A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HY6725 Following Single and Multiple Subcutaneous Doses in Healthy Participants
Overview
- Phase
- Phase 1
- Intervention
- HY6725
- Conditions
- Not specified
- Sponsor
- Newsoara Biopharma Co., Ltd.
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Safety data including incidence and severity of TEAEs, SAEs, change from baseline in vital signs, lab values and ECG parameters.
- 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 HY6725 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 HY6725 in healthy adult participants?
- What is the PK character of HY6725 following administration of single and multiple doses of HY6725 in healthy adult participants?
Researchers will compare HY6725 to a placebo (a look-alike substance that contains no drug) to see if HY6725 is safe and well tolerated.
Participants will take HY6725 or a placebo once or twice in single dose group or multiple dose group. And will be follow-up until Day 150.
Detailed Description
The rationale of the study is HY6725 is a novel, fully human monoclonal antibody engineered to simultaneously neutralize human TSLP and IL-33. Given the overlapping, synergistic, and compensatory roles of TSLP and IL-33 in the pathogenesis of asthma and COPD-as well as in other chronic type 2 inflammatory diseases-simultaneous inhibition offers a promising therapeutic strategy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female participants must be 18 to 55 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, vital sign assessments, laboratory tests, and 12-lead ECGs.
- •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 (but excluding resolved childhood asthma), gastrointestinal (but excluding resolved gall bladder and appendix removal), cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- •History of HIV infection, hepatitis B, hepatitis C or syphilis; positive testing for HIV, hepatitis B, HCVAb or serological reaction of syphilis
- •For hepatitis B, all participants must undergo testing for HBsAg, HBcAb, and HBsAb.
- •Participants who are negative for all 3 serology tests may be eligible.
- •Participants who are HBsAg positive will be excluded.
- •HBsAg negative, HBcAb positive, and HBsAb negative particpants are to be excluded from the study.
- •Participants who are HBsAg negative, HBcAb negative and HBsAb positive and provide documentation of prior HBV vaccination, may be eligible for the study and will not require HBV DNA monitoring during the study.
- •Participants who are HBsAg negative, HBcAb negative and HBsAb positive without documentation of prior HBV vaccination AND participants who are HBsAg negative, HBcAb positive, and HBsAb positive, will have HBV DNA assessed at screening.
- •If HBV DNA is detectable, participants will be excluded.
- •If HBV DNA is not detectable, participants may be eligible.
Arms & Interventions
HY6725
It's an injection solution. SAD part for subcutaneous dosing in 7 cohorts, including 3mg, 10mg, 30mg, 90mg, 150mg, 300mg and 450mg with only one administration on Day 1 of each cohort. MAD part for subcutaneous dosing in 3 cohorts, including 150mg, 300mg and 450mg with two administrations on Day 1 and Day 30 of each cohort.
Intervention: HY6725
placebo
It's same injection solution just without active ingredient compared with HY6725. SAD part for subcutaneous dosing in 7 cohorts, including 3mg, 10mg, 30mg, 90mg, 150mg, 300mg and 450mg with only one administration on Day 1 of each cohort. MAD part for subcutaneous dosing in 3 cohorts, including 150mg, 300mg and 450mg with two administrations on Day 1 and Day 30 of each cohort.
Intervention: Placebo Control
Outcomes
Primary Outcomes
Safety data including incidence and severity of TEAEs, SAEs, change from baseline in vital signs, lab values and ECG parameters.
Time Frame: From signing informed consent form to the end of study at Day 150.
Secondary Outcomes
- Peak Plasma Concentration (Cmax)(From Day1 predose to Day 150.)
- Area under the plasma concentration versus time curve (AUC)(From Day1 predose to Day 150.)
- Time to maximum concentration (Tmax)(From Day1 predose to Day 150.)
- Plasma half-life time (T1/2)(From Day1 predose to Day 150.)