UC - Ulcerative ColitisPhase 1NCT07505030
To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of LYNC-101 for Injection in Healthy Adult Participants
A Phase 1 study testing LYNC-101 in people with UC - Ulcerative Colitis, run by LyncBio Therapeutics Co., Ltd. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 daysHealthy volunteers can take part
- Conditions the study is for
- UC - Ulcerative Colitis
- What is being tested?
- LYNC-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteAustralia
- Study dates
- 28 May 2026to 11 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
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- 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.
- Participants who have experienced blood loss or blood donation exceeding 400 mL within 3 months prior to screening.
- Participants with no ability to tolerate venipuncture, or with history of difficult blood collection, history of vasovagal syncope related to blood draws, or poor venous access.
- Participants who smoke > 5 cigarettes per day (or equivalent use of other nicotine-containing products) within 6 months prior to screening, or are unable to refrain from tobacco use during the study.
- Participants who have an alcohol consumption exceeding 14 units per week (1 unit = 285 mL beer, 25 mL spirits, or 100 mL wine) within 3 months prior to screening, or are unable to abstain from alcohol at least 24 hours before each Study Site admission and each outpatient visit and throughout the duration of each Study Site visit, or have a positive alcohol breath test at screening or Day -1, and a repeat test is allowed if required.
- Participants with a history of drug abuse or positive urine drug screening or Day -1, and a repeat test is allowed if required.
- Participants who are unable to refrain from consuming xanthine-rich beverages (e.g., chocolate, coffee, tea), foods (e.g., animal liver), or fruits/juices known to affect drug metabolism (e.g., grapefruit, pomelo, star fruit) from 3 days before dosing through the confinement period; or are unable to avoid strenuous exercise from 48 hours before dosing through the confinement period; or have any other behavior that could significantly affect drug absorption, distribution, metabolism, or excretion.
- Female participants who are pregnant, breastfeeding.
- Female participants of childbearing potential with positive pregnancy test at screening or Day -1.
- Participants with any other condition that, as assessed by the Investigator, would pose a safety risk to the participant, interfere with the study conduct, or compromise the participant's ability to complete the study or comply with relevant requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, 5000
About this study
Official title: A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of LYNC-101 for Injection in Healthy Adult Participants
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.
Read the detailed description
Part 1: Single Ascending Dose (SAD) Part 1 is designed to evaluate the safety, tolerability, PK, PD, immunogenicity, and cytokine profiles of a single intravenous dose of LYNC-101 for Injection in healthy adult participants.
Eligible participants will be sequentially enrolled into 5 ascending dose groups: 1 mg/kg, 2.5 mg/kg, 4 mg/kg, 6 mg/kg, and 8 mg/kg. Group 1 will enroll 2 participants randomized to receive LYNC-101 for Injection or placebo. Groups 2 through 5 will each enroll 8 participants, randomized so that 6 participants receive LYNC-101 for Injection and 2 participants receive placebo.
Participants will be admitted to the Phase I clinical study site on Day -1 and will receive a single intravenous infusion of LYNC-101 for Injection or placebo on Day 1. Participants will remain at the study site through Day 5 and may be discharged after completion of safety and blood sampling assessments, with investigator approval. Participants will return for follow-up assessments and blood sampling on Days 8, 11, 15, 22, 29, 36, and 43 after dosing.
Sentinel dosing will be implemented in all dose groups except Group 1. In each applicable cohort, the first 2 participants will be randomized in a 1:1 ratio to receive LYNC-101 for Injection or placebo. If no significant safety concerns are identified within 72 hours after dosing in the sentinel participants, the remaining participants in the cohort will be randomized in a ratio of 5:1 to receive LYNC-101 for Injection or placebo.
Dose escalation will proceed stepwise from the lowest dose level. The Safety Review Committee (SRC) will review safety, tolerability, and available PK data through Day 15 after dosing of the last participant in each cohort to determine whether escalation to the next dose level may proceed.
Part 2: Multiple Ascending Dose (MAD) Part 2 is designed to evaluate the safety, tolerability, PK, PD, immunogenicity, and cytokine profiles of multiple intravenous doses of LYNC-101 for Injection in healthy adult participants.
Eligible participants will be sequentially enrolled into 2 ascending dose groups, tentatively planned as 3 mg/kg and 4 mg/kg, with dose levels subject to adjustment based on results from the SAD part. Approximately 16 participants are planned in total. Each cohort will include 8 participants randomized in a 3:1 ratio to receive LYNC-101 for Injection or placebo, such that 6 participants receive LYNC-101 for Injection and 2 participants receive placebo.
Participants will receive study treatment once every 21 days for a total of 3 doses on Days 1, 22, and 43. Participants will be admitted on Day -1 before each dosing period and discharged after completion of post-dose safety and blood sampling assessments, with investigator approval.
The SRC will review safety, tolerability, and available PK data through Day 57 after the last dose of the last participant in each cohort to determine whether escalation to the next dose level may proceed.
Based on accumulated safety, tolerability, and PK data, the Investigator and Sponsor may modify the study design, including dose levels, post-dose observation periods, timing of safety assessments, and PK/PD/immunogenicity/cytokine sampling schedules.
- Conditions
- UC - Ulcerative Colitis
- Being tested
- LYNC-101, LYNC-101 Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LYNC-101Drug
Also called LYNC-101 for injection
SAD:Administered as a single dose via intravenous infusion. MAD:Administered via intravenous infusion every 3 weeks.
LYNC-101 PlaceboDrug
Also called Placebo LYNC-101 for injection
LYNC-101 Placebo SAD:Administered as a single dose via intravenous infusion. MAD:Administered via intravenous infusion every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| SAD:dose 1 | Experimental | 1 receiving LYNC-101 for Injection and 1 receiving placebo Receives: Drug: LYNC-101; Drug: LYNC-101 Placebo |
| SAD:dose2 | Experimental | 6 to receive LYNC-101 for Injection and 2 to receive placebo Receives: Drug: LYNC-101; Drug: LYNC-101 Placebo |
| SAD:dose3 | Experimental | 6 to receive LYNC-101 for Injection and 2 to receive placebo Receives: Drug: LYNC-101; Drug: LYNC-101 Placebo |
| SAD:dose4 | Experimental | 6 to receive LYNC-101 for Injection and 2 to receive placebo Receives: Drug: LYNC-101; Drug: LYNC-101 Placebo |
| SAD:dose5 | Experimental | 6 to receive LYNC-101 for Injection and 2 to receive placebo Receives: Drug: LYNC-101; Drug: LYNC-101 Placebo |
| MAD:dose1 | Experimental | 6 to receive LYNC-101 for Injection and 2 to receive placebo Receives: Drug: LYNC-101; Drug: LYNC-101 Placebo |
| MAD:dose2 | Experimental | 6 to receive LYNC-101 for Injection and 2 to receive placebo Receives: Drug: LYNC-101; Drug: LYNC-101 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: SAD groups: up to 43 days; MAD groups: up to 85 days
Secondary outcomes (15)
Maximum observed plasma concentration (Cmax) of LYNC-101
Measured: SAD groups: up to 43 days; MAD groups: up to 85 days
Time to maximum observed plasma concentration (Tmax) of LYNC-101
Measured: 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)
Measured: 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)
Measured: 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)
Measured: SAD groups: up to 43 days; MAD groups: up to 85 days
Apparent volume of distribution (Vz)
Measured: SAD groups: up to 43 days; MAD groups: up to 85 days
Plasma clearance (CL)
Measured: SAD groups: up to 43 days; MAD groups: up to 85 days
Plasma elimination half-life (t1/2)
Measured: SAD groups: up to 43 days; MAD groups: up to 85 days
Time to maximum concentration at steady state (Tmax,ss)
Measured: MAD groups only: up to 85 days
Maximum concentration at steady state (Cmax,ss)
Measured: MAD groups only: up to 85 days
Trough concentration at steady state (Cmin,ss)
Measured: MAD groups only: up to 85 days
Mean concentration at steady state (Cav,ss)
Measured: MAD groups only: up to 85 days
Area under the steady-state plasma concentration-time curve (AUCss)
Measured: MAD groups only: up to 85 days
Accumulation ratio (Rac)
Measured: MAD groups only: up to 85 days
Incidence and characteristics of anti-drug antibodies (ADAs)
Measured: SAD groups: up to 43 days; MAD groups: up to 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start28 May 2026
- Primary completion19 Mar 2027 (estimated)
- Study completion11 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UC - Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LyncBio Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cexiong Fu, Study chair, LyncBio Therapeutics Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505030
- Sponsor's protocol ID
- LYNC-101-I-01
- Status last verified
- Aug 2026
- First submitted
- 22 Mar 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of LYNC-101 for Injection in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07505030
- Acronym / sponsor ID
- LYNC-101-I-01
- Conditions
- UC - Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- LyncBio Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 May 2026 (actual)
- Primary completion
- 19 Mar 2027 (estimated)
- Study completion
- 11 Apr 2027 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Part 1: Single Ascending Dose (SAD) Part 1 is designed to evaluate the safety, tolerability, PK, PD, immunogenicity, and cytokine profiles of a single intravenous dose of LYNC-101 for Injection in healthy adult participants.
Eligible participants will be sequentially enrolled into 5 ascending dose groups: 1 mg/kg, 2.5 mg/kg, 4 mg/kg, 6 mg/kg, and 8 mg/kg. Group 1 will enroll 2 participants randomized to receive LYNC-101 for Injection or placebo. Groups 2 through 5 will each enroll 8 participants, randomized so that 6 participants receive LYNC-101 for Injection and 2 participants receive placebo.
Participants will be admitted to the Phase I clinical study site on Day -1 and will receive a single intravenous infusion of LYNC-101 for Injection or placebo on Day 1. Participants will remain at the study site through Day 5 and may be discharged after completion of safety and blood sampling assessments, with investigator approval. Participants will return for follow-up assessments and blood sampling on Days 8, 11, 15, 22, 29, 36, and 43 after dosing.
Sentinel dosing will be implemented in all dose groups except Group 1. In each applicable cohort, the first 2 participants will be randomized in a 1:1 ratio to receive LYNC-101 for Injection or placebo. If no significant safety concerns are identified within 72 hours after dosing in the sentinel participants, the remaining participants in the cohort will be randomized in a ratio of 5:1 to receive LYNC-101 for Injection or placebo.
Dose escalation will proceed stepwise from the lowest dose level. The Safety Review Committee (SRC) will review safety, tolerability, and available PK data through Day 15 after dosing of the last participant in each cohort to determine whether escalation to the next dose level may proceed.
Part 2: Multiple Ascending Dose (MAD) Part 2 is designed to evaluate the safety, tolerability, PK, PD, immunogenicity, and cytokine profiles of multiple intravenous doses of LYNC-101 for Injection in healthy adult participants.
Eligible participants will be sequentially enrolled into 2 ascending dose groups, tentatively planned as 3 mg/kg and 4 mg/kg, with dose levels subject to adjustment based on results from the SAD part. Approximately 16 participants are planned in total. Each cohort will include 8 participants randomized in a 3:1 ratio to receive LYNC-101 for Injection or placebo, such that 6 participants receive LYNC-101 for Injection and 2 participants receive placebo.
Participants will receive study treatment once every 21 days for a total of 3 doses on Days 1, 22, and 43. Participants will be admitted on Day -1 before each dosing period and discharged after completion of post-dose safety and blood sampling assessments, with investigator approval.
The SRC will review safety, tolerability, and available PK data through Day 57 after the last dose of the last participant in each cohort to determine whether escalation to the next dose level may proceed.
Based on accumulated safety, tolerability, and PK data, the Investigator and Sponsor may modify the study design, including dose levels, post-dose observation periods, timing of safety assessments, and PK/PD/immunogenicity/cytokine sampling schedules.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| SAD:dose 1 | Experimental | Drug: LYNC-101, Drug: LYNC-101 Placebo1 receiving LYNC-101 for Injection and 1 receiving placebo |
| SAD:dose2 | Experimental | Drug: LYNC-101, Drug: LYNC-101 Placebo6 to receive LYNC-101 for Injection and 2 to receive placebo |
| SAD:dose3 | Experimental | Drug: LYNC-101, Drug: LYNC-101 Placebo6 to receive LYNC-101 for Injection and 2 to receive placebo |
| SAD:dose4 | Experimental | Drug: LYNC-101, Drug: LYNC-101 Placebo6 to receive LYNC-101 for Injection and 2 to receive placebo |
| SAD:dose5 | Experimental | Drug: LYNC-101, Drug: LYNC-101 Placebo6 to receive LYNC-101 for Injection and 2 to receive placebo |
| MAD:dose1 | Experimental | Drug: LYNC-101, Drug: LYNC-101 Placebo6 to receive LYNC-101 for Injection and 2 to receive placebo |
| MAD:dose2 | Experimental | Drug: LYNC-101, Drug: LYNC-101 Placebo6 to receive LYNC-101 for Injection and 2 to receive placebo |
Who may qualify
- Ages
- 18 to 60 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LYNC-101Also: LYNC-101 for injectionSAD:Administered as a single dose via intravenous infusion. MAD:Administered via intravenous infusion every 3 weeks. | Drug | MAD:dose1, MAD:dose2, SAD:dose 1, SAD:dose2, SAD:dose3, SAD:dose4, SAD:dose5 |
| LYNC-101 PlaceboAlso: Placebo LYNC-101 for injectionLYNC-101 Placebo SAD:Administered as a single dose via intravenous infusion. MAD:Administered via intravenous infusion every 3 weeks. | Drug | MAD:dose1, MAD:dose2, SAD:dose 1, SAD:dose2, SAD:dose3, SAD:dose4, SAD:dose5 |
Primary outcome
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs)
Time frame: SAD groups: up to 43 days; MAD groups: up to 85 days
Changes in 12-lead electrocardiogram parameters (ECG QT Interval, etc)
Time frame: SAD groups: up to 43 days; MAD groups: up to 85 days
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.
Changes in vital signs (Number of participants with treatment-related adverse events as assessed by CTCAE v6.0)
Time frame: SAD groups: up to 43 days; MAD groups: up to 85 days
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.
Changes in physical examination findings (Number of participants with treatment-related adverse events as assessed by CTCAE v6.0)
Time frame: SAD groups: up to 43 days; MAD groups: up to 85 days
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.
Changes in clinical laboratory test results(Number of participants with treatment-related adverse events as assessed by CTCAE v6.0)
Time frame: SAD groups: up to 43 days; MAD groups: up to 85 days
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.
15 secondary outcomes
Maximum observed plasma concentration (Cmax) of LYNC-101
Time frame: SAD groups: up to 43 days; MAD groups: up to 85 days
Time to maximum observed plasma concentration (Tmax) of LYNC-101
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: SAD groups: up to 43 days; MAD groups: up to 85 days
Apparent volume of distribution (Vz)
Time frame: SAD groups: up to 43 days; MAD groups: up to 85 days
Plasma clearance (CL)
Time frame: SAD groups: up to 43 days; MAD groups: up to 85 days
Plasma elimination half-life (t1/2)
Time frame: SAD groups: up to 43 days; MAD groups: up to 85 days
Time to maximum concentration at steady state (Tmax,ss)
Time frame: MAD groups only: up to 85 days
Maximum concentration at steady state (Cmax,ss)
Time frame: MAD groups only: up to 85 days
Trough concentration at steady state (Cmin,ss)
Time frame: MAD groups only: up to 85 days
Mean concentration at steady state (Cav,ss)
Time frame: MAD groups only: up to 85 days
Area under the steady-state plasma concentration-time curve (AUCss)
Time frame: MAD groups only: up to 85 days
Accumulation ratio (Rac)
Time frame: MAD groups only: up to 85 days
Incidence and characteristics of anti-drug antibodies (ADAs)
Time frame: SAD groups: up to 43 days; MAD groups: up to 85 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Active, not recruitingPhase 3
An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
Ulcerative Colitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cexiong Fu study chair
LyncBio Therapeutics Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LYNC-101 in people with UC - Ulcerative Colitis, run by LyncBio Therapeutics Co., Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs) (time frame: SAD groups: up to 43 days; MAD groups: up to 85 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.