Tolerability, Safety, Immunogenicity and Pharmacokinetic of JS005Phase 1NCT04220073
Phase I Study of Comparing Single Dose JS005 (Recombinant Humanized Monoclonal Antibody Against IL-17A) With Placebo in Tolerability, Safety, Immunogenicity and Pharmacokinetic in Healthy Volunteers
A Phase 1 study testing JS005 (recombinant humanized monoclonal antibody against IL-17A) in people with Tolerability, Safety, Immunogenicity and Pharmacokinetic of JS005, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.
Trial summary
JS005-001 is one randomized, double-blind, placebo-controlled study to evaluate the tolerability, safety, immunogenicity and pharmacokinetic profile of single dose of JS005 injection in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Tolerability, Safety, Immunogenicity and Pharmacokinetic of JS005
- What is being tested?
- JS005 (recombinant humanized monoclonal antibody against IL-17A)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 17 May 2020to 20 Nov 2020
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signature of the informed consent form prior to the study, sufficient understanding of the content, course and possible adverse reactions of the study;
- Being able to complete the study according to the requirements in the study protocol;
- No plan of pregnancy and being willing to use effective contraceptive measures for subject (including partner) from 2 weeks prior to administration to 6 months after the last dose of study drug, see Appendix 5 for the specific contraceptive measures;
- Male and female subjects aged 18 to 45 years, inclusive;
- The body weight no less than 50 kg for male subjects and no less than 45 kg for female subjects. Body mass index (BMI) = weight (kg)/square of height, ranging from 18-26kg/m2 (including the critical value);
- Normal or abnormal and clinically insignificant physical examination, vital signs;
- Good health status, no history of cardiovascular, hepatic, renal, gastrointestinal, neurological, mental or metabolic disorders.
Who cannot join
- Previous use of biopharmaceutical treatment directly targeting IL-17 monoclonal antibody or of IL-17 receptor (e.g., Secukinumab or Ixekizumab) at any time;
- Use of therapeutic biological preparations within 12 weeks prior to administration (on Day 1), or remaining in the elimination period of the drug (within 5 half-lives) at randomization;
- Participation in any other clinical study with intervention of investigational product within 12 weeks prior to randomization (on Day 1), or remaining in the elimination period of the drug (within 5 half-lives) at randomization;
- Vaccination of Bacille Calmette-Guérin vaccine within 12 months prior to administration (on Day 1), or vaccination of other live vaccine within 12 weeks, or plan to use Bacille Calmette-Guérin vaccine or other live vaccine during the study and within 12 weeks after the study;
- Any infection requiring hospitalization, antiviral or antibiotic therapy (e.g., pneumonia, cellulitis, bone and joint infection, etc., the subject is judged by investigators to have weakened immune system and may have unacceptable risk if participating in this study) within 30 days prior to administration (on Day 1);
- Oral administration of herbal medicine within 30 days (inclusive), any prescription drug or over-the-counter drug, including Chinese herbal medicine for external use, vitamins and dietary supplements within 14 days (inclusive) prior to administration;
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- Any major surgery within 8 weeks (inclusive) prior to administration, or requiring such surgery during the study, and such surgery is considered by investigators to possibly bring unacceptable risk for subjects after confirmation by the sponsor;
- Total white blood cell (WBC) count <3500/μl, platelet <100,000/μl, neutrophil <1500/μl or hemoglobin <8.5g/dL at screening;
- Other clinically significant abnormality in clinical laboratory examination, or other clinical findings showing the following disorders of clinical relevance: including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immune, mental or cerebro- and cardiovascular diseases;
- Abnormal ECG at screening (e.g., single QTc [QTcF]> 470 msec for male and > 480 msec for female) and/or other abnormalities of clinical significance, unacceptable risk that may be brought by participation in the study;
- History of HIV infection, and/or positive HIV antibody, positive hepatitis B surface antigen (HBsAg), positive hepatitis C (HCV) antibody, or positive Treponema pallidum serum specific antibody (TP-CIA) at screening;
- History of tuberculosis (TB) infection, or chest X-ray showing TB infection at screening, or tuberculosis screening (T-Spot) showing latent tuberculosis infection;
- History of transplantation of vital organs (e.g., heart, lung, liver, kidney, etc.);
- Having malignant tumors, not including the malignant tumors cured with no recurrence within the recent 5 years, completely resected basal cell and squamous cell carcinoma of skin, completely resected carcinoma in situ of any type);
- Other major diseases within one year;
- Positive urine drug screening, or history of drug abuse or use of narcotics in the past 5 years;
- Positive alcohol test or intake of any alcohol-containing product within 48 hours prior to use of study drug;
- History of excessive drinking or intake of excessive alcohol in the past 6 months (14 units of alcohol per week: 1 unit = 285mL beer, or 25ml liquor, or 100ml wine);
- Known serious allergic reaction or hypersensitive to food, inhaled and contact material as well as drugs, or allergic constitution (allergy to various drugs and food);
- Known history of allergy or hypersensitivity to the study drug, other monoclonal antibody drugs and therapeutic protein preparations (fresh or frozen plasma, human serum albumin, cytokine, interleukin etc.).
- Female subjects with positive serum HCG or who are currently lactating;
- Loss or donation of blood >400mL in recent three months, or receiving blood transfusion; or plan to donate blood during the study;
- Any other condition that the subject is considered by investigators as inappropriate to participate in the study, for example, potential compliance issue, inability to complete all the tests and evaluations according to the requirements in the protocol, or uncontrolled mental, neurological or psychological disorders, participation in the study is judged by investigators to be associated with uncontrollable risk.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Luhe Hospital Capital Medical University
Beijing, Beijing Municipality, 101149
About this study
Official title: Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Tolerability, Safety, Immunogenicity and Pharmacokinetic Profile of Single Dose of JS005 (Recombinant Humanized Monoclonal Antibody Against IL-17A) Injection in Healthy Volunteers
JS005-001 is one randomized, double-blind, placebo-controlled study to evaluate the tolerability, safety, immunogenicity and pharmacokinetic profile of single dose of JS005 injection in healthy volunteers.
A total of 5 dose groups are set in the study, i.e., 15 mg, 60 mg, 150 mg, 300 mg and 600 mg, single dose will be given subcutaneously in abdomen.
Read more
A total of 40 subjects are planned to be enrolled, 8 subjects will be enrolled in each group. Each dose group will be given the study drug and placebo at a ratio of 3:1. Each subject can only receive one single dose at one dose level.
Sentinel method will be used for dose escalation, and one independent safety evaluation team (SET) will be set up. 2 subjects (one receiving study drug, the other receiving placebo) will be randomized preferably and followed up until 3 days after administration when the dose starts in each dose group, the remaining 6 subjects (5 receiving study drug, 1 receiving placebo) can continue to be randomized after confirmation with the sponsor, if no any dose-limiting event (DLE) is observed during that period. Only when all the subjects at present dose level complete the follow-up for at least 14 days after administration, and no dose-limiting event (DLE) is observed in any one subject, the next dose level can be initiated after confirmation with the independent safety evaluation team and the sponsor, otherwise they must be observed for the full term of follow-up (i.e., on Day 85). If DLE is observed throughout the observational period, it is confirmed that ≤2/6 subjects have DLE after administration of the study drug through unblinding by the independent safety evaluation team, the next dose level can be initiated; if >2/6 subjects have DLE, the dose escalation will be terminated. The previous dose before that dose will be regarded as the maximum tolerated dose (MTD). When the dose for single dose is escalated to the preset maximum dose, and no safety endpoint is observed, it can be considered to continue to explore higher dose after joint decision by investigators and the sponsor.
- Being tested
- JS005 (recombinant humanized monoclonal antibody against IL-17A), placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS005 (recombinant humanized monoclonal antibody against IL-17A)Biological
JS005
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| JS005 | Experimental | Not described Receives: Biological: JS005 (recombinant humanized monoclonal antibody against IL-17A) |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinically Significant Events .
Clinically significant events were defined as abnormal laboratory values and/or adverse events that are related to treatment.
Measured: From baseline through 12 weeks.
Secondary outcomes (10)
Pharmacokinetics (PK) of JS005.
Time to Reach the Maximum Concentration After Drug Administration (Tmax) in JS005 group.
Measured: From baseline through 12 weeks.
Pharmacokinetics (PK) of JS005.
Observed Maximum Serum Concentration Following Drug Administration (Cmax) in JS005 group.
Measured: From baseline through 12 weeks.
Pharmacokinetics (PK) of JS005.
Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast) in JS005 group.
Measured: From baseline through 12 weeks.
Pharmacokinetics (PK) of JS005.
Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf) in JS005 group.
Measured: From baseline through 12 weeks.
Pharmacokinetics (PK) of JS005.
Mean residence time (MRT) in JS005 group.
Measured: From baseline through 12 weeks.
Pharmacokinetics (PK) of JS005.
Systemic Clearance From Serum Following Intravenous Administration (CL) in JS005 group.
Measured: From baseline through 12 weeks.
Pharmacokinetics (PK) of JS005.
Terminal Elimination Half-life (T1/2) in JS005 group
Measured: From baseline through 12 weeks.
Pharmacokinetics (PK) of JS005.
Apparent terminal elimination rate constant in JS005 group.
Measured: From baseline through 12 weeks.
Pharmacokinetics (PK) of JS005.
Apparent volume of distribution (Vd) in JS005 group.
Measured: From baseline through 12 weeks.
Percentage of Participants With Anti-JS005 Antibodies.
Percentage of participants with treatment-emergent positive anti-JS005 antibodies was summarized by treatment group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-JS005 antibodies / number of evaluable participants * 100%.
Measured: From baseline through 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start17 May 2020
- Primary completion20 Nov 2020
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tolerability, Safety, Immunogenicity and Pharmacokinetic of JS005Studies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220073
- Sponsor's protocol ID
- JS005-001
- Status last verified
- Aug 2026
- First submitted
- 3 Jan 2020
- Last updated
- 13 Aug 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 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Tolerability, Safety, Immunogenicity and Pharmacokinetic Profile of Single Dose of JS005 (Recombinant Humanized Monoclonal Antibody Against IL-17A) Injection in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04220073
- Acronym / sponsor ID
- JS005-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 17 May 2020 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 7 Jan 2020 (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.
JS005-001 is one randomized, double-blind, placebo-controlled study to evaluate the tolerability, safety, immunogenicity and pharmacokinetic profile of single dose of JS005 injection in healthy volunteers.
A total of 5 dose groups are set in the study, i.e., 15 mg, 60 mg, 150 mg, 300 mg and 600 mg, single dose will be given subcutaneously in abdomen.
A total of 40 subjects are planned to be enrolled, 8 subjects will be enrolled in each group. Each dose group will be given the study drug and placebo at a ratio of 3:1. Each subject can only receive one single dose at one dose level.
Sentinel method will be used for dose escalation, and one independent safety evaluation team (SET) will be set up. 2 subjects (one receiving study drug, the other receiving placebo) will be randomized preferably and followed up until 3 days after administration when the dose starts in each dose group, the remaining 6 subjects (5 receiving study drug, 1 receiving placebo) can continue to be randomized after confirmation with the sponsor, if no any dose-limiting event (DLE) is observed during that period. Only when all the subjects at present dose level complete the follow-up for at least 14 days after administration, and no dose-limiting event (DLE) is observed in any one subject, the next dose level can be initiated after confirmation with the independent safety evaluation team and the sponsor, otherwise they must be observed for the full term of follow-up (i.e., on Day 85). If DLE is observed throughout the observational period, it is confirmed that ≤2/6 subjects have DLE after administration of the study drug through unblinding by the independent safety evaluation team, the next dose level can be initiated; if >2/6 subjects have DLE, the dose escalation will be terminated. The previous dose before that dose will be regarded as the maximum tolerated dose (MTD). When the dose for single dose is escalated to the preset maximum dose, and no safety endpoint is observed, it can be considered to continue to explore higher dose after joint decision by investigators and the sponsor.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JS005 | Experimental | Biological: JS005 (recombinant humanized monoclonal antibody against IL-17A) |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Signature of the informed consent form prior to the study, sufficient understanding of the content, course and possible adverse reactions of the study;
- Being able to complete the study according to the requirements in the study protocol;
- No plan of pregnancy and being willing to use effective contraceptive measures for subject (including partner) from 2 weeks prior to administration to 6 months after the last dose of study drug, see Appendix 5 for the specific contraceptive measures;
- Male and female subjects aged 18 to 45 years, inclusive;
- The body weight no less than 50 kg for male subjects and no less than 45 kg for female subjects. Body mass index (BMI) = weight (kg)/square of height, ranging from 18-26kg/m2 (including the critical value);
Key exclusion criteria (23 listed)
- Previous use of biopharmaceutical treatment directly targeting IL-17 monoclonal antibody or of IL-17 receptor (e.g., Secukinumab or Ixekizumab) at any time;
- Use of therapeutic biological preparations within 12 weeks prior to administration (on Day 1), or remaining in the elimination period of the drug (within 5 half-lives) at randomization;
- Participation in any other clinical study with intervention of investigational product within 12 weeks prior to randomization (on Day 1), or remaining in the elimination period of the drug (within 5 half-lives) at randomization;
- Vaccination of Bacille Calmette-Guérin vaccine within 12 months prior to administration (on Day 1), or vaccination of other live vaccine within 12 weeks, or plan to use Bacille Calmette-Guérin vaccine or other live vaccine during the study and within 12 weeks after the study;
- Any infection requiring hospitalization, antiviral or antibiotic therapy (e.g., pneumonia, cellulitis, bone and joint infection, etc., the subject is judged by investigators to have weakened immune system and may have unacceptable risk if participating in this study) within 30 days prior to administration (on Day 1);
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 |
|---|---|---|
| JS005 (recombinant humanized monoclonal antibody against IL-17A)JS005 | Biological | JS005 |
| placeboplacebo | Drug | placebo |
Primary outcome
Number of Participants With Clinically Significant Events .
Time frame: From baseline through 12 weeks.
Clinically significant events were defined as abnormal laboratory values and/or adverse events that are related to treatment.
10 secondary outcomes
Pharmacokinetics (PK) of JS005.
Time frame: From baseline through 12 weeks.
Pharmacokinetics (PK) of JS005.
Time frame: From baseline through 12 weeks.
Pharmacokinetics (PK) of JS005.
Time frame: From baseline through 12 weeks.
Pharmacokinetics (PK) of JS005.
Time frame: From baseline through 12 weeks.
Pharmacokinetics (PK) of JS005.
Time frame: From baseline through 12 weeks.
Pharmacokinetics (PK) of JS005.
Time frame: From baseline through 12 weeks.
Pharmacokinetics (PK) of JS005.
Time frame: From baseline through 12 weeks.
Pharmacokinetics (PK) of JS005.
Time frame: From baseline through 12 weeks.
Pharmacokinetics (PK) of JS005.
Time frame: From baseline through 12 weeks.
Percentage of Participants With Anti-JS005 Antibodies.
Time frame: From baseline through 24 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 13 Aug 2026.
- Individual participant dataSharing planned: No
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 testing JS005 (recombinant humanized monoclonal antibody against IL-17A) in people with Tolerability, Safety, Immunogenicity and Pharmacokinetic of JS005, run by Shanghai Junshi Bioscience 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 7 inclusion and 23 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 13 Aug 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?
Number of Participants With Clinically Significant Events . (time frame: From baseline through 12 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 13 Aug 2026; AzTrials last refreshed its copy on 29 Oct 2026.