HealthyPhase 1NCT05480579
A Study of IBI311 in Healthy Volunteers
A Phase 1 study testing IBI311 in people with Healthy, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
It is designed for Multi-center, double-masked, randomized, placebo- control study with dose escalation phase I trial to evaluate the safety, tolerability, PK and immunogenicity profiles of a single intravenous injection of IBI311 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- IBI311
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2022to 19 Jan 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
- Male or female subjects with age of 18~45 yrs.
- Female subjects of childbearing age or male subjects with childbearing age female partner agree to take effective contraceptive measures from the screening period to 120 days after the end of treatment.
Who cannot join
- Have a history of or any evidence of chronic diseases of liver, kidney, cardiovascular, nervous/mental, digestive tract, respiratory, urinary and endocrine systems.
- Have received prior treatment with another anti-IGF-1R monoclonal antibody.
- History of drug, alcohol, or chemical abuse within 6 months prior to screening.
- History of positive HIV antibody, HCV antibody, Syphilis check, HBV positive during screening period.
- Receipt of a live vaccine within 180 days prior to screening or expected to receive live vaccine during study period.
- History of recurrent significant infection or history of recurrent bacterial infections.
Show all 9Show fewer
- Must not have a history of tinnitus or hearing impairment.
- Must not have received an investigational agent for any condition within 90 days.
- Female volunteers must not be pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, 200041
About this study
Official title: A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of a Single Intravenous Injection IBI311 in Healthy Volunteers
It is designed for Multi-center, double-masked, randomized, placebo- control study with dose escalation phase I trial to evaluate the safety, tolerability, PK and immunogenicity profiles of a single intravenous injection of IBI311 in healthy volunteers.
- Conditions
- Healthy
- Being tested
- placebo, IBI311
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboBiological
Dose4 placebo of single IV injection
IBI311Biological
Dose2 IBI311 of single IV injection
IBI311Biological
Dose4 IBI311 of single IV injection
placeboBiological
Dose3 placebo of single IV injection
placeboBiological
Dose1 placebo of single IV injection
IBI311Biological
Dose1 IBI311 of single IV injection
IBI311Biological
Dose 3 IBI311 of single IV injection
placeboBiological
Dose2 placebo of single IV injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: treated with different doses of single intravenous injection of IBI311 | Experimental | Not described Receives: Biological: IBI311 |
| Cohort 1: placebo group | Placebo comparator | Not described Receives: Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, relatedness and severity of all adverse events, treatment emergent adverse events and serious adverse events
Measured: Up to 16 weeks
Secondary outcomes (4)
maximum concentration (Cmax）
PK parameters maximum concentration (Cmax） of IBI311
Measured: Up to 16 weeks.
area under the curve (AUC)
PK parameters area under the curve (AUC) of IBI311
Measured: Up to 16 weeks.
half-life (t1/2)
PK parameters half-life (t1/2) of IBI311
Measured: Up to 16 weeks.
the incidence of ADA
Positive rate of anti-drug antibody
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start10 Aug 2022
- Primary completion23 Nov 2022
- Study completion19 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yongfang Yuan, Ph D., Principal investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480579
- Sponsor's protocol ID
- CIBI311A101
- Status last verified
- Oct 2023
- First submitted
- 15 Jul 2022
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of a Single Intravenous Injection IBI311 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05480579
- Acronym / sponsor ID
- CIBI311A101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 23 Nov 2022 (actual)
- Study completion
- 19 Jan 2023 (actual)
- First posted
- 29 Jul 2022 (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.
It is designed for Multi-center, double-masked, randomized, placebo- control study with dose escalation phase I trial to evaluate the safety, tolerability, PK and immunogenicity profiles of a single intravenous injection of IBI311 in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: treated with different doses of single intravenous injection of IBI311 | Experimental | Biological: IBI311 |
| Cohort 1: placebo group | Placebo comparator | Biological: placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
- Male or female subjects with age of 18~45 yrs.
- Female subjects of childbearing age or male subjects with childbearing age female partner agree to take effective contraceptive measures from the screening period to 120 days after the end of treatment.
Key exclusion criteria (9 listed)
- Have a history of or any evidence of chronic diseases of liver, kidney, cardiovascular, nervous/mental, digestive tract, respiratory, urinary and endocrine systems.
- Have received prior treatment with another anti-IGF-1R monoclonal antibody.
- History of drug, alcohol, or chemical abuse within 6 months prior to screening.
- History of positive HIV antibody, HCV antibody, Syphilis check, HBV positive during screening period.
- Receipt of a live vaccine within 180 days prior to screening or expected to receive live vaccine during study period.
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 |
|---|---|---|
| placeboDose4 placebo of single IV injection | Biological | Cohort 1: placebo group |
| IBI311Dose2 IBI311 of single IV injection | Biological | Cohort 1: treated with different doses of single intravenous injection of IBI311 |
| IBI311Dose4 IBI311 of single IV injection | Biological | Cohort 1: treated with different doses of single intravenous injection of IBI311 |
| placeboDose3 placebo of single IV injection | Biological | Cohort 1: placebo group |
| placeboDose1 placebo of single IV injection | Biological | Cohort 1: placebo group |
| IBI311Dose1 IBI311 of single IV injection | Biological | Cohort 1: treated with different doses of single intravenous injection of IBI311 |
| IBI311Dose 3 IBI311 of single IV injection | Biological | Cohort 1: treated with different doses of single intravenous injection of IBI311 |
| placeboDose2 placebo of single IV injection | Biological | Cohort 1: placebo group |
Primary outcome
Incidence, relatedness and severity of all adverse events, treatment emergent adverse events and serious adverse events
Time frame: Up to 16 weeks
4 secondary outcomes
maximum concentration (Cmax）
Time frame: Up to 16 weeks.
area under the curve (AUC)
Time frame: Up to 16 weeks.
half-life (t1/2)
Time frame: Up to 16 weeks.
the incidence of ADA
Time frame: Up to 16 weeks
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 11 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Yongfang Yuan, Ph D. principal investigator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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 IBI311 in people with Healthy, 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 9 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 11 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. Some participants in this study may receive a placebo. 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, relatedness and severity of all adverse events, treatment emergent adverse events and serious adverse events (time frame: Up to 16 weeks). 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 11 Oct 2023.