Evaluation of the Safety, Tolerability and Pharmacokinetics of HY6725 in Healthy Adult Participants

NCT07262281 | Recruiting Phase 1

• 1 other identifier: HY6725-01-01
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Safety data including incidence and severity of TEAEs, SAEs, change from baseline in vital signs, lab values and ECG parameters.

  From signing informed consent form to the end of study at Day 150.

Secondary Outcomes (4)

• 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.

Study Arms (2)

HY6725

EXPERIMENTAL

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.

Biological: HY6725

placebo

PLACEBO COMPARATOR

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.

Other: Placebo Control

Interventions

HY6725 BIOLOGICAL

HY6725 is an injection solution with 120mg/ml per vial. 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.

HY6725

Placebo Control OTHER

A vial with 1ml injection solution contain same ingredient except HY6725 compared with HY6725 solution.

placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• History of severe allergic or anaphylactic reaction to a therapeutic drug.
• History of recent active infections within 28 days prior to the screening visit.
• History of recent iron deficiency requiring treatment within 3 months before the first dose of study intervention.
• Participants with a fever within 48 hours prior to dosing.
• Participants who are QFT-G test positive will be excluded.

Sponsors & Collaborators

• Newsoara Biopharma Co., Ltd.: lead

Study Sites (1)

Nucleus Network Pty Ltd.

Melbourne, Australia

RECRUITING

Study Officials

• Weifen Zhou, Dr.

  Newsoara Biopharma Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Vandy Xu

CONTACT

+8613651674576; vandy.xu@newsoara.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 3, 2025
• Study Start: February 6, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 11, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)