Phase I Clinical Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of LYN101

NCT07178327 | Enrolling By Invitation Phase 1

• 2 other identifiers: LYN101CN001CTR20253437
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Osteoporotic Fracture

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related during study

  Up to Day 91 from dosing in part A. Up to 265 from first dosing in part B.

Secondary Outcomes (8)

• Bone turnover markers

  Up to Day 91 in part A. Up to 265 in part B.

• Peak serum concentration (Cmax)

  UP to Day 91 in part A. Up to Day 265 in part B

• Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of LYN101

  Up to Day 91 in part A. Up to Day 265 in part B.

• Time to cmax (Tmax) of LYN101

  Up to Day 91 in part A. Up to Day 265 in part B.

• Observed plasma concentration at the end of a dosing interval (Ctrough) of LYN101

  Up to Day 265 in part B.

Other Outcomes (1)

• Bone mineral density

  Up to Day 91 in part A. Up to Day 265 in part B

Study Arms (2)

LYN101

EXPERIMENTAL

In part A, up to 4 single ascending dose cohorts. In part B, one or additional doses for multiple dose cohorts.

Drug: LYN101

Placebo

PLACEBO COMPARATOR

Eligible participants will receive the matched placebo via SC injection.

Drug: Placebo

Interventions

LYN101 DRUG

In Part A, participants will receive single dose of LYN101 administered as a subcutaneous (SC) injection. In Part B, participants will receive multiple doses of LYN101 administered as a SC injection.

LYN101

Placebo DRUG

In Part A, participants will receive single dose of the matched placebo administered as a subcutaneous (SC) injection (4 cohorts). In Part B, participants will receive multiple doses of the matched placebo administered as a SC injection.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Low bone mass, as measured by Dual Energy X-ray Absorptiometry (DXA) during screening (BMD), shall meet the criteria if any site has a T-score less than -1.0 and greater than -2.5 at the lumbar spine L1-L4, femoral neck, or total hip.

You may not qualify if:

• 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.
• PR interval \< 120 ms PR interval \> 200 ms
• Clinically significant abnormalities in laboratory tests, chest X-ray, and/or abdominal ultrasound at Screening unless the Investigator determines they are non-interfering.
• 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.
• Any disease that might impact the safety evaluation of the subject or the in vivo process of the investigational product, including the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematopoietic system, metabolic endocrine system, and others.
• Participation in any other drug or device clinical trials within 30 days or five half-lives (whichever is longer) before screening.
• Use of prescription drugs within 14 days or five half-lives (whichever is longer) before administering the investigational product, unless the Investigator and Sponsor determine they are non-interfering (e.g., hormonal contraceptives).
• Use of over-the-counter (OTC) drugs within 7 days or five half-lives (whichever is longer) before administering the investigational product, unless the Investigator and Sponsor determine they are non-interfering.
• Test results show positive for the hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, Treponema pallidum antibody, or human immunodeficiency virus (HIV) antibody.
• Use of more than 10 sticks per day of tobacco or nicotine products within the past 30 days before screening.

Sponsors & Collaborators

• Shanghai TTM-Bio Technology Co., Ltd: lead

Study Sites (2)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233060, China

Location

Shanghai Sixth People's Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Osteoporotic Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• Huan Zhou

  The First Affiliated Hospital of Bengbu Medical University

  STUDY DIRECTOR

• Huan Zhou, Dr

  The First Affiliated Hospital of Bengbu Medical University

  PRINCIPAL INVESTIGATOR

• Lin Zhen Zhang, Dr

  Shanghai 6th People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 17, 2025
• Study Start: September 6, 2025
• Primary Completion (Estimated): September 6, 2026
• Study Completion (Estimated): September 6, 2027
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)