To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of LYNC-101 for Injection in Healthy Adult Participants

NCT07505030 | Not Yet Recruiting Phase 1

• 1 other identifier: LYNC-101-I-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

UC - Ulcerative Colitis

Outcome Measures

Primary Outcomes (5)

• Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs)

  SAD groups: up to 43 days; MAD groups: up to 85 days

• Changes in 12-lead electrocardiogram parameters (ECG QT Interval, etc)

  Heart rate (HR), PR interval, QT interval, QRS interval, and QTcF interval should be recorded. During the screening period, if an abnormal corrected QT interval (QTcF) is determined by the Investigator, it may be re-measured up to 2 times, with a recommended interval of at least 5 minutes between each measurement, and the average QTcF value of the three measurements should be calculated. QTcF = QT/(RR\^0.33), RR = 60 / HR. During the study, the Investigator will determine whether a repeat measurement is necessary.

  SAD groups: up to 43 days; MAD groups: up to 85 days

• Changes in vital signs (Number of participants with treatment-related adverse events as assessed by CTCAE v6.0)

  Including sitting blood pressure, respiration, pulse, and body temperature (axillary, tympanic, or forehead temperature are all acceptable, but participants at the same study site must use a consistent method). Vital signs will be measured at the times specified in the study schedule. Additional vital sign tests may be performed during the study if abnormalities are clinically significant.

  SAD groups: up to 43 days; MAD groups: up to 85 days

• Changes in physical examination findings (Number of participants with treatment-related adverse events as assessed by CTCAE v6.0)

  Physical examinations will be conducted according to the study assessment schedule. Comprehensive physical examinations include general condition (including overall appearance, skin, mucous membranes, lymph nodes, etc.), head, neck, chest, abdomen, spine and extremities, and nervous system, and other.

  SAD groups: up to 43 days; MAD groups: up to 85 days

• Changes in clinical laboratory test results(Number of participants with treatment-related adverse events as assessed by CTCAE v6.0)

  Laboratory tests shall be performed according to the study assessment schedule. The Investigator must evaluate all values outside the normal range (CS: clinically significant; NCS: not clinically significant) and sign with their name and date. Only abnormalities judged by the Investigator as CS and meeting the definition of AE shall be recorded as an AE. In this study, the Investigator may, at their own discretion, perform additional or repeated tests if deemed necessary.

  SAD groups: up to 43 days; MAD groups: up to 85 days

Secondary Outcomes (15)

• Maximum observed plasma concentration (Cmax) of LYNC-101

  SAD groups: up to 43 days; MAD groups: up to 85 days

• Time to maximum observed plasma concentration (Tmax) of LYNC-101

  SAD groups: up to 43 days; MAD groups: up to 85 days

• Area under the plasma concentration-time curve from time 0 to 504 hours (AUC0-504h)

  SAD groups: up to 43 days; MAD groups: up to 85 days

• Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t)

  SAD groups: up to 43 days; MAD groups: up to 85 days

• Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)

  SAD groups: up to 43 days; MAD groups: up to 85 days

Study Arms (7)

SAD:dose 1

EXPERIMENTAL

1 receiving LYNC-101 for Injection and 1 receiving placebo

Drug: LYNC-101; Drug: LYNC-101 Placebo

SAD:dose2

EXPERIMENTAL

6 to receive LYNC-101 for Injection and 2 to receive placebo

Drug: LYNC-101; Drug: LYNC-101 Placebo

SAD:dose3

EXPERIMENTAL

6 to receive LYNC-101 for Injection and 2 to receive placebo

Drug: LYNC-101; Drug: LYNC-101 Placebo

SAD:dose4

EXPERIMENTAL

6 to receive LYNC-101 for Injection and 2 to receive placebo

Drug: LYNC-101; Drug: LYNC-101 Placebo

SAD:dose5

EXPERIMENTAL

6 to receive LYNC-101 for Injection and 2 to receive placebo

Drug: LYNC-101; Drug: LYNC-101 Placebo

MAD:dose1

EXPERIMENTAL

6 to receive LYNC-101 for Injection and 2 to receive placebo

Drug: LYNC-101; Drug: LYNC-101 Placebo

MAD:dose2

EXPERIMENTAL

6 to receive LYNC-101 for Injection and 2 to receive placebo

Drug: LYNC-101; Drug: LYNC-101 Placebo

Interventions

LYNC-101 DRUG

SAD:Administered as a single dose via intravenous infusion. MAD:Administered via intravenous infusion every 3 weeks.

Also known as: LYNC-101 for injection

MAD:dose1; MAD:dose2; SAD:dose 1; SAD:dose2; SAD:dose3; SAD:dose4; SAD:dose5

LYNC-101 Placebo DRUG

LYNC-101 Placebo SAD:Administered as a single dose via intravenous infusion. MAD:Administered via intravenous infusion every 3 weeks.

Also known as: Placebo LYNC-101 for injection

MAD:dose1; MAD:dose2; SAD:dose 1; SAD:dose2; SAD:dose3; SAD:dose4; SAD:dose5

Eligibility Criteria

• Age: 18 Days - 60 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Participants with known history of hypersensitivity, allergic constitution, or allergy to any ingredient of the IMP.
• Participants who have participated in other clinical studies and have received the IMP within 30 days or 5 half-lives (whichever is longer) prior to screening.
• Participants who have received treatment with any marketed or investigational biologic agent within 4 months or 5 half-lives (whichever is longer) prior to screening.
• Participants who have received any prescription drugs (excluding contraception), over-the-counter medications (excluding paracetamol), herbal products, or dietary supplements (excluding vitamin products) within 2 weeks or 5 half-lives (whichever is longer) prior to screening.
• Participants who have received or will receive any systemic cytotoxic or immunosuppressive agent within 6 months prior to screening or during the study, or any topical cytotoxic or immunosuppressive agent within 30 days or 5 half-lives (whichever is longer) prior to screening or during the study.
• Participants who have received B-cell or T-cell depleting agents (e.g., rituximab) within 6 months prior to screening.
• Participants who have been vaccinated 4 weeks prior to first dose or plan to be vaccinated during the study.
• Participants who have received immunoglobulins or blood products within 30 days prior to screening.

Sponsors & Collaborators

• LyncBio Therapeutics Co., Ltd.: lead

Study Sites (1)

CMAX Clinical Research Pty Ltd

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Injections

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Cexiong Fu

  LyncBio Therapeutics Co., Ltd.

  STUDY CHAIR

Central Study Contacts

Jiajie Feng

CONTACT

008613671589062; jiajie.feng@lyncbio.com

Study Design

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

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: April 1, 2026
• Study Start (Estimated): May 25, 2026
• Primary Completion (Estimated): March 19, 2027
• Study Completion (Estimated): April 11, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)