Healthy SubjectsPhase 1NCT06110338
Safety and Tolerance Study of IBI355 in Health Volunteers
A Phase 1 study testing IBI355 in people with Healthy Subjects, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This study is being done to find out if IBI355 is safe and tolerance in health volunteers. The study will test increasing single doses of IBI355 given to adult health volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- IBI355
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2023to 23 Sep 2024
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who have decided to voluntarily participate in the study and provided a written consent regarding observance of precautions after having been informed of and having fully understood the objectives, methods, and effects of the study in detail;
- Healthy male and female aged 18 years or above ;
- Subject with a Body Mass Index (BMI)* between 18.5 and 28.0 kg/㎡;
- subjects with a normal laboratory examination，ECG， X-ray.
Who cannot join
- Subjects with a history of allergy；
- Subjects participated in the other clinical trail in 1 month or less than 5 t1/2 since the previous clinical trial (which is longer)；
- Subjects with an infection requiring systemic medication was present within 30 days prior to randomization;
- HIV-Ab、RPR、HCV-Ab、HBV、HBeAg or HBcAb, one of them positive;
- There have a clinical or imaging evidence that the subject with active tuberculosis, or there is evidence that the subject is in the incubation period for tuberculosis;
- Patients with a history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders and other systemic diseases;
- Subject with a hcg positive;
- Patients with a history of neuropsychiatry or who are considered unfit to participate in this clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-blind Study to Evaluate the Safety and Tolerability of a Single-dose Administration of IBI355 in Health Adults
This study is being done to find out if IBI355 is safe and tolerance in health volunteers. The study will test increasing single doses of IBI355 given to adult health volunteers. The goal is to confirmed the safety of the highest dose of IBI355 or to find out the highest dose of IBI35 that can be given to health volunteer that dose not cause unacceptable side effects. Different dose regimens will be evaluated. The pharmacokinetics and ADA of IBI355 will also be evaluated.
- Conditions
- Healthy Subjects
- Being tested
- placebo, IBI355
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
placebo iv. once.
IBI355Drug
IBI355 iv. once.
| Study group | Role | What they receive |
|---|---|---|
| IBI355 dose 1 | Experimental | IBI355 0.3mg/kg and placebo will be given to the subjects (3:2) Receives: Drug: placebo; Drug: IBI355 |
| IBI355 dose 4 | Experimental | IBI355 7.5mg/kg and placebo will be given to the subjects (6:2) Receives: Drug: placebo; Drug: IBI355 |
| IBI355 dose 6 | Experimental | IBI355 25mg/kg and placebo will be given to the subjects (6:2) Receives: Drug: placebo; Drug: IBI355 |
| IBI355 dose 7 | Experimental | IBI355 35mg/kg and placebo will be given to the subjects (6:2) Receives: Drug: placebo; Drug: IBI355 |
| IBI355 dose 2 | Experimental | IBI355 1mg/kg and placebo will be given to the subjects (6:2) Receives: Drug: placebo; Drug: IBI355 |
| IBI355 dose 3 | Experimental | IBI355 3mg/kg and placebo will be given to the subjects (6:2) Receives: Drug: placebo; Drug: IBI355 |
| IBI355 dose 5 | Experimental | IBI355 15mg/kg and placebo will be given to the subjects (6:2) Receives: Drug: placebo; Drug: IBI355 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AE、SAE after receiving IBI 355
Measured: week 0-12
Secondary outcomes (1)
Area Under Curve, (AUC）、Maximum serum concentration of drug(Cmax）、Clearance (CL）、Apparent volume of distribution(V） and Half- life(t1/2）of IBI355
Measured: week 0-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start30 Oct 2023
- Primary completion20 Sep 2024
- Study completion23 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110338
- Sponsor's protocol ID
- CIBI355A101CN
- Status last verified
- Oct 2024
- First submitted
- 26 Oct 2023
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-blind Study to Evaluate the Safety and Tolerability of a Single-dose Administration of IBI355 in Health Adults
- ClinicalTrials.gov ID
- NCT06110338
- Acronym / sponsor ID
- CIBI355A101CN
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 23 Sep 2024 (actual)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to find out if IBI355 is safe and tolerance in health volunteers. The study will test increasing single doses of IBI355 given to adult health volunteers. The goal is to confirmed the safety of the highest dose of IBI355 or to find out the highest dose of IBI35 that can be given to health volunteer that dose not cause unacceptable side effects. Different dose regimens will be evaluated. The pharmacokinetics and ADA of IBI355 will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| IBI355 dose 1 | Experimental | Drug: placebo, Drug: IBI355IBI355 0.3mg/kg and placebo will be given to the subjects (3:2) |
| IBI355 dose 4 | Experimental | Drug: placebo, Drug: IBI355IBI355 7.5mg/kg and placebo will be given to the subjects (6:2) |
| IBI355 dose 6 | Experimental | Drug: placebo, Drug: IBI355IBI355 25mg/kg and placebo will be given to the subjects (6:2) |
| IBI355 dose 7 | Experimental | Drug: placebo, Drug: IBI355IBI355 35mg/kg and placebo will be given to the subjects (6:2) |
| IBI355 dose 2 | Experimental | Drug: placebo, Drug: IBI355IBI355 1mg/kg and placebo will be given to the subjects (6:2) |
| IBI355 dose 3 | Experimental | Drug: placebo, Drug: IBI355IBI355 3mg/kg and placebo will be given to the subjects (6:2) |
| IBI355 dose 5 | Experimental | Drug: placebo, Drug: IBI355IBI355 15mg/kg and placebo will be given to the subjects (6:2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects who have decided to voluntarily participate in the study and provided a written consent regarding observance of precautions after having been informed of and having fully understood the objectives, methods, and effects of the study in detail;
- Healthy male and female aged 18 years or above ;
- Subject with a Body Mass Index (BMI)* between 18.5 and 28.0 kg/㎡;
- subjects with a normal laboratory examination，ECG， X-ray.
Key exclusion criteria (8 listed)
- Subjects with a history of allergy；
- Subjects participated in the other clinical trail in 1 month or less than 5 t1/2 since the previous clinical trial (which is longer)；
- Subjects with an infection requiring systemic medication was present within 30 days prior to randomization;
- HIV-Ab、RPR、HCV-Ab、HBV、HBeAg or HBcAb, one of them positive;
- There have a clinical or imaging evidence that the subject with active tuberculosis, or there is evidence that the subject is in the incubation period for tuberculosis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboplacebo iv. once. | Drug | IBI355 dose 1, IBI355 dose 2, IBI355 dose 3, IBI355 dose 4, IBI355 dose 5, IBI355 dose 6, IBI355 dose 7 |
| IBI355IBI355 iv. once. | Drug | IBI355 dose 1, IBI355 dose 2, IBI355 dose 3, IBI355 dose 4, IBI355 dose 5, IBI355 dose 6, IBI355 dose 7 |
Primary outcome
Incidence of AE、SAE after receiving IBI 355
Time frame: week 0-12
1 secondary outcome
Area Under Curve, (AUC）、Maximum serum concentration of drug(Cmax）、Clearance (CL）、Apparent volume of distribution(V） and Half- life(t1/2）of IBI355
Time frame: week 0-12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IBI355 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 4 inclusion and 8 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 21 Oct 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 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?
Incidence of AE、SAE after receiving IBI 355 (time frame: week 0-12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2024.