Phase I Clinical Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of … (NCT07178327) | Clinical Trial Compass
By InvitationPhase 1
Phase I Clinical Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of LYN101
China44 participantsStarted 2025-09-06
Plain-language summary
This is a Phase 1, two-part, first-in-human, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of LYN101 in healthy subjects (part A) and multiple doses in postmenopausal women with low bone mass (part B).
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Fully understand the purpose and requirements of the trial, voluntarily participate in the clinical study, and sign a written informed consent form.
✓. Individuals aged 18 to 65 years (inclusive), regardless of gender;
✓. Weight ≥ 50 kg for males or at least 45 kg for females, with a Body Mass Index (BMI) ranging from 18.0 to 30.0 kg/m² (inclusive).
✓. Males and females of childbearing potential agree not to plan for childbearing and to use reliable contraceptive measures from the time of signing the written informed consent until 6 months after dosing. They also agree not to donate sperm or ova.
✓. Fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial, and sign a written informed consent form.
✓. Individuals aged 50-70 years (inclusive), female, and ambulatory.
✓. Spontaneous amenorrhea lasting for at least two years or bilateral oophorectomy performed at least two years prior. For women under 60 years of age who have undergone hysterectomy but retained their ovaries, or when the status of bilateral oophorectomy is unknown, menopausal status must be confirmed by follicle-stimulating hormone (FSH) levels exceeding 40 mIU/mL or in accordance with the postmenopausal range established by the local laboratory.
✓. During the screening process, at least two consecutive vertebrae within the L1-L4 region must be evaluable for DXA BMD assessment, and at least one hip must also be evaluable for DXA BMD assessment.
Exclusion criteria
✕
What they're measuring
1
Number of participants with adverse events
Timeframe: Up to Day 91 from dosing in part A. Up to 265 from first dosing in part B.
. Systolic blood pressure (SBP) ≥140 mm Hg and/or diastolic blood pressure (DBP) ≥90 mm Hg after at least five minutes of rest during screening assessments.
✕. Clinically significant abnormalities observed in the 12-lead ECG at screening include, but are not limited to, a Mean QTcF \> 450 ms for males or \> 470 ms for females. The measurement is taken while the subject is supine after resting for at least 10 minutes, with three readings obtained at intervals of at least 1 minute. If the mean QTcF exceeds these limits, the ECG measurement should be repeated three times. If the retest results are still abnormal, the subject is excluded.
✕. Clinically significant abnormalities in laboratory tests, chest X-ray, and/or abdominal ultrasound at Screening unless the Investigator determines they are non-interfering.
✕. 25-hydroxyvitamin D3 concentration \< 20 ng/mL at screening and unwilling to supplement vitamin D.
✕. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and/or total bilirubin (TBIL) levels exceeding the upper limit of normal (ULN) at screening.
✕. International normalized ratio (INR) greater than 1.5 at screening.
✕. Corrected serum calcium and phosphorus levels outside the laboratory reference range at Screening (calcium and phosphorus supplements should not be taken for at least 8 hours before measuring serum calcium and phosphorus).
✕. Estimated creatinine clearance \<60 mL/min (using the Cockcroft-Gault formula) at screening.