IBI3032 for Healthy Subjects

Overseen By lily Zhang

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Fortvita Biologics (USA)Inc.

Disqualifiers: Cardiovascular, Respiratory, Hepatic, others

Compensation: Varies

Number of Visits: 16

Duration: 1 day

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety, tolerability, and processing of a new treatment called IBI3032. In its early stages (Phase 1), it involves healthy participants who will receive either the treatment or a placebo (a harmless pill that resembles the treatment but has no effect). The trial aims to determine how a single dose of IBI3032 affects healthy individuals. Ideal candidates are healthy people without allergies to similar compounds and with normal lab results. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the unique opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, since the study is for healthy participants, it's likely that you should not be on any regular medications. Please check with the trial coordinators for specific guidance.

Is there any evidence suggesting that IBI3032 is likely to be safe for humans?

Research has shown that IBI3032 was well-tolerated in earlier studies. In animal tests, it was absorbed well when taken orally and worked effectively without causing harm at similar doses. This suggests that IBI3032 might be safe for humans, but it is important to remember that this trial remains in its early stages. The current study aims to gather more information about how people handle IBI3032. It is designed to carefully monitor any possible side effects in healthy participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Unlike current treatments, IBI3032 is being explored for its unique delivery method and potential benefits for healthy subjects. Researchers are particularly excited about IBI3032 because it is administered orally, which can enhance ease of use and compliance compared to more invasive methods. Additionally, IBI3032 may operate with a novel mechanism of action, offering a fresh approach that could lead to innovative applications beyond existing options. This distinct profile has piqued interest as it could pave the way for new therapeutic strategies.

What evidence suggests that IBI3032 could be effective?

Research has shown that IBI3032 produced promising results in animal studies. In these studies, oral absorption of IBI3032 was 5 to 10 times higher than similar treatments. This increased absorption improved its effectiveness in the animal tests. The treatment was also well-tolerated, causing no major side effects. Although these results come from animal studies, they suggest that IBI3032 could be effective in future human trials. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

This clinical trial is for approximately 32 healthy individuals who are willing to participate in a study evaluating the safety of a new drug called IBI3032. Participants will be divided into groups and randomly assigned to receive either IBI3032 or a placebo.

Inclusion Criteria

Participants must have safety laboratory results within normal reference ranges

I am healthy based on my medical history.

Exclusion Criteria

Abnormal electrocardiogram (ECG) at screening

I have no major ongoing issues with my heart, lungs, liver, kidneys, stomach, hormones, blood, or nervous system.

I am not allergic to IBI3032, GLP-1 analogs, or similar drugs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive a single ascending dose of IBI3032 or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 days

Follow-up assessments conducted up to Day 15

What Are the Treatments Tested in This Trial?

Interventions

• IBI3032

Trial Overview The trial is testing the safety, tolerability, and pharmacokinetics (how the drug moves through the body) of a single dose of IBI3032 compared to a placebo. It's structured as a double-blind study where neither participants nor researchers know who receives the actual drug or placebo.

How Is the Trial Designed?

Group I: Single dose4 of IBI3032 administered orally. Experimental Treatment 1 Intervention

dose4 IBI3032

Group II: Single dose3 of IBI3032 administered orally. Experimental Treatment 1 Intervention

dose3 IBI3032

Group III: Single dose2 of IBI3032 administered orally. Experimental Treatment 1 Intervention

dose2 IBI3032

Group IV: Single dose1 of IBI3032 administered orally. Experimental Treatment 1 Intervention

dose1 IBI3032

Group V: Single dose4 of placebo administered orally. Placebo Group 1 Intervention

dose4 placebo

Group VI: Single dose3 of placebo administered orally. Placebo Group 1 Intervention

dose3 placebo

Group VII: Single dose1 of placebo administered orally. Placebo Group 1 Intervention

dose1 placebo

Group VIII: Single dose2 of placebo administered orally. Placebo Group 1 Intervention

dose2 placebo

Who Is Running the Clinical Trial?

Fortvita Biologics (USA)Inc.

Lead Sponsor

Trials

1

Recruited

80+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07170319

A Study of IBI3032 in Chinese Participants With Overweight ... To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants. Day 1 and Day 28：Predose up to 24 ...

2. biospace.com biospace.com/press-releases/innovent-receives-u-s-fda-approval-for-ind-application-of-oral-glp-1r-agonist-ibi3032

Innovent Receives U.S. FDA Approval for IND Application ... In animal models, IBI3032 achieved 5 to 10 times higher oral exposure at equivalent doses, with improved efficacy and good tolerability in both ...

3. prnewswire.com prnewswire.com/news-releases/innovent-receives-us-fda-approval-for-ind-application-of-oral-glp-1r-agonist-ibi3032-302520701.html

Innovent Receives U.S. FDA Approval for IND Application ... In animal models, IBI3032 achieved 5 to 10 times higher oral exposure at equivalent doses, with improved efficacy and good tolerability in both ...

4. stocktitan.net stocktitan.net/news/IVBIY/innovent-receives-u-s-fda-approval-for-ind-application-of-oral-glp-7d5znsvtemav.html

FDA Approves Oral GLP-1 Weight Loss Drug IND ... IBI3032 demonstrated superior preclinical results, achieving 5-10 times higher oral exposure at equivalent doses compared to peer compounds. ...

5. ichgcp.net ichgcp.net/clinical-trials-registry/549744-a-study-of-ibi3032-in-chinese-healthy-subjects

Safety Study of IBI3032 in Healthy Volunteers: Understanding How a ... This clinical research study is evaluating a new investigational medication called IBI3032 in healthy adult volunteers. The primary goal is to understand ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07120425

NCT07120425 | A Study of IBI3032 in Healthy Participants To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07134127

A Study of IBI3032 in Chinese Healthy Subjects This is a randomized, double-blind, placebo-controlled Phase I clinical study evaluating the safety, tolerability, PK and food effect of a single dose of ...

8. synapse.patsnap.com synapse.patsnap.com/drug/4b2e0e28d26245c08ca04f6512851910

IBI-3032 - Drug Targets, Indications, Patents Phase 1. A Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IBI3032 in Healthy Participants.