Osteoporotic FracturePhase 1NCT07178327
Phase I Clinical Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of LYN101
A Phase 1 study testing LYN101 in people with Osteoporotic Fracture, run by Shanghai TTM-Bio Technology Co., Ltd at 2 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporotic Fracture
- What is being tested?
- LYN101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesChina
- Study dates
- 6 Sep 2025to 30 Mar 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
- 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.
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- 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.
- History of alcohol, drug, or substance abuse within the 12 months before screening.
- Known allergy to human immunoglobulins, the investigational product or its components, calcium preparations, or vitamin D preparations.
- Receiving a live vaccine (excluding influenza vaccine) within 4 weeks before screening, or planning to receive a live vaccine during the study.
- Blood donation or blood loss of 400 mL or more within the past thirty days before screening.
- Pregnant or breastfeeding women.
- Any condition that, in the investigator's opinion, makes the subject unsuitable for enrollment or may interfere with the subject's participation or completion of the study.
- Presence of bone metabolic diseases such as hypoparathyroidism, hyperparathyroidism, hypothyroidism, hyperthyroidism, hypopituitarism, hyperprolactinemia, Cushing's syndrome, acromegaly, Paget's disease, rheumatoid arthritis, osteomalacia, among others; individuals with stable hypothyroidism (for at least three months) on thyroid hormone replacement therapy may be eligible for enrollment, provided they meet the following criteria: a TSH level ranging from 4.0 to 10.0 μIU/mL and serum FT4 within the normal range.
- The following medications that may affect bone metabolism have been received: glucocorticoids (≥ prednisone 5 mg/day or equivalent, taken for at least 10 consecutive days), vitamin K, calcitonin preparations, selective estrogen receptor modulators, sex hormone preparations (excluding vaginal tablets and creams for vaginal use), immunomodulatory agents (such as cyclosporine, tacrolimus, etc.), or methotrexate (excluding calcium and vitamin D supplements) within the past two months; alternatively, bisphosphonates used within the 12 months before screening or used continuously for more than one year within the last two years; or the use of parathyroid hormone (PTH) analogs, anti-RANK ligand (RANKL) antibodies, cathepsin K inhibitors, or anti-Sclerostin antibodies.
- 25-hydroxyvitamin D3 concentration < 20 ng/mL at screening, except for those who agree to vitamin D supplementation to meet the requirement;
- Estimated creatinine clearance below 60 mL/min (Cockcroft-Gault formula) during screening.
- Corrected serum calcium levels were outside the laboratory reference range at screening. (Calcium preparations should not be taken for at least 8 hours before measuring serum calcium during screening.)
- Systolic blood pressure (SBP) is 140 mmHg or higher, and/or diastolic blood pressure (DBP) is 90 mmHg or higher, after at least five minutes of rest during screening.
- Mean QTcF >470 ms at Screening (measured supine after resting for at least 10 minutes, 3 times with at least 1 minute interval); If the mean QTcF exceeds this limit, repeat the 12-lead ECG measurement 3 times; if the results of the retest are still abnormal, the subject is excluded.
- Clinically significant cardiovascular, respiratory, digestive, dermatological, urinary, hematological, neurological, psychiatric, or other systemic diseases or laboratory abnormalities, and if the investigator determines the subject is unsuitable for participation.
- Malignancy within the past 5 years (except completely resected in-situ basal cell or squamous cell skin cancer, cervical carcinoma in situ, or ductal carcinoma in situ of the breast).
- Known active tuberculosis.
- Positive for HBsAg, HCV antibody, HIV antibody, or Treponema pallidum antibody.
- Participation in any other drug or device clinical trials within 30 days or five half-lives (whichever is longer) before screening.
- Known prior use of humanized IgG antibodies.
- Known allergies to human immunoglobulins, the investigational product, its components, calcium supplements, or vitamin D supplements.
- Receiving a live vaccine (excluding influenza vaccine) within 4 weeks before screening, or planning to receive a live vaccine during the study.
- History of alcohol, drug, or substance abuse.
- Fragility fracture within six months before enrollment or when the Investigator considers subjects to be at high risk of fragility fracture requiring treatment with active medications (other than calcium and vitamin D supplements) (Fragility fracture: a fracture occurring under normal or minimal external force due to the inherent fragility of the bone).
- Any condition that, in the Investigator's opinion, makes the subject unsuitable for enrollment or may interfere with the subject's participation or completion of the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233060
Shanghai Sixth People's Hospital
Shanghai
About this study
Official title: A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Administration of LYN101 in Healthy Subjects and Multiple Administrations in Postmenopausal Women With Low Bone Mass
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).
Read the detailed description
The study includes Part A and Part B. Up to four dose levels will be tested in the single ascending dose stage, involving approximately 32 healthy volunteer subjects, with eight subjects per dose level (Part A). After completing Part A, one dose level or additional optional levels will be tested in multiple doses in Part B, enrolling about 32 postmenopausal women with low bone mass. In both Part A and Part B, eligible subjects will be randomized in a 3:1 ratio to receive either LYN101 or a matched placebo.
- Conditions
- Osteoporotic Fracture
- Being tested
- LYN101, Placebo
- Medical subject headings
- Osteoporotic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LYN101Drug
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.
PlaceboDrug
In Part A, participants will receive single dose of the matched placebo administered as a subcutaneous (SC) injection.
In Part B, participants will receive multiple doses of the matched placebo administered as a SC injection.
| Study group | Role | What they receive |
|---|---|---|
| LYN101 | Experimental | In part A, up to 4 single ascending dose cohorts. In part B, up to 4 multiple dose cohorts. Receives: Drug: LYN101 |
| Placebo | Placebo comparator | Eligible participants will receive the matched placebo via SC injection. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to Day 91 from dosing in part A. Up to 175 from first dosing in part B.
Secondary outcomes (8)
Bone turnover markers
The changes from baseline following LYN101 SC administration.
Measured: Up to Day 91 in part A. Up to 175 in part B.
Peak serum concentration (Cmax)
Cmax of LYN101.
Measured: UP to Day 91 in part A. Up to Day 175 in part B
Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of LYN101
AUCtau of LYN101.
Measured: Up to Day 91 in part A. Up to Day 175 in part B.
Time to cmax (Tmax) of LYN101
Tmax of LYN101
Measured: Up to Day 91 in part A. Up to Day 175 in part B.
Observed plasma concentration at the end of a dosing interval (Ctrough) of LYN101
Ctrough of LYN101
Measured: Up to Day 175 in part B.
Terminal Phase Elimination Half-Life (t1/2) of LYN101
T1/2 of LYN101.
Measured: Up to Day 91 in part A. Up to Day 175 in part B.
Clearance (CL) for LYN101 SC
CL for LYN101 SC.
Measured: Up to Day 91 in part A. Up to Day 175 in part B.
Immunogenicity of LYN101 assessed by anti-drug antibodies (ADAs)
Incidence and concentrations of ADAs. Neutralizing ADAs (NAb) may be evaluated.
Measured: Up to Day 91 in part A. Up to Day 175 in part B.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start6 Sep 2025
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporotic FractureStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai TTM-Bio Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huan Zhou, Study director, The First Affiliated Hospital of Bengbu Medical UniversityHuan Zhou, Dr, Principal investigator, The First Affiliated Hospital of Bengbu Medical UniversityLin Zhen Zhang, Dr, Principal investigator, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178327
- Sponsor's protocol ID
- LYN101CN001
- Other IDs
- CTR20253437
- Status last verified
- Aug 2026
- First submitted
- 10 Sep 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Administration of LYN101 in Healthy Subjects and Multiple Administrations in Postmenopausal Women With Low Bone Mass
- ClinicalTrials.gov ID
- NCT07178327
- Acronym / sponsor ID
- LYN101CN001
- Conditions
- Osteoporotic Fracture
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Shanghai TTM-Bio Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2025 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 17 Sep 2025 (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 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).
Detailed description
The study includes Part A and Part B. Up to four dose levels will be tested in the single ascending dose stage, involving approximately 32 healthy volunteer subjects, with eight subjects per dose level (Part A). After completing Part A, one dose level or additional optional levels will be tested in multiple doses in Part B, enrolling about 32 postmenopausal women with low bone mass. In both Part A and Part B, eligible subjects will be randomized in a 3:1 ratio to receive either LYN101 or a matched placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LYN101 | Experimental | Drug: LYN101In part A, up to 4 single ascending dose cohorts. In part B, up to 4 multiple dose cohorts. |
| Placebo | Placebo comparator | Drug: PlaceboEligible participants will receive the matched placebo via SC injection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (39 listed)
- 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.
- 25-hydroxyvitamin D3 concentration < 20 ng/mL at screening and unwilling to supplement vitamin D.
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 |
|---|---|---|
| LYN101In 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. | Drug | LYN101 |
| PlaceboIn Part A, participants will receive single dose of the matched placebo administered as a subcutaneous (SC) injection. In Part B, participants will receive multiple doses of the matched placebo administered as a SC injection. | Drug | Placebo |
Primary outcome
Number of participants with adverse events
Time frame: Up to Day 91 from dosing in part A. Up to 175 from first dosing in part B.
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
8 secondary outcomes
Bone turnover markers
Time frame: Up to Day 91 in part A. Up to 175 in part B.
Peak serum concentration (Cmax)
Time frame: UP to Day 91 in part A. Up to Day 175 in part B
Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of LYN101
Time frame: Up to Day 91 in part A. Up to Day 175 in part B.
Time to cmax (Tmax) of LYN101
Time frame: Up to Day 91 in part A. Up to Day 175 in part B.
Observed plasma concentration at the end of a dosing interval (Ctrough) of LYN101
Time frame: Up to Day 175 in part B.
Terminal Phase Elimination Half-Life (t1/2) of LYN101
Time frame: Up to Day 91 in part A. Up to Day 175 in part B.
Clearance (CL) for LYN101 SC
Time frame: Up to Day 91 in part A. Up to Day 175 in part B.
Immunogenicity of LYN101 assessed by anti-drug antibodies (ADAs)
Time frame: Up to Day 91 in part A. Up to Day 175 in part B.
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 2 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Huan Zhou study director
The First Affiliated Hospital of Bengbu Medical University
Huan Zhou, Dr principal investigator
The First Affiliated Hospital of Bengbu Medical University
Lin Zhen Zhang, Dr principal investigator
Shanghai 6th People's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LYN101 in people with Osteoporotic Fracture, run by Shanghai TTM-Bio Technology Co., Ltd at 2 sites in China.
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 9 inclusion and 39 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: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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. Some participants in this study may receive a placebo. 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?
Number of participants with adverse events (time frame: Up to Day 91 from dosing in part A. Up to 175 from first dosing in part B.). 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 2 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.