To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of L… (NCT07505030) | Clinical Trial Compass
Not Yet RecruitingPhase 1
To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of LYNC-101 for Injection in Healthy Adult Participants
Australia50 participantsStarted 2026-05-25
Plain-language summary
This Phase I study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and cytokine profiles of LYNC-101 for Injection in healthy adult participants. The study consists of 2 parts: Part 1 is a single ascending dose (SAD) study and Part 2 is a multiple ascending dose (MAD) study. In Part 1, participants will receive a single intravenous infusion of LYNC-101 for Injection or placebo across sequential ascending dose cohorts. In Part 2, participants will receive intravenous infusions of LYNC-101 for Injection or placebo once every 3 weeks for a total of 3 doses across sequential ascending dose cohorts.
Who can participate
Age range18 Days – 60 Days
SexALL
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Inclusion criteria
✓. Healthy male or female participants aged 18-60 years (inclusive).
✓. Body weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI) of 18-32 kg/m² (inclusive).
✓. Able to fully understand the study, voluntarily agree to participate in the study, and sign the informed consent form.
✓. Participants agree to have no plans for conception, sperm donation, or egg donation from the date of signing the informed consent form until 3 months after the last dose and must use effective non-pharmacological contraception with partners of childbearing potential.
Exclusion criteria
✕. Participants with clinically significant abnormalities (as judged by the PI or delegate) in vital signs, physical examinations, laboratory tests, or 12-lead ECG during the screening period.
✕. Participants with positive test result for any of the following: hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or treponema pallidum-specific antibody (TP-Ab).
✕. Participants with history or current presence of any clinically significant disease or disorder of the circulatory, endocrine, metabolic, urinary, digestive, dermatologic, hematologic, nervous, or psychiatric systems, which, as assessed by the Investigator, precludes safe participation in the study.
What they're measuring
1
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs)
Timeframe: SAD groups: up to 43 days; MAD groups: up to 85 days
2
Changes in 12-lead electrocardiogram parameters (ECG QT Interval, etc)
Timeframe: SAD groups: up to 43 days; MAD groups: up to 85 days
3
Changes in vital signs (Number of participants with treatment-related adverse events as assessed by CTCAE v6.0)
Timeframe: SAD groups: up to 43 days; MAD groups: up to 85 days
4
Changes in physical examination findings (Number of participants with treatment-related adverse events as assessed by CTCAE v6.0)
Timeframe: SAD groups: up to 43 days; MAD groups: up to 85 days
5
Changes in clinical laboratory test results(Number of participants with treatment-related adverse events as assessed by CTCAE v6.0)
Timeframe: SAD groups: up to 43 days; MAD groups: up to 85 days
✕. History of childhood asthma (regardless of resolution), depression, migraine, or Gilbert's Syndrome. Note: Participants with a history of cholecystectomy are eligible for inclusion.
✕. Participants with history of clinically significant infection (including upper or lower respiratory tract infection) requiring antibiotic or antiviral treatment within 14 days prior to or during screening, in the opinion of the PI or delegate.
✕. Participants who have received major surgery within 4 weeks prior to screening or will receive planned surgery during the study period.
✕. Alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) \>1.5 × upper limit of normal (ULN) at Screening or Day -1. Repeat testing at Screening and Day -1 is acceptable for out-of-range values following approval by the PI or delegate.
✕. Participants with estimated glomerular filtration rate (eGFR) \< 90 mL/min/1.73m2(using Cockroft \& Gault formula). And a repeat sample is allowed if required.