HealthyPhase 1NCT03320707
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-54767414 (Daratumumab) in Healthy Participants
A Phase 1 study testing Daratumumab and rHuPH20 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and tolerability of daratumumab following a single subcutaneous (SC) administration in healthy participants and to determine whether premedication with corticosteroids is required to improve the tolerability of SC administration of daratumumab in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Daratumumab and rHuPH20
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2017to 27 Aug 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must have a body weight in the range of 50 to 100 kilogram (kg), inclusive, and have a body mass index (BMI) of 19 to 30 kilogram per meter square (kg/m^2), inclusive, at screening and Day -1
- Must be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and Day -1
- Must be otherwise healthy on the basis of clinical laboratory tests performed at screening and Day -1
- A woman must not be of childbearing potential
- Must be a non-smoker or tobacco user or 3 months prior to screening
Who cannot join
- Pregnant or breastfeeding while enrolled in this study or within 20 weeks after the dose of study treatment
- History of or currently has any clinically significant medical illness or medical disorders the investigator considers significant, including, but not limited to immune deficiency state, liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Has a history of malignancy before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered cured with minimal risk of recurrence
- Active acute or chronic infection (including chronic recurrent or invasive candidiasis) or diagnosed latent infection
- Has had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening and/or plan to receive a BCG vaccine within 12 months after the administration of study treatment
- Has experienced a recent single dermatomal herpes zoster eruption within the past 6 months
- Has a history of multi-dermatomal herpes zoster or central nervous system (CNS) zoster within the past 5 years
- Has received prescription medications within 14 days prior to study treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-54767414 (Daratumumab) in Healthy Participants
The purpose of this study is to assess the safety and tolerability of daratumumab following a single subcutaneous (SC) administration in healthy participants and to determine whether premedication with corticosteroids is required to improve the tolerability of SC administration of daratumumab in healthy participants.
- Conditions
- Healthy
- Being tested
- Daratumumab, Placebo, rHuPH20
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaratumumabDrug
Also called JNJ-54767414
Single SC dose of daratumumab will be administered in each of 8 dose cohorts.
PlaceboDrug
Placebo liquid will be administered as SC dose in each of first 7 dose cohorts.
rHuPH20Drug
Participants in Cohort 8 will receive single SC dose of rHuPH20 as a part of daratumumab formulation.
| Study group | Role | What they receive |
|---|---|---|
| Daratumumab | Experimental | Participants will receive a single subcutaneous (SC) dose of daratumumab in each of first 7 dose cohorts. Doses will be escalated based on review of pharmacokinetic, pharmacodynamic, and safety data of previous cohort. Participants in Cohort 8 will receive single SC daratumumab formulation containing recombinant human hyaluronidase (rHuPH20). Receives: Drug: Daratumumab; Drug: rHuPH20 |
| Placebo | Placebo comparator | Participants will receive placebo as a single SC dose in each of first 7 cohorts. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Treatment-Emergent Adverse Event (TEAEs) by Severity Through Day 141 Versus Placebo
The safety and tolerability of daratumumab following a single subcutaneous (SC) administration in healthy participants will be assessed.
Measured: Up to Day 141
Proportion of Participants With TEAEs by Serious Adverse Events (SAEs) Through Day 141 Versus Placebo
The safety and tolerability of daratumumab following a single subcutaneous (SC) administration in healthy participants will be assessed.
Measured: Up to Day 141
Secondary outcomes (7)
Maximum Observed Plasma Concentration (Cmax)
Cmax is the maximum observed plasma concentration.
Measured: Day 1 predose through Day 141
Time to the Maximum Observed Plasma Concentration (Tmax)
Tmax is defined as actual sampling time to reach maximum observed plasma concentration.
Measured: Day 1 predose through Day 141
Area Under the Plasma Concentration-time Curve From Time Zero to the Time Corresponding to the Last Quantifiable Serum Concentration (AUC [0-last])
AUC (0-last) is the area under the plasma concentration-time curve from time zero to the time corresponding to the last quantifiable serum concentration.
Measured: Day 1 predose through Day 141
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity With Extrapolation of the Terminal Phase (AUC[0- infinity])
AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinity with extrapolation of the terminal phase, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Measured: Day 1 predose through Day 141
Number of Participants With Anti-daratumumab Antibodies
Number of participants who test positive for anti-daratumumab antibodies will be reported.
Measured: Day 1 predose through Day 141
Number of Participants With Anti-recombinant Human Hyaluronidase (rHuPH20) Antibodies
Number of participants who test positive for anti-rHuPH20 antibodies will be reported.
Measured: Day 1 predose through Day 141
Percentage of CD38 Expression Levels and CD38 Expressing Cell Counts Measured by Flow Cytometry
The cluster of differentiation (CD) 38 expression levels and CD38 expressing cell counts, as measured by flow cytometry, will be summarized.
Measured: Day 1 predose through Day 141
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start16 Oct 2017
- Primary completion27 Aug 2019
- Study completion27 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320707
- Sponsor's protocol ID
- CR108356
- Other IDs
- 54767414EDI1001
- Status last verified
- Jan 2025
- First submitted
- 11 Oct 2017
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-54767414 (Daratumumab) in Healthy Participants
- ClinicalTrials.gov ID
- NCT03320707
- Acronym / sponsor ID
- CR108356
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 27 Aug 2019 (actual)
- Study completion
- 27 Aug 2019 (actual)
- First posted
- 25 Oct 2017 (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.
The purpose of this study is to assess the safety and tolerability of daratumumab following a single subcutaneous (SC) administration in healthy participants and to determine whether premedication with corticosteroids is required to improve the tolerability of SC administration of daratumumab in healthy participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daratumumab | Experimental | Drug: Daratumumab, Drug: rHuPH20Participants will receive a single subcutaneous (SC) dose of daratumumab in each of first 7 dose cohorts. Doses will be escalated based on review of pharmacokinetic, pharmacodynamic, and safety data of previous cohort. Participants in Cohort 8 will receive single SC daratumumab formulation containing recombinant human hyaluronidase (rHuPH20). |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo as a single SC dose in each of first 7 cohorts. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Must have a body weight in the range of 50 to 100 kilogram (kg), inclusive, and have a body mass index (BMI) of 19 to 30 kilogram per meter square (kg/m^2), inclusive, at screening and Day -1
- Must be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and Day -1
- Must be otherwise healthy on the basis of clinical laboratory tests performed at screening and Day -1
- A woman must not be of childbearing potential
- Must be a non-smoker or tobacco user or 3 months prior to screening
Key exclusion criteria (8 listed)
- Pregnant or breastfeeding while enrolled in this study or within 20 weeks after the dose of study treatment
- History of or currently has any clinically significant medical illness or medical disorders the investigator considers significant, including, but not limited to immune deficiency state, liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Has a history of malignancy before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered cured with minimal risk of recurrence
- Active acute or chronic infection (including chronic recurrent or invasive candidiasis) or diagnosed latent infection
- Has had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening and/or plan to receive a BCG vaccine within 12 months after the administration of study treatment
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 |
|---|---|---|
| DaratumumabAlso: JNJ-54767414Single SC dose of daratumumab will be administered in each of 8 dose cohorts. | Drug | Daratumumab |
| PlaceboPlacebo liquid will be administered as SC dose in each of first 7 dose cohorts. | Drug | Placebo |
| rHuPH20Participants in Cohort 8 will receive single SC dose of rHuPH20 as a part of daratumumab formulation. | Drug | Daratumumab |
Primary outcome
Proportion of Participants With Treatment-Emergent Adverse Event (TEAEs) by Severity Through Day 141 Versus Placebo
Time frame: Up to Day 141
The safety and tolerability of daratumumab following a single subcutaneous (SC) administration in healthy participants will be assessed.
Proportion of Participants With TEAEs by Serious Adverse Events (SAEs) Through Day 141 Versus Placebo
Time frame: Up to Day 141
The safety and tolerability of daratumumab following a single subcutaneous (SC) administration in healthy participants will be assessed.
7 secondary outcomes
Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 1 predose through Day 141
Time to the Maximum Observed Plasma Concentration (Tmax)
Time frame: Day 1 predose through Day 141
Area Under the Plasma Concentration-time Curve From Time Zero to the Time Corresponding to the Last Quantifiable Serum Concentration (AUC [0-last])
Time frame: Day 1 predose through Day 141
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity With Extrapolation of the Terminal Phase (AUC[0- infinity])
Time frame: Day 1 predose through Day 141
Number of Participants With Anti-daratumumab Antibodies
Time frame: Day 1 predose through Day 141
Number of Participants With Anti-recombinant Human Hyaluronidase (rHuPH20) Antibodies
Time frame: Day 1 predose through Day 141
Percentage of CD38 Expression Levels and CD38 Expressing Cell Counts Measured by Flow Cytometry
Time frame: Day 1 predose through Day 141
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 3 Feb 2025.
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
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 Daratumumab and rHuPH20 in people with Healthy, run by Janssen Research & Development, LLC 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 5 inclusion and 8 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 3 Feb 2025. 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?
Proportion of Participants With Treatment-Emergent Adverse Event (TEAEs) by Severity Through Day 141 Versus Placebo (time frame: Up to Day 141). 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 3 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.