HealthyPhase 3NCT06604546
Hyaluronidase Assisted Subcutaneous Infusion
A Phase 3 study testing hyaluronidase in people with Healthy, run by Shanghai Bao Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
A randomised, double-blind, self controlled study to evaluate the pharmacodynamics and safety of recombinant human hyaluronidase assisted subcutaneous infusion in healthy subjects. Recombinant human hyaluronidase or placebo was injected subcutaneously at the prescribed site on the day of administration. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- hyaluronidase
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2024to 10 Aug 2024
- Phase
- Phase 3
- 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
- Must be willing to participate in this study and sign a written informed consent form.
- Male or female, 18 to 60 years of age.
- Male subjects weighing at least 50 kg, female subjects weighing at least 45 kg. Body mass index in the range of 18-28 kg/m2 (including threshold values).
Who cannot join
- Positive for HBsAg, HCV antibody, HIV antibody and syphilis antibody at screening.
- Definite hypersensitivity to recombinant human hyaluronidase for injection or any of the components of its preparation. Severe allergic reaction (e.g. angioedema) to any medication. Special dietary requirements or inability to follow the standard diet required by the clinical trial site.
- Prescription medicines taken within 14 days or 5 half-lives prior to dosing, or over-the-counter medicines (including proprietary Chinese medicines and herbal remedies) taken within 7 days or 5 half-lives prior to dosing. Regular vitamin supplementation was excluded, but special cases of medication that, in the opinion of the investigator, did not interfere with the evaluation of the study could be included.
- Blood donation or blood loss of 400 mL or more in the 3 months prior to screening.
- Heavy smoking (25 or more cigarettes per day).
- Alcohol abuse or a positive breath test result for alcohol.
Show all 14Show fewer
- Positive urine drug screen (including morphine, methamphetamine, ketamine).
- Received another investigational drug (or investigational device) within 28 days or at least 5 half-lives prior to screening, whichever is longer.
- The subject or partner is planning to have a child or is unwilling to use effective contraception during the trial or for 6 months after the end of the trial.
- Nursing or pregnant women.
- Inflammation, tattoos, skin lesions, and scarring on both limbs may interfere with observation and assessment.
- Extremities oedema and limb pathology that may affect test results (e.g. cellulitis, lymphatic disorders or history of surgery, history of mastectomy, history of pre-existing pain syndrome or axillary lymph node dissection).
- Sensorimotor and voluntary movement disorders.
- Circumstances such as the investigator's opinion that participation in the trial is inappropriate or that the subject is unable to participate in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacodynamic Clinical Trail of Recombinant Human Hyaluronidase Assisted Subcutaneous Infusion in Healthy Volunteers
A randomised, double-blind, self controlled study to evaluate the pharmacodynamics and safety of recombinant human hyaluronidase assisted subcutaneous infusion in healthy subjects.
Recombinant human hyaluronidase or placebo was injected subcutaneously at the prescribed site on the day of administration. The prescribed fluid was then infused subcutaneously.
Read more
Subjects in the 150 IU group received a subcutaneous infusion of 500 mL Ringer's lactated sodium into the lateral thighs bilaterally on D1, 250 mL Ringer's lactated sodium into the upper arms bilaterally on D2, 500 mL sodium chloride injection into the lateral thighs bilaterally on D3, and 1,000 mL Ringer's lactated sodium into the back on D4, as scheduled.
Subjects in the 385 IU group received a 250 mL subcutaneous infusion of Ringer's lactated sodium into the bilateral upper arms on D1 as scheduled.
Subjects in the 1500 IU group received a 250 mL subcutaneous infusion of Ringer's lactated sodium into the bilateral upper arms on D1 as scheduled.
Read the detailed description
Hyaluronic acid (HA) is an acidic mucopolysaccharide widely found in connective tissues such as the intercellular matrix of human tissues, the vitreous humour of the eye and the synovial fluid of the joints, and is a component of the tissue matrix that acts to restrict the diffusion of water and other extracellular substances. Its gel-like nature makes it a barrier to subcutaneous fluid diffusion and is an important limitation to subcutaneous infusion. It has also been reported in the literature that lymph nodes, liver and skin are the major metabolic sites of HA, with a metabolic half-life in the skin of approximately 15-20 h. This means that the structure of HA destroyed by enzymatic cleavage can be autonomously rebuilt within 24-48 h. The rapid metabolism characteristics of HA make it an ideal target for action. Hyaluronidase is an endoglycosidase capable of degrading and oligomerising HA. HAase hydrolyses the β-1,4 glycosidic linkage in the HA chain to yield small molecules of HA or oligosaccharides, thereby increasing tissue permeability and improving the permeability of tissues to fluids. HAase has been used in the medical field for many years as a drug diffusing agent, which can promote the diffusion of locally stored drugs, exudate or blood, accelerate the absorption of drugs, reduce local tissue tension and pain, and facilitate the absorption and drainage of oedema and inflammatory exudate. Clinically, HAase is used clinically as an adjunct to subcutaneous infusion.
- Conditions
- Healthy
- Being tested
- hyaluronidase, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyaluronidaseDrug
Also called Lactated Ringer's (LR), Normal Saline (NS)
150 IU group D1:150 IU hyaluronidase+500 ml Lactated Ringer's (LR)(Subject's left or right leg)； D2:150 IU hyaluronidase+250 ml Lactated Ringe's (LR)(Subject's left or right arm)； D3:150 IU hyaluronidase+500 ml Normal Saline (NS)(subject's left or right leg)； D4:150 IU hyaluronidase+1000 ml Lactated Ringer's (LR)(Subject's back)； 385 IU group D1:385 IU hyaluronidase+250 ml Lactated Ringer's (LR)(Subject's left or right arm)； 1500 IU group D1:1500 IU hyaluronidase+250 ml Lactated Ringer's (LR)(Subject's left or right arm).
PlaceboDrug
Also called Lactated Ringer's, Normal Saline
150 IU group D1:Placebo+500 ml Lactated Ringer's (LR)(Subject's left or right leg)； D2:Placeboe+250 ml Lactated Ringer's (LR)(Subject's left or right arm)； D3:Placebo+500 ml Normal Saline (NS)(Subject's left or right leg)； 385 IU group D1:Placebo+250 ml Lactated Ringer's (LR)(Subject's left or right arm)； 1500 IU group D1:Placebo+250 ml Lactated Ringe's (LR)(Subject's left or right arm).
| Study group | Role | What they receive |
|---|---|---|
| hyaluronidase group | Experimental | Not described Receives: Drug: hyaluronidase |
| Placebo self control group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subcutaneous infusion rate.
Subcutaneous infusion Rate: defined as Infusion Rate = (Base Infusion Bag Weighing Weight - Final Infusion Bag Weighing Weight) x (1 mL/g)/(Infusion Completion Time - Infusion Start Time).
Measured: Within 4 hours after starting subcutaneous infusion.
Secondary outcomes (3)
Immunogenicity
antidrug antibodies (ADA) level
Measured: day 21
Measurement value of limb circumference
Limb circumference measurements: Limb circumference measurements were used to assess the pharmacodynamic and safety profile of subcutaneous infusions in healthy volunteers. Limb circumference was measured at the time of each subcutaneous infusion in the upper arm or thigh and at the end of the infusion until the limb circumference returned to baseline (±2 cm).
Measured: day 4
Adverse events
The Investigator will carefully monitor each subject throughout the study for any adverse events (coded to preferred term and system organ class using the Medical Dictionary for Regulatory Activities [MedDRA]). Adverse events assessed by CTCAE v5.0.
Measured: day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start28 Mar 2024
- Primary completion5 May 2024
- Study completion10 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Bao Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604546
- Sponsor's protocol ID
- SHBJ-KJ017-001
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ma H, Lu X, Xiu J, Cao M, Li J, Qiao Y, Liu Y, Wang Z, Zhang L, Qian X, Zhang H, Tang H, Zhao N, Yu Y, Zhang L. Recombinant human hyaluronidase PH20 facilitates rapid subcutaneous infusion: two randomized, double-blind, self-controlled phase III clinical trials. Eur J Pharm Biopharm. 2026 Jun;223:115070. doi: 10.1016/j.ejpb.2026.115070. Epub 2026 Apr 2.
PubMed 41935547
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamic Clinical Trail of Recombinant Human Hyaluronidase Assisted Subcutaneous Infusion in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06604546
- Acronym / sponsor ID
- SHBJ-KJ017-001
- Conditions
- Healthy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Shanghai Bao Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 5 May 2024 (actual)
- Study completion
- 10 Aug 2024 (actual)
- First posted
- 19 Sep 2024 (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.
A randomised, double-blind, self controlled study to evaluate the pharmacodynamics and safety of recombinant human hyaluronidase assisted subcutaneous infusion in healthy subjects.
Recombinant human hyaluronidase or placebo was injected subcutaneously at the prescribed site on the day of administration. The prescribed fluid was then infused subcutaneously.
Subjects in the 150 IU group received a subcutaneous infusion of 500 mL Ringer's lactated sodium into the lateral thighs bilaterally on D1, 250 mL Ringer's lactated sodium into the upper arms bilaterally on D2, 500 mL sodium chloride injection into the lateral thighs bilaterally on D3, and 1,000 mL Ringer's lactated sodium into the back on D4, as scheduled.
Subjects in the 385 IU group received a 250 mL subcutaneous infusion of Ringer's lactated sodium into the bilateral upper arms on D1 as scheduled.
Subjects in the 1500 IU group received a 250 mL subcutaneous infusion of Ringer's lactated sodium into the bilateral upper arms on D1 as scheduled.
Detailed description
Hyaluronic acid (HA) is an acidic mucopolysaccharide widely found in connective tissues such as the intercellular matrix of human tissues, the vitreous humour of the eye and the synovial fluid of the joints, and is a component of the tissue matrix that acts to restrict the diffusion of water and other extracellular substances. Its gel-like nature makes it a barrier to subcutaneous fluid diffusion and is an important limitation to subcutaneous infusion. It has also been reported in the literature that lymph nodes, liver and skin are the major metabolic sites of HA, with a metabolic half-life in the skin of approximately 15-20 h. This means that the structure of HA destroyed by enzymatic cleavage can be autonomously rebuilt within 24-48 h. The rapid metabolism characteristics of HA make it an ideal target for action. Hyaluronidase is an endoglycosidase capable of degrading and oligomerising HA. HAase hydrolyses the β-1,4 glycosidic linkage in the HA chain to yield small molecules of HA or oligosaccharides, thereby increasing tissue permeability and improving the permeability of tissues to fluids. HAase has been used in the medical field for many years as a drug diffusing agent, which can promote the diffusion of locally stored drugs, exudate or blood, accelerate the absorption of drugs, reduce local tissue tension and pain, and facilitate the absorption and drainage of oedema and inflammatory exudate. Clinically, HAase is used clinically as an adjunct to subcutaneous infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyaluronidase group | Experimental | Drug: hyaluronidase |
| Placebo self control group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Must be willing to participate in this study and sign a written informed consent form.
- Male or female, 18 to 60 years of age.
- Male subjects weighing at least 50 kg, female subjects weighing at least 45 kg. Body mass index in the range of 18-28 kg/m2 (including threshold values).
Key exclusion criteria (14 listed)
- Positive for HBsAg, HCV antibody, HIV antibody and syphilis antibody at screening.
- Definite hypersensitivity to recombinant human hyaluronidase for injection or any of the components of its preparation. Severe allergic reaction (e.g. angioedema) to any medication. Special dietary requirements or inability to follow the standard diet required by the clinical trial site.
- Prescription medicines taken within 14 days or 5 half-lives prior to dosing, or over-the-counter medicines (including proprietary Chinese medicines and herbal remedies) taken within 7 days or 5 half-lives prior to dosing. Regular vitamin supplementation was excluded, but special cases of medication that, in the opinion of the investigator, did not interfere with the evaluation of the study could be included.
- Blood donation or blood loss of 400 mL or more in the 3 months prior to screening.
- Heavy smoking (25 or more cigarettes per day).
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 |
|---|---|---|
| hyaluronidaseAlso: Lactated Ringer's (LR), Normal Saline (NS)150 IU group D1:150 IU hyaluronidase+500 ml Lactated Ringer's (LR)(Subject's left or right leg)； D2:150 IU hyaluronidase+250 ml Lactated Ringe's (LR)(Subject's left or right arm)； D3:150 IU hyaluronidase+500 ml Normal Saline (NS)(subject's left or right leg)； D4:150 IU hyaluronidase+1000 ml Lactated Ringer's (LR)(Subject's back)； 385 IU group D1:385 IU hyaluronidase+250 ml Lactated Ringer's (LR)(Subject's left or right arm)； 1500 IU group D1:1500 IU hyaluronidase+250 ml Lactated Ringer's (LR)(Subject's left or right arm). | Drug | hyaluronidase group |
| PlaceboAlso: Lactated Ringer's, Normal Saline150 IU group D1:Placebo+500 ml Lactated Ringer's (LR)(Subject's left or right leg)； D2:Placeboe+250 ml Lactated Ringer's (LR)(Subject's left or right arm)； D3:Placebo+500 ml Normal Saline (NS)(Subject's left or right leg)； 385 IU group D1:Placebo+250 ml Lactated Ringer's (LR)(Subject's left or right arm)； 1500 IU group D1:Placebo+250 ml Lactated Ringe's (LR)(Subject's left or right arm). | Drug | Placebo self control group |
Primary outcome
Subcutaneous infusion rate.
Time frame: Within 4 hours after starting subcutaneous infusion.
Subcutaneous infusion Rate: defined as Infusion Rate = (Base Infusion Bag Weighing Weight - Final Infusion Bag Weighing Weight) x (1 mL/g)/(Infusion Completion Time - Infusion Start Time).
3 secondary outcomes
Immunogenicity
Time frame: day 21
Measurement value of limb circumference
Time frame: day 4
Adverse events
Time frame: day 7
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 23 Sep 2024.
- Derived from this study: PubMed 41935547Ma H, Lu X, Xiu J, Cao M, Li J, Qiao Y, Liu Y, Wang Z, Zhang L, Qian X, Zhang H, Tang H, Zhao N, Yu Y, Zhang L. Recombinant human hyaluronidase PH20 facilitates rapid subcutaneous infusion: two randomized, double-blind, self-controlled phase III clinical trials. Eur J Pharm Biopharm. 2026 Jun;223:115070. doi: 10.1016/j.ejpb.2026.115070. Epub 2026 Apr 2.
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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?
A Phase 3 study testing hyaluronidase in people with Healthy, run by Shanghai Bao Pharmaceuticals Co., Ltd. at 1 site 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 3 inclusion and 14 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 23 Sep 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Subcutaneous infusion rate. (time frame: Within 4 hours after starting subcutaneous infusion.). 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 NCT06604546, which also lists 1 linked publication.
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 23 Sep 2024.