food on the pharmacokinetics of IBI351 in healthy subjects. In a double-crossover design, subjects were enrolled and randomly divided into two test groups A and B. Group A: IBI351 was orally administered to subjects in this group on an empty stomach on Day 1, followed by a high-fat meal on Day 4. Group B: IBI351 was orally administered to subjects in this group after a high-fat meal on Day 1 followed by an empty stomach on Day 4.
Receives: Drug: IBI351
IBI351+EsomeprazoleOtherEnrolled subjects were orally administered IBI351 with recommended dose on an empty stomach. Esomeprazole were administered orally.
Receives: Drug: IBI351; Drug: Esomeprazole

What is being measured

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

  1. maximum concentrations (Cmax ) for plasma

    Measured: approximately 10 days after first dose

  2. area under the curve from time 0 to infinity(AUC0-inf) for plasma

    Measured: approximately 10 days after first dose

  3. area under the curve from time 0 to the last time point (AUC0-t) for plasma

    Measured: approximately 10 days after first dose

Secondary outcomes (11)

  1. time-to-maximum concentration (Tmax) for total plasma

    Measured: approximately 10 days after first dose

  2. half-life (t1/2) for total plasma

    Measured: approximately 10 days after first dose

  3. apparent clearance (CL/F) for total plasma

    Measured: approximately 10 days after first dose

  4. the time prior to the first measurable (non-zero) concentration （tlag）

    Measured: approximately 10 days after first dose

  5. apparent volume of distribution(Vz/F) for total plasma

    Measured: approximately 10 days after first dose

  6. adverse events

    Measured: approximately 10 days after first dose

  7. number of participants with abnormal ECG readings

    Measured: approximately 10 days after first dose

  8. number of participants with abnormal hematology test results

    Measured: approximately 10 days after first dose

  9. number of participants with abnormal chemisty test results

    Measured: approximately 10 days after first dose

  10. number of participants with abnormal vital signs

    Measured: approximately 10 days after first dose

  11. number of participants with abnormal physical examination

    Measured: approximately 10 days after first dose

Timeline

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

  1. First posted18 Jan 2023
  2. Study start16 Feb 2023
  3. Primary completion16 Oct 2023
  4. Study completion16 Oct 2023

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05688124
Sponsor's protocol ID
CIBI351P001
Status last verified
Oct 2023
First submitted
12 Dec 2022
Last updated
24 Oct 2023
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 IBI351 and Esomeprazole in people with Healthy Subjects, run by Innovent Biologics (Suzhou) 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 3 inclusion and 4 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 24 Oct 2023. 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?

maximum concentrations (Cmax ) for plasma (time frame: approximately 10 days after first dose). The study lists 3 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 NCT05688124.

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 24 Oct 2023.

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