Osteonecrosis of the Femoral HeadPhase 1LLP2A-AleNCT07545018

RAB001（LLP2A-Ale） in Healthy Subjects

A Phase 1 study testing RAB001 400 μg/kg group, RAB001 750 μg/kg group and Normal saline in people with Osteonecrosis of the Femoral Head, run by ZhongShan LaiBo RuiChen BioMedicine Co.,Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This trial is a single center, randomized, double-blind, placebo-controlled dose escalation study aimed at examining the safety, tolerability, and pharmacokinetics/pharmacodynamics of single and multiple injections of RAB001 in healthy subjects. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Osteonecrosis of the Femoral Head
What is being tested?: RAB001 400 μg/kg group, RAB001 750 μg/kg group and Normal saline
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 16 participants
Where: 1 siteChina
Study dates: 10 Feb 2023to 5 Jul 2023
Phase: Phase 1
Are there results?: None posted in the registry

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 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male body weight should be at least 50.0 kg, female body weight should be at least 45 kg; body mass index (BMI) should be between 19.0-26.0 kg/m2 (including boundary values);
Can understand the informed consent form, voluntarily participate and sign the informed consent form;
Capable of completing experiments in accordance with the research protocol.

Who cannot join

During the screening period, vital signs, physical examination, 12 lead electrocardiogram examination, and laboratory tests (including blood routine, urine routine, blood biochemistry, and coagulation function) were determined by the researchers to be clinically significant abnormalities;
Suffering from the blood system, circulatory system, and digestive system Individuals with a history of serious clinical diseases such as systemic, urinary, respiratory, nervous, immune, endocrine, malignant tumors, mental disorders, and metabolic abnormalities, or any other diseases or physiological conditions that can interfere with test results;
Individuals with a significant history of allergic reactions in clinical practice, especially drug allergies, or those known to be allergic to this product;
Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody and treponema pallidum (TP) antibody test, any of which is positive;
Individuals with positive urine screening for drug abuse (including morphine, methamphetamine, ketamine, methylenedioxymethamphetamine, tetrahydrocannabinol);
Individuals with a history of drug use or substance abuse (including the use of prohibited substances for medical use and controlled drugs);

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Screening for those who have undergone critical surgery within the previous 3 months or plan to undergo surgery during the trial period, as well as those who have undergone surgery that may affect drug absorption, distribution, metabolism, and excretion;
Screening participants who have participated in any clinical trial as subjects within the first 3 months;
Individuals who have donated blood or lost blood/plasma greater than 400 mL within the first 3 months of screening (excluding female physiological bleeding);
Alcoholics (i.e. males drinking more than 28 standard units of alcohol per week and females drinking more than 21 standard units of alcohol per week, with 1 standard unit containing 14 g of alcohol, such as 360 mL of beer or 45 mL of 40% spirits or 150 mL of wine) or those who have frequently consumed alcohol (i.e. drinking more than 14 standard units of alcohol per week) within the 6 months prior to screening, or those who cannot abstain from alcohol during the trial period, or those who have a positive breathalyzer test;
Individuals who have taken any prescription or over-the-counter drugs, as well as any functional vitamins or herbal products within the 14 days prior to screening;
Those who have consumed excessive amounts of tea, coffee, or caffeinated beverages for a long time in the past (8 or more cups per day, 1 cup=250 mL);
It cannot be guaranteed that vigorous exercise, smoking, and special diets (including grapefruit, chocolate, tea, cola, or any caffeinated food or beverage, alcoholic beverage, or other food or beverage that affects drug absorption, distribution, metabolism, or excretion) will be prohibited from 48 hours before administration until the last blood collection;
Pregnant or lactating women, or female subjects who have had unprotected sex within two weeks prior to screening, or female subjects who have a positive blood pregnancy test; Female and male participants (or their partners) who have had fertility plans or donated sperm/eggs throughout the entire trial period and within 6 months after the end of the study, and who are unwilling to use one or more contraceptive measures during the trial period and within 6 months after the end of the study;
Those who cannot tolerate venipuncture or difficulty in venous blood collection;
Individuals with a history of fainting from needles or blood, or known severe bleeding tendencies;
Those who have special dietary requirements and cannot follow a uniform diet;
The researchers believe that there are any circumstances that may affect the provision of informed consent or adherence to the trial protocol by the subjects, or that the participation of the subjects in the trial may affect the trial results or their own safety.

Trial locations and contacts

1 site in 1 country.

China1 site

Hebei University Affiliated Hospital
Baoding, Hebei, 071000

Other trials in China

About this study

Official title: A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of RAB001 in Healthy Subjects

According to the results of Phase I clinical trials abroad, two dose groups (400 μ g/kg and 750 μ g/kg) were established, with 8 healthy subjects enrolled in each dose group (6 in the experimental group and 2 in the placebo group), for a total of 16 healthy subjects. Each dose group is divided into two stages.

Phase 1: Single dose administration phase Subjects who meet the inclusion criteria will first undergo a single dose study in the 400 μ g/kg dose group. Blood samples will be collected at predetermined time points for single dose PK, PD, and immunogenicity evaluation. After the single dose, safety and tolerance data will be collected for 14 days. If the subjects are tolerant, a single dose study in the 750 μ g/kg dose group can be conducted. After the dose increases to the maximum dose of 750 μ g/kg as designed in this experiment, the next dose will not be administered.

Phase 2: Multiple administration phase Single dose administration is combined with multiple dose administration. If the subjects can tolerate it during the single dose phase, they will enter the multiple dose study phase, which will be administered once every 2 weeks, on days 15, 29, and 43 respectively. Collect blood samples at predetermined time points for PK, PD, and immunogenicity evaluation, observe for 14 days after the last administration, and collect safety and tolerability data.

This experiment adopts a step-by-step increasing method for dose escalation, and the next dose group must complete the safety and tolerability evaluation of a single dose in the previous dose group before starting. Each subject only receives one corresponding dose.

Conditions: Osteonecrosis of the Femoral Head
Being tested: RAB001 400 μg/kg group, RAB001 750 μg/kg group, Normal saline
Keywords: Osteonecrosis
Medical subject headings: Legg-Calve-Perthes Disease, Osteonecrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RAB001 400 μg/kg groupDrug
The subjects received intravenous administration of RAB001 400 μ g/kg on day 1、15、29、43
RAB001 750 μg/kg groupDrug
The subjects received intravenous administration of RAB001 750 μ g/kg on day 1、15、29、43
Normal salineDrug
The subjects received intravenous administration of normal saline on day 1、15、29、43

Study groups in NCT07545018
Study group	Role	What they receive
experimental group	Experimental	The subjects received intravenous administration of RAB001 Receives: Drug: RAB001 400 μg/kg group; Drug: RAB001 750 μg/kg group
Control group	Placebo comparator	The subjects received intravenous administration of normal saline Receives: Drug: Normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse events
Adverse events,evaluate the safety of single injections of RAB001 at different doses
Measured: 14 days after single injections
Serious adverse events
serious adverse events during the study
Measured: 14 days after single administration
Adverse events
Adverse events evaluate the safety and tolerability of multiple injections of RAB001 at different doses
Measured: 14 days after multiple administrations
Serious adverse events
Serious adverse events during the study，evaluate the safety of multiple injections of RAB001 at different doses
Measured: 14 days after multiple administrations

Secondary outcomes (14)

PK parameter Cmax
PK parameter Cmax :Maximum peak plasma concentration (Cmax)
Measured: The 0-24 hours after dosing on Day 1 and the 0-24 hours after dosing on Day 15
PK parameter AUC0-t
PK parameter AUC0-t:Area under the concentration-time curve (AUC0-t) from time zero to time "t" .
Measured: The 0-24 hours after dosing on Day 1 and the 0-24 hours after dosing on Day 15.
PK parameter AUC0-∞
PK parameter AUC0-∞:AUC from time zero to infinity (AUC0-∞) .
Measured: The 0-24 hours after dosing on Day 1 and the 0-24 hours after dosing on Day 15.
PK parameter Tmax
PK parameter Tmax.Time of Cmax (Tmax).
Measured: The 0-24 hours after dosing on Day 1 and the 0-24 hours after dosing on Day 15.
PK parameter T1/2z
PK parameter T1/2z:Terminal-phase elimination half-life (t1/2) .
Measured: The 0-24 hours after dosing on Day 1 and the 0-24 hours after dosing on Day 15.
PK parameter-Vz/F
PK parameter-Vz/F:Apparent Volume of Distribution During the Terminal Phase (Vz/F) of RAB001 in Plasma
Measured: The 0-24 hours after dosing on Day 1 and the 0-24 hours after dosing on Day 15.
PK parameter-CL
PK parameter-CL:Systemic Clearance (CL) of RAB001
Measured: The 0-24 hours after dosing on Day 1 and the 0-24 hours after dosing on Day 15.
PK parameter λz
PK parameter λz:Apparent Terminal Elimination Rate Constant (λZ) of
Measured: The 0-24 hours after dosing on Day 1 and the 0-24 hours after dosing on Day 15.
PK Parameter: CLss
PK Parameter: CLss , the apparent systemic clearance from plasma observed during a dosing interval at steady state following extravascular administration
Measured: The 0-24 hours after dosing on Day 1 and the 0-24 hours after dosing on Day 15.
Bone turnover marker: BALP
Change in Serum Bone Alkaline Phosphatase (BALP) Level
Measured: Day 1、8 、15、29、43 、 57
Bone turnover marker: PINP levels
PINP (N-terminal Propeptide of Type I Procollagen) Bone Turnover Marker Levels
Measured: Day 1、8 、15、29、43 、57
Bone turnover marker: Osteocalcin (OC) Levels
the bone turnover marker : Osteocalcin (OC) Levels
Measured: Day 1、8 、15、29、43 、 57
Bone turnover marker:CTX-I Levels
CTX-I (C-terminal Telopeptide of Type I Collagen )Levels the bone turnover marker
Measured: Day 1、8 、15、29、43 、57
Bone turnover marker: VEGF
Bone turnover marker: VEGF vascular endothelial growth factor
Measured: Day 1、8 、15、29、43、57

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Feb 20235 Jul 2023

First posted22 Apr 2026
Study start10 Feb 2023
Primary completion5 Jul 2023
Study completion5 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Osteonecrosis of the Femoral HeadStudies 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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07545018
Sponsor's protocol ID: ZSLBRC_RAB001-PHI
Acronym: LLP2A-Ale
Status last verified: Apr 2026
First submitted: 2 Apr 2026
Last updated: 22 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of RAB001 in Healthy Subjects
ClinicalTrials.gov ID: NCT07545018
Acronym / sponsor ID: LLP2A-Ale / ZSLBRC_RAB001-PHI
Conditions: Osteonecrosis of the Femoral Head
Keywords: Osteonecrosis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: ZhongShan LaiBo RuiChen BioMedicine Co.,Ltd.Other government
Study start: 10 Feb 2023 (actual)
Primary completion: 5 Jul 2023 (actual)
Study completion: 5 Jul 2023 (actual)
First posted: 22 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.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
experimental group	Experimental	Drug: RAB001 400 μg/kg group, Drug: RAB001 750 μg/kg groupThe subjects received intravenous administration of RAB001
Control group	Placebo comparator	Drug: Normal salineThe subjects received intravenous administration of normal saline

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Male body weight should be at least 50.0 kg, female body weight should be at least 45 kg; body mass index (BMI) should be between 19.0-26.0 kg/m2 (including boundary values);
Can understand the informed consent form, voluntarily participate and sign the informed consent form;
Capable of completing experiments in accordance with the research protocol.

Key exclusion criteria (18 listed)

During the screening period, vital signs, physical examination, 12 lead electrocardiogram examination, and laboratory tests (including blood routine, urine routine, blood biochemistry, and coagulation function) were determined by the researchers to be clinically significant abnormalities;
Suffering from the blood system, circulatory system, and digestive system Individuals with a history of serious clinical diseases such as systemic, urinary, respiratory, nervous, immune, endocrine, malignant tumors, mental disorders, and metabolic abnormalities, or any other diseases or physiological conditions that can interfere with test results;
Individuals with a significant history of allergic reactions in clinical practice, especially drug allergies, or those known to be allergic to this product;
Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody and treponema pallidum (TP) antibody test, any of which is positive;
Individuals with positive urine screening for drug abuse (including morphine, methamphetamine, ketamine, methylenedioxymethamphetamine, tetrahydrocannabinol);

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
RAB001 400 μg/kg groupThe subjects received intravenous administration of RAB001 400 μ g/kg on day 1、15、29、43	Drug	experimental group
RAB001 750 μg/kg groupThe subjects received intravenous administration of RAB001 750 μ g/kg on day 1、15、29、43	Drug	experimental group
Normal salineThe subjects received intravenous administration of normal saline on day 1、15、29、43	Drug	Control group

Primary outcome

Adverse events
Time frame: 14 days after single injections
Adverse events,evaluate the safety of single injections of RAB001 at different doses
Serious adverse events
Time frame: 14 days after single administration
serious adverse events during the study
Adverse events
Time frame: 14 days after multiple administrations
Adverse events evaluate the safety and tolerability of multiple injections of RAB001 at different doses
Serious adverse events
Time frame: 14 days after multiple administrations
Serious adverse events during the study，evaluate the safety of multiple injections of RAB001 at different doses

14 secondary outcomes

PK parameter Cmax
Time frame: The 0-24 hours after dosing on Day 1 and the 0-24 hours after dosing on Day 15
PK parameter AUC0-t
Time frame: The 0-24 hours after dosing on Day 1 and the 0-24 hours after dosing on Day 15.
PK parameter AUC0-∞
Time frame: The 0-24 hours after dosing on Day 1 and the 0-24 hours after dosing on Day 15.
PK parameter Tmax
Time frame: The 0-24 hours after dosing on Day 1 and the 0-24 hours after dosing on Day 15.
PK parameter T1/2z
Time frame: The 0-24 hours after dosing on Day 1 and the 0-24 hours after dosing on Day 15.
PK parameter-Vz/F
Time frame: The 0-24 hours after dosing on Day 1 and the 0-24 hours after dosing on Day 15.
PK parameter-CL
Time frame: The 0-24 hours after dosing on Day 1 and the 0-24 hours after dosing on Day 15.
PK parameter λz
Time frame: The 0-24 hours after dosing on Day 1 and the 0-24 hours after dosing on Day 15.
PK Parameter: CLss
Time frame: The 0-24 hours after dosing on Day 1 and the 0-24 hours after dosing on Day 15.
Bone turnover marker: BALP
Time frame: Day 1、8 、15、29、43 、 57
Bone turnover marker: PINP levels
Time frame: Day 1、8 、15、29、43 、57
Bone turnover marker: Osteocalcin (OC) Levels
Time frame: Day 1、8 、15、29、43 、 57
Bone turnover marker:CTX-I Levels
Time frame: Day 1、8 、15、29、43 、57
Bone turnover marker: VEGF
Time frame: Day 1、8 、15、29、43、57

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 18 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: finished, as of the sponsor's last update on 22 Apr 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Adverse events (time frame: 14 days after single injections). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07545018.

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 22 Apr 2026.