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LYNC-101

Phase 1

UC - Ulcerative Colitis | Small molecule | Immunology |cbdMD, Inc.|Last Updated: Aug 27, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

LYNC-101 · 1 trial · 1 indication

Phase 1 1
NCT07505030To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of LYNC-101 for Injection in Healthy Adult ParticipantsUC - Ulcerative Colitis
ENROLLING BY_INVITATION50 Analytics
PHASE1ENROLLING BY_INVITATION
To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of LYNC-101 for Injection in Healthy Adult Participants
UC - Ulcerative ColitisUnlock trial analytics

Study Endpoints

Primary Endpoints

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)
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)
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)
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)
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.

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SAD:dose 1EXPERIMENTAL1 receiving LYNC-101 for Injection and 1 receiving placebo
SAD:dose2EXPERIMENTAL6 to receive LYNC-101 for Injection and 2 to receive placebo
SAD:dose3EXPERIMENTAL6 to receive LYNC-101 for Injection and 2 to receive placebo
SAD:dose4EXPERIMENTAL6 to receive LYNC-101 for Injection and 2 to receive placebo
SAD:dose5EXPERIMENTAL6 to receive LYNC-101 for Injection and 2 to receive placebo
MAD:dose1EXPERIMENTAL6 to receive LYNC-101 for Injection and 2 to receive placebo
MAD:dose2EXPERIMENTAL6 to receive LYNC-101 for Injection and 2 to receive placebo

Interventions

NameTypeDescription
LYNC-101DRUGSAD:Administered as a single dose via intravenous infusion. MAD:Administered via intravenous infusion every 3 weeks.
LYNC-101 PlaceboDRUGLYNC-101 Placebo SAD:Administered as a single dose via intravenous infusion. MAD:Administered via intravenous infusion every 3 weeks.
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Eligibility Criteria

Age Range18 Days to 60 Days
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy male or female participants aged 18-60 years (inclusive). 2. Body weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI) of 18-32 kg/m² (inclusive). 3. Able to fully understand the study, voluntarily agree to participate in the study, and sign ...

Countries:Australia
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