Idiopathic Pulmonary FibrosisPhase 1NCT04986540
A Trial of SHR - 1906 in Healthy Subjects
A Phase 1 study of Idiopathic Pulmonary Fibrosis, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
This study is a phase 1 single dose escalation study of SHR-1906 in healthy subjects. The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of SHR-1906 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2021to 7 Sep 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial, and provides written informed consent, be able to comply with all the requirements and able to complete the study.
- Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
- Total body weight ≥ 45 kg.
- No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry, coagulation function and thyroid function) and ECG at the investigator's discretion during screening and baseline
- Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods
Who cannot join
- History of serious cardiovascular, liver, kidney, digestive tract, psychiatric, hematology, metabolic disorders, primary immunodeficiency disease or acquired immune deficiency syndrome, or organ transplantation.
- Severe infections, injuries or major surgeries (as determined by the investigator) within 6 months prior to screening, or plan to do any surgery during the trial.
- Positive testing for human immunodeficiency virus (HIV-Ab), or hepatitis B surface antigen (HBsAg), or TP-Ab , or hepatitis C antibodies (HCV-Ab).
- Screening/baseline systolic blood pressure (BP) ≥140 mmHg or ≤90 mmHg; diastolic BP ≥90 mmHg or <60 mmHg on a single measurement
- Positive urine drug screening at baseline;
- Use of any medicine within 1 monthes (including any prescription, or over-the-counter medicine, herbal remedy or nutritional supplement, except for vitamins and occasional use of acetaminophen with recommended dose), or within 5 half-lives of any drugs whichever is longer prior to dosing, or plan to use any medicine during the trial.
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- Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening or within 5 half-lives of any drugs during screening visit, or in the follow-up period of a clinical study whichever is longer (according to the date of signed consent form) which is defined as having consented and used other investigational drugs (including placebo) or trial medical devices.
- Blood donation or loss of ≥ 400 mL of blood within 1 months; or received blood or blood products within 2 months prior to screening.
- Any other circumstances that, in the investigator's judgment, may increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response.
- Researchers and relevant staff of the research center or other persons directly involved in the implementation of the program.
Trial locations and contacts
1 site in 1 country.
China1 site
Phase I Clinical Research Unit, Qianfoshan Hospital of Shandong Province
Jinan, Shandong, 250014
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single IV Infusion of SHR-1906 in Healthy Subjects
This study is a phase 1 single dose escalation study of SHR-1906 in healthy subjects. The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of SHR-1906 in healthy subjects.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- SHR-1906；Placebo
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1906；PlaceboDrug
Drug: SHR-1906 IV, single dose
Drug: Placebo IV, single dose
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | A single subcutaneous injection of SHR-1906/placebo dose 1 in healthy subjects Receives: Drug: SHR-1906；Placebo |
| Cohort 2 | Experimental | A single subcutaneous injection of SHR-1906/placebo dose 2 in healthy subjects Receives: Drug: SHR-1906；Placebo |
| Cohort 3 | Experimental | A single subcutaneous injection of SHR-1906/placebo dose 3 in healthy subjects Receives: Drug: SHR-1906；Placebo |
| Cohort 4 | Experimental | A single subcutaneous injection of SHR-1906/placebo dose 4 in healthy subjects Receives: Drug: SHR-1906；Placebo |
| Cohort 5 | Experimental | A single subcutaneous injection of SHR-1906/placebo dose 5 in healthy subjects Receives: Drug: SHR-1906；Placebo |
| Cohort 6 | Experimental | A single subcutaneous injection of SHR-1906/placebo dose 6 in healthy subjects Receives: Drug: SHR-1906；Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Incidence and severity of adverse events
Measured: Start of Treatment to end of study (approximately 10 weeks)
Secondary outcomes (8)
Pharmacokinetics-AUC0-last
Area under the concentration-time curve from time 0 to last time point after SHR-1906 administration
Measured: Start of Treatment to end of study (approximately 10 weeks)
Pharmacokinetics-AUC0-inf
Area under the concentration-time curve from time 0 to infinity after SHR-1906 administration
Measured: Start of Treatment to end of study (approximately 10 weeks)
Pharmacokinetics-Tmax
Time to Cmax of SHR-1906
Measured: Start of Treatment to end of study (approximately 10 weeks)
Pharmacokinetics-Cmax
Maximum observed concentration of SHR-1906
Measured: Start of Treatment to end of study (approximately 10 weeks)
Pharmacokinetics-CL
Clearance of SHR-1906
Measured: Start of Treatment to end of study (approximately 10 weeks)
Pharmacokinetics-V
Volume of distribution during terminal phase of SHR-1906
Measured: Start of Treatment to end of study (approximately 10 weeks)
Pharmacokinetics-t1/2
Terminal elimination half-life of SHR-1906
Measured: Start of Treatment to end of study (approximately 10 weeks)
Anti-Drug antibody
The percentage of subjects with positive ADA titers over time for SHR-1906
Measured: Start of Treatment to end of study (approximately 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start10 Aug 2021
- Primary completion7 Sep 2022
- Study completion7 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Guangdong Hengrui Pharmaceutical Co., LtdThe sponsor's other registered studies.
- 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
- Model description
- SHR-1906 compared with placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986540
- Sponsor's protocol ID
- SHR-1906-101
- Status last verified
- Feb 2023
- First submitted
- 27 Jul 2021
- Last updated
- 16 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single IV Infusion of SHR-1906 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04986540
- Acronym / sponsor ID
- SHR-1906-101
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 7 Sep 2022 (actual)
- Study completion
- 7 Sep 2022 (actual)
- First posted
- 3 Aug 2021 (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 study is a phase 1 single dose escalation study of SHR-1906 in healthy subjects. The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of SHR-1906 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- SHR-1906 compared with placebo
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: SHR-1906；PlaceboA single subcutaneous injection of SHR-1906/placebo dose 1 in healthy subjects |
| Cohort 2 | Experimental | Drug: SHR-1906；PlaceboA single subcutaneous injection of SHR-1906/placebo dose 2 in healthy subjects |
| Cohort 3 | Experimental | Drug: SHR-1906；PlaceboA single subcutaneous injection of SHR-1906/placebo dose 3 in healthy subjects |
| Cohort 4 | Experimental | Drug: SHR-1906；PlaceboA single subcutaneous injection of SHR-1906/placebo dose 4 in healthy subjects |
| Cohort 5 | Experimental | Drug: SHR-1906；PlaceboA single subcutaneous injection of SHR-1906/placebo dose 5 in healthy subjects |
| Cohort 6 | Experimental | Drug: SHR-1906；PlaceboA single subcutaneous injection of SHR-1906/placebo dose 6 in healthy subjects |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial, and provides written informed consent, be able to comply with all the requirements and able to complete the study.
- Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
- Total body weight ≥ 45 kg.
- No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry, coagulation function and thyroid function) and ECG at the investigator's discretion during screening and baseline
- Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods
Key exclusion criteria (10 listed)
- History of serious cardiovascular, liver, kidney, digestive tract, psychiatric, hematology, metabolic disorders, primary immunodeficiency disease or acquired immune deficiency syndrome, or organ transplantation.
- Severe infections, injuries or major surgeries (as determined by the investigator) within 6 months prior to screening, or plan to do any surgery during the trial.
- Positive testing for human immunodeficiency virus (HIV-Ab), or hepatitis B surface antigen (HBsAg), or TP-Ab , or hepatitis C antibodies (HCV-Ab).
- Screening/baseline systolic blood pressure (BP) ≥140 mmHg or ≤90 mmHg; diastolic BP ≥90 mmHg or <60 mmHg on a single measurement
- Positive urine drug screening at baseline;
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 |
|---|---|---|
| SHR-1906；PlaceboDrug: SHR-1906 IV, single dose Drug: Placebo IV, single dose | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
Primary outcome
Adverse events
Time frame: Start of Treatment to end of study (approximately 10 weeks)
Incidence and severity of adverse events
8 secondary outcomes
Pharmacokinetics-AUC0-last
Time frame: Start of Treatment to end of study (approximately 10 weeks)
Pharmacokinetics-AUC0-inf
Time frame: Start of Treatment to end of study (approximately 10 weeks)
Pharmacokinetics-Tmax
Time frame: Start of Treatment to end of study (approximately 10 weeks)
Pharmacokinetics-Cmax
Time frame: Start of Treatment to end of study (approximately 10 weeks)
Pharmacokinetics-CL
Time frame: Start of Treatment to end of study (approximately 10 weeks)
Pharmacokinetics-V
Time frame: Start of Treatment to end of study (approximately 10 weeks)
Pharmacokinetics-t1/2
Time frame: Start of Treatment to end of study (approximately 10 weeks)
Anti-Drug antibody
Time frame: Start of Treatment to end of study (approximately 10 weeks)
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 16 Feb 2023.
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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 1 study of Idiopathic Pulmonary Fibrosis, run by Guangdong Hengrui Pharmaceutical 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 5 inclusion and 10 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 16 Feb 2023. 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. 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: Start of Treatment to end of study (approximately 10 weeks)). 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 16 Feb 2023.