Healthy Adult SubjectsPhase 1NCT03794180
Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Healthy Adult Subjects
A Phase 1 study testing TJ003234 in people with Healthy Adult Subjects, run by I-Mab Biopharma US Limited at 1 site in United States.
Trial summary
TJ003234RAR101 is a first-in-human (FIH), single-center, randomized, double-blind, placebo-controlled, single ascending dose study of TJ003234 in healthy adults to determine whether TJ003234 is safe and tolerated when administered as an intravenous (IV) infusion and to determine the maximum dose tolerated (MTD). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Subjects
- What is being tested?
- TJ003234
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2019to 5 Sep 2019
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to understand and willing to sign the informed consent form (ICF)
- Healthy subjects 18-70 years of age
- If of childbearing potential, agree to use protocol-specified contraception
- Body mass index (BMI) 19.0-32.0 kg/m^2
- Blood pressure ≤ 139/89 mm Hg
- Subjects are able to follow the study protocol and complete the trial
Who cannot join
- Current use of tobacco or nicotine-containing products or illicit drug use
- History of severe allergic or anaphylactic reaction to a therapeutic drug or severe seasonal allergies
- Any known pulmonary disease
- Use of any prescription, investigational drugs, herbal supplements, or nonprescription drugs within 1 month or 5 half-lives (whichever is longer) prior to study drug administration, or dietary supplements within 1 week prior to study drug administration, unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study
- Abnormal hematological and chemistry laboratory values >10% above upper limit of normal (ULN) or >10% below the lower limit of normal (LLN). Absolute neutrophil count (ANC) ≤ 1000 cells/mm^3
- Use of any biologic drugs in the last 120 days prior to dosing.
Show all 11Show fewer
- Immunization with a live or attenuated vaccine within 4 weeks prior to study drug administration
- Prior treatment with any biologic anti-GM-CSF or GM-CSF receptor antagonists
- ADA screening positive
- Subjects who have a history of documented autoimmune disease, even if not clinically severe or never treated with systemic steroids or immunosuppressive agents
- A positive alcohol test and/or urine drug screen for substance of abuse at screening or upon check-in to the clinical site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First-in-Human, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of TJ003234 (Anti-Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) Monoclonal Antibody) in Healthy Subjects
TJ003234RAR101 is a first-in-human (FIH), single-center, randomized, double-blind, placebo-controlled, single ascending dose study of TJ003234 in healthy adults to determine whether TJ003234 is safe and tolerated when administered as an intravenous (IV) infusion and to determine the maximum dose tolerated (MTD).
- Conditions
- Healthy Adult Subjects
- Being tested
- TJ003234, Placebo
- Keywords
- Anti-GM-CSF agents, GM-CSF/GM-CSFR (GM-CSF receptor) antibody, colony-stimulating factor 2, monoclonal antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TJ003234Drug
Brownish-yellow liquid containing TJ003234, a recombinant humanized immunoglobulin (Ig) G1 monoclonal antibody diluted with normal saline
PlaceboDrug
Colorless to slightly brownish-yellow liquid without TJ003234 diluted with normal saline
| Study group | Role | What they receive |
|---|---|---|
| TJ003234 | Experimental | 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg via single IV infusion Receives: Drug: TJ003234 |
| Placebo | Placebo comparator | 0 mg/kg via single IV infusion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Profile: AEs
Incidence of Adverse Events (AEs)
Measured: Up to 85 days after study drug administration
Maximum Tolerated Dose
Determine Maximum Tolerated Dose of TJ003234
Measured: Up to 85 days after study drug administration
Secondary outcomes (6)
Pharmacokinetic (PK) Parameters: Tmax
Time of peak concentration (Tmax)
Measured: Up to 85 days after study drug administration
Pharmacokinetic (PK) Parameters: Cmax
Maximal Concentration (Cmax)
Measured: Up to 85 days after study drug administration
Pharmacokinetic (PK) Parameters: T1/2
Investigational product (IP) half-life (T1/2)
Measured: Up to 85 days after study drug administration
Pharmacokinetic (PK) Parameters: CL
Investigational Product (IP) Clearance (CL)
Measured: Up to 85 days after study drug administration
Pharmacokinetic (PK) Parameters: AUC∞
Area under the curve from time zero extrapolated to infinity (AUC∞)
Measured: Up to 85 days after study drug administration
Anti-drug antibodies (ADA)
Incidence and concentration of anti-drug antibodies
Measured: Up to 85 days after study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start18 Mar 2019
- Primary completion5 Sep 2019
- Study completion5 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult SubjectsStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- I-Mab Biopharma US Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claire Xu, MD, PhD, Study director, I-Mab Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794180
- Sponsor's protocol ID
- TJ003234RAR101
- Status last verified
- Dec 2019
- First submitted
- 28 Dec 2018
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Human, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of TJ003234 (Anti-Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) Monoclonal Antibody) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03794180
- Acronym / sponsor ID
- TJ003234RAR101
- Conditions
- Healthy Adult Subjects
- Keywords
- Anti-GM-CSF agents, GM-CSF/GM-CSFR (GM-CSF receptor) antibody, colony-stimulating factor 2, monoclonal antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- I-Mab Biopharma US LimitedIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 5 Sep 2019 (actual)
- First posted
- 4 Jan 2019 (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.
TJ003234RAR101 is a first-in-human (FIH), single-center, randomized, double-blind, placebo-controlled, single ascending dose study of TJ003234 in healthy adults to determine whether TJ003234 is safe and tolerated when administered as an intravenous (IV) infusion and to determine the maximum dose tolerated (MTD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TJ003234 | Experimental | Drug: TJ0032340.3 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg via single IV infusion |
| Placebo | Placebo comparator | Drug: Placebo0 mg/kg via single IV infusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to understand and willing to sign the informed consent form (ICF)
- Healthy subjects 18-70 years of age
- If of childbearing potential, agree to use protocol-specified contraception
- Body mass index (BMI) 19.0-32.0 kg/m^2
- Blood pressure ≤ 139/89 mm Hg
Key exclusion criteria (11 listed)
- Current use of tobacco or nicotine-containing products or illicit drug use
- History of severe allergic or anaphylactic reaction to a therapeutic drug or severe seasonal allergies
- Any known pulmonary disease
- Use of any prescription, investigational drugs, herbal supplements, or nonprescription drugs within 1 month or 5 half-lives (whichever is longer) prior to study drug administration, or dietary supplements within 1 week prior to study drug administration, unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study
- Abnormal hematological and chemistry laboratory values >10% above upper limit of normal (ULN) or >10% below the lower limit of normal (LLN). Absolute neutrophil count (ANC) ≤ 1000 cells/mm^3
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 |
|---|---|---|
| TJ003234Brownish-yellow liquid containing TJ003234, a recombinant humanized immunoglobulin (Ig) G1 monoclonal antibody diluted with normal saline | Drug | TJ003234 |
| PlaceboColorless to slightly brownish-yellow liquid without TJ003234 diluted with normal saline | Drug | Placebo |
Primary outcome
Safety Profile: AEs
Time frame: Up to 85 days after study drug administration
Incidence of Adverse Events (AEs)
Maximum Tolerated Dose
Time frame: Up to 85 days after study drug administration
Determine Maximum Tolerated Dose of TJ003234
6 secondary outcomes
Pharmacokinetic (PK) Parameters: Tmax
Time frame: Up to 85 days after study drug administration
Pharmacokinetic (PK) Parameters: Cmax
Time frame: Up to 85 days after study drug administration
Pharmacokinetic (PK) Parameters: T1/2
Time frame: Up to 85 days after study drug administration
Pharmacokinetic (PK) Parameters: CL
Time frame: Up to 85 days after study drug administration
Pharmacokinetic (PK) Parameters: AUC∞
Time frame: Up to 85 days after study drug administration
Anti-drug antibodies (ADA)
Time frame: Up to 85 days after study drug administration
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 18 Dec 2019.
- Individual participant dataSharing planned: No
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Healthy Subjects
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.
Claire Xu, MD, PhD study director
I-Mab Biopharma
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 TJ003234 in people with Healthy Adult Subjects, run by I-Mab Biopharma US Limited at 1 site in United States.
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 6 inclusion and 11 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 18 Dec 2019. 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 United States. 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?
Safety Profile: AEs (time frame: Up to 85 days after study drug administration). The study lists 2 primary outcomes in all. 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 18 Dec 2019.