Overweight/ObesityPhase 1NCT04773977
Clinical Study of IBI362 in Healthy Chinese Male Subjects
A Phase 1 study testing IBI362 liquid formulation and IBI362 lyophilized powder in people with Overweight/Obesity, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This is a study to evaluate the pharmacokinetic characteristics and safety of IBI362 lyophilized powder and IBI362 liquid formulation in healthy Chinese male subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight/Obesity
- What is being tested?
- IBI362 liquid formulation and IBI362 lyophilized powder
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 3 Mar 2021to 17 Jun 2021
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20 years old≤ Healthy males≤45 years old
- 19 kilograms per meter squared (kg/m²)≤Body Mass Index≤26 kg/m²
- Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff
Who cannot join
- Subjects who have previously completed or discontinued from this study, or who have used IBI362.
- Abnormal vital signs and physical examination during the screening period;
- Having cardiovascular, respiratory, liver, kidney, digestive, endocrine, hematologic, neurological, or muscle degenerative diseases can significantly affect drug absorption, metabolism, or elimination, or participation in the study increases risk or interferes with data interpretation.
- Have a previous or current mental illness.
- A family history of medullary thyroid carcinoma or multiple endocrine tumor syndrome type 2.
- There are other factors judged by the investigators that are not suitable for inclusion in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study to Evaluate the Pharmacokinetics and Safety of IBI362 Lyophilized Powder and IBI362 Liquid Formulation in Healthy Chinese Male Subjects
This is a study to evaluate the pharmacokinetic characteristics and safety of IBI362 lyophilized powder and IBI362 liquid formulation in healthy Chinese male subjects.
Read the detailed description
Pharmacokinetic；Safety
- Conditions
- Overweight/Obesity
- Being tested
- IBI362 liquid formulation, IBI362 lyophilized powder
- Keywords
- Pharmacokinetic, Safety
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI362 liquid formulationDrug
Administered by subcutaneous injection
IBI362 lyophilized powderDrug
Administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| IBI362 liquid formulation | Experimental | Participants received single subcutaneous injection of IBI362 liquid formulation Receives: Drug: IBI362 liquid formulation |
| IBI362 lyophilized powder | Experimental | Participants received single subcutaneous injection of IBI362 lyophilized powder Receives: Drug: IBI362 lyophilized powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the PK parameters of IBI362 in healthy Chinese male subjects
Peak Plasma Concentration (Cmax)
Measured: From the first dose of study drug until 8 weeks
Evaluate the PK parameters of IBI362 in healthy Chinese male subjects
Area under the plasma concentration versus time curve (AUC)
Measured: From the first dose of study drug until 8 weeks
Secondary outcomes (1)
Number of Participants With Adverse Events
The relationship of each adverse event to the investigational product was assessed by the investigator.
Measured: From the first dose of study drug until 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start3 Mar 2021
- Primary completion9 Mar 2021
- Study completion17 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight/ObesityStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jian Li, Principal investigator, The Sceond Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773977
- Sponsor's protocol ID
- CIBI362B102
- Status last verified
- Mar 2021
- First submitted
- 21 Feb 2021
- Last updated
- 8 Jul 2021
- 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 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Pharmacokinetics and Safety of IBI362 Lyophilized Powder and IBI362 Liquid Formulation in Healthy Chinese Male Subjects
- ClinicalTrials.gov ID
- NCT04773977
- Acronym / sponsor ID
- CIBI362B102
- Conditions
- Overweight/Obesity
- Keywords
- Pharmacokinetic, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 9 Mar 2021 (actual)
- Study completion
- 17 Jun 2021 (actual)
- First posted
- 26 Feb 2021 (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 is a study to evaluate the pharmacokinetic characteristics and safety of IBI362 lyophilized powder and IBI362 liquid formulation in healthy Chinese male subjects.
Detailed description
Pharmacokinetic；Safety
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBI362 liquid formulation | Experimental | Drug: IBI362 liquid formulationParticipants received single subcutaneous injection of IBI362 liquid formulation |
| IBI362 lyophilized powder | Experimental | Drug: IBI362 lyophilized powderParticipants received single subcutaneous injection of IBI362 lyophilized powder |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 20 years old≤ Healthy males≤45 years old
- 19 kilograms per meter squared (kg/m²)≤Body Mass Index≤26 kg/m²
- Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff
Key exclusion criteria (6 listed)
- Subjects who have previously completed or discontinued from this study, or who have used IBI362.
- Abnormal vital signs and physical examination during the screening period;
- Having cardiovascular, respiratory, liver, kidney, digestive, endocrine, hematologic, neurological, or muscle degenerative diseases can significantly affect drug absorption, metabolism, or elimination, or participation in the study increases risk or interferes with data interpretation.
- Have a previous or current mental illness.
- A family history of medullary thyroid carcinoma or multiple endocrine tumor syndrome type 2.
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 |
|---|---|---|
| IBI362 liquid formulationAdministered by subcutaneous injection | Drug | IBI362 liquid formulation |
| IBI362 lyophilized powderAdministered by subcutaneous injection | Drug | IBI362 lyophilized powder |
Primary outcome
Evaluate the PK parameters of IBI362 in healthy Chinese male subjects
Time frame: From the first dose of study drug until 8 weeks
Peak Plasma Concentration (Cmax)
Evaluate the PK parameters of IBI362 in healthy Chinese male subjects
Time frame: From the first dose of study drug until 8 weeks
Area under the plasma concentration versus time curve (AUC)
1 secondary outcome
Number of Participants With Adverse Events
Time frame: From the first dose of study drug until 8 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 8 Jul 2021.
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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.
Jian Li principal investigator
The Sceond Affiliated Hospital of Nanchang 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 IBI362 liquid formulation and IBI362 lyophilized powder in people with Overweight/Obesity, 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 6 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 8 Jul 2021. 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?
Evaluate the PK parameters of IBI362 in healthy Chinese male subjects (time frame: From the first dose of study drug until 8 weeks). The study lists 2 primary outcomes in all. 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 8 Jul 2021.