A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HY8931 Following Single Intravenous and Multiple Subcutaneous Doses in Healthy Participants
Overview
- Phase
- Phase 1
- Intervention
- HY8931
- Conditions
- Not specified
- Sponsor
- Newsoara Biopharma Co., Ltd.
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
- Status
- Recruiting
- Last Updated
- last month
Overview
Brief Summary
The goal of this clinical trial is to learn the safety, tolerability and pharmacokinetics of single and multiple doses of HY8931 in healthy adult participants. The main questions it aims to answer are:
- How is the safety and tolerability following administration of single and multiple doses of HY8931 in healthy adult participants?
- What is the PK character of HY8931 following administration of single and multiple doses of HY8931 in healthy adult participants?
Researchers will compare HY8931 to a placebo (a look-alike substance that contains no drug) to see if HY8931 is safe and well tolerated.
Participants will take HY8931 or a placebo once or twice in single dose group or multiple dose group. And will be follow-up until Day 90.
Detailed Description
The rationale of the study is by simultaneously targeting TL1A and IL-23p19, HY8931 as an investigational bispecific antibody, presents a novel and promising therapeutic strategy. It has the potential to disrupt multiple pathogenic pathways in IBD, effectively breaking the vicious cycle of inflammation. Pre-clinical studies have demonstrated that the dual inhibition of these cytokines can effectively reduce eosinophilic inflammation, airway hyperresponsiveness, and tissue remodeling in animal models. This approach holds the potential to not only alleviate acute symptoms but also modify the disease course, offering a more comprehensive and effective treatment strategy for patients suffering from these debilitating respiratory conditions.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female participants must be 18 to 45 years of age, inclusive, at the time of signing the informed consent.
- •Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital sign and 12-lead ECG.
- •Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- •BMI of 18 to 32 kg/m2; and a total body weight \>50 kg.
- •Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent and in this protocol.
Exclusion Criteria
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- •Positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody or positive testing for HIV or syphilis at the screening visit.
- •History of allergic or anaphylactic reaction to a therapeutic drug.
- •History of recent active infections within 28 days prior to the screening visit.
- •Participants with a fever within 48 hours prior to dosing.
- •Positive QFT-G test.
- •History of recurrent bacterial infection (\>3 per year) or recurrent HSV infection.
- •The medications as listed in section 6.9.2 are exclusionary, all other medications and supplements allowed at investigator discretion. (Refer to Section 6.9 Prior and Concomitant Therapy for additional details).
- •Recent exposure to live vaccines within 28 days of the screening visit or plan to receive live vaccination during the trial.
- •Known exposure to anti-TL1A or IL23 or any type of anti-TL1A or anti-IL23 therapy.
Arms & Interventions
HY8931
It's an injection solution. SAD part for intravenous dosing in 6 cohorts, including 10mg, 30mg, 60mg, 120mg, 240mg and 360mg with only one administration on Day 1 of each cohort. SAD part for subcutaneous dosing in 120mg cohort with only one administration on Day 1; MAD part for subcutaneous dosing in 3 cohorts, including 120mg, 240mg, 360mg with two administrations on Day 1 and Day 30 of each cohort.
Intervention: HY8931
placebo
It's same injection solution just without active ingredient compared with HY8931. SAD part for intravenous dosing in 6 cohorts, including 10mg, 30mg, 60mg, 120mg, 240mg and 360mg with only one administration on Day 1 of each cohort. SAD part for subcutaneous dosing in 120mg cohort with only one administration on Day 1; MAD part for subcutaneous dosing in 3 cohorts, including 120mg, 240mg, 360mg with two administrations on Day 1 and Day 30 of each cohort.
Intervention: Placebo Control
Outcomes
Primary Outcomes
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time Frame: From signing informed consent form to the end of study at Day 90.
Secondary Outcomes
- Peak Plasma Concentration (Cmax)(From Day1 predose to Day 90.)
- Area under the plasma concentration versus time curve (AUC)(From Day1 predose to Day 90.)
- Time to maximum concentration (Tmax)(From Day1 predose to Day 90.)
- Plasma half-life time (T1/2)(From Day1 predose to Day 90.)