Atopic DermatitisPhase 1NCT03846466
Study of KHK 4323 in Healthy Volunteers and Subjects With Atopic Dermatitis
A Phase 1 study testing KHK4323 IV/S, KHK4323 SC/S and KHK4323 IV/M in people with Atopic Dermatitis, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial summary
Part 1: To investigate the safety and tolerability of intravenous (IV) or subcutaneous (SC) administration of a single dose of KHK4323 to Japanese or Caucasian healthy adult males in a double-blind, placebo-controlled study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- KHK4323 IV/S, KHK4323 SC/S and KHK4323 IV/M
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteJapan
- Study dates
- 22 Feb 2019to 11 Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part 1:
- Japanese or Caucasian male aged 20 to under 45 years old at the time consent was obtained
- BMI ≥ 18.5 to < 30.0 at time of screening tests
- Part 2:
- Men and women aged 18 years or older at the time of consent
- Patients with EASI ≥ 16 in pre-administration testing
Show all 23Show fewer
- Patients with IGA of "3: Moderate" or higher in pre-administration testing
- Patients with BSA ≥ 10% at screening in pre-administration testing
- "Exclusion Criteria:
- Part 1:
- Persons with existing respiratory disease, heart disease, gastrointestinal disease, kidney disease, or liver disease
- Persons confirmed to have a bacterial, viral, fungal, or parasitic infection within 28 days prior to obtainment of consent
- Persons who have contracted an infectious disease requiring hospitalization or IV administration of an antibiotic within 6 months prior to obtainment of consent
- Persons who have been treated with a biological preparation (antibody, etc.) or have been administered an investigational drug within 6 months prior to the obtainment of consent
- Persons who have used a medication (including over-the-counter drugs, topical agents, vitamins, and herbal medicines) within 2 weeks prior to obtainment of consent (for an immunosuppressant drug, within 60 days)
- Persons who routinely smoke an average of more than 10 cigarettes a day (to be confirmed in interview at time of screening tests) or cannot follow the rules regarding smoking during the clinical trial period
- Part 2:
- Patients with severe complications judged to affect the implementation and evaluation of the study in the opinion of the investigator or sub-investigator. Includes but is not limited to the following. Severe cardiovascular disease (e.g., class III or IV according to New York Heart Association functional classification), poorly controlled diabetes mellitus (HbA1c > 8.5%), poorly controlled hypertension, liver disease with severity of moderate or higher (e.g., class B or C according to Child-Pugh classification), kidney disease, respiratory disease, gastrointestinal disease, blood dyscrasia, central nervous system disease, psychiatric disease, autoimmune disease, etc.
- Patients observed to have one of the following laboratory test abnormalities in screening tests
- Neutrophil count: < 1500/μL
- Serum creatinine: > 1.5 mg/dL
- AST or ALT: > 2.5-fold the upper limit of the reference range
- Other laboratory test abnormalities that the investigator or sub-investigator thinks could affect the completion or evaluation of the clinical trial
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single Dose or Multiple Dose Study of KHK4323 in Healthy Volunteers, and Subjects With Atopic Dermatitis
Part 1: To investigate the safety and tolerability of intravenous (IV) or subcutaneous (SC) administration of a single dose of KHK4323 to Japanese or Caucasian healthy adult males in a double-blind, placebo-controlled study.
Part 2: To investigate the safety and tolerability of intravenous (IV) administration of repeated doses of KHK4323 to atopic dermatitis patients in a double-blind, placebo-controlled study.
- Conditions
- Atopic Dermatitis
- Being tested
- KHK4323 IV/S, KHK4323 SC/S, KHK4323 IV/M, Placebo IV/S, Placebo IV/M
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KHK4323 IV/SDrug
IV / Single administration
KHK4323 SC/SDrug
SC / Single administration
KHK4323 IV/MDrug
IV / Multiple administration
Placebo IV/SDrug
IV / Single administration
Placebo IV/MDrug
IV / Multiple administration
Placebo SC/SDrug
SC / Single administration
| Study group | Role | What they receive |
|---|---|---|
| Part1 Dose 1A | Experimental | Single administration Receives: Drug: KHK4323 IV/S |
| Part1 Dose 1P | Placebo comparator | Single administration Receives: Drug: Placebo IV/S |
| Part1 Dose 2A | Experimental | Single administration Receives: Drug: KHK4323 IV/S |
| Part1 Dose 2P | Placebo comparator | Single administration Receives: Drug: Placebo IV/S |
| Part1 Dose 3A | Experimental | Single administration Receives: Drug: KHK4323 IV/S |
| Part1 Dose 3P | Placebo comparator | Single administration Receives: Drug: Placebo IV/S |
| Part1 Dose 4A | Experimental | Single administration Receives: Drug: KHK4323 IV/S |
| Part1 Dose 4P | Placebo comparator | Single administration Receives: Drug: Placebo IV/S |
| Part1 Dose 5A | Experimental | Single administration Receives: Drug: KHK4323 SC/S |
| Part1 Dose 5P | Placebo comparator | Single administration Receives: Drug: Placebo SC/S |
| Part1 Dose 6A | Experimental | Single administration Receives: Drug: KHK4323 IV/S |
| Part1 Dose 6P | Placebo comparator | Single administration Receives: Drug: Placebo IV/S |
| Part1 Dose 7A | Experimental | Single administration Receives: Drug: KHK4323 IV/S |
| Part1 Dose 7P | Placebo comparator | Single administration Receives: Drug: Placebo IV/S |
| Part2 Dose 1A | Experimental | Multiple administration Receives: Drug: KHK4323 IV/M |
| Part2 Dose 1P | Placebo comparator | Multiple administration Receives: Drug: Placebo IV/M |
| Part2 Dose 2A | Experimental | Multiple administration Receives: Drug: KHK4323 IV/M |
| Part2 Dose 2P | Placebo comparator | Multiple administration Receives: Drug: Placebo IV/M |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
For adverse events that occurred after administration of the investigational drug, number of subjects with AEs and occurrence frequency are classified by MedDRA PT and SOC and shown according to dose group.
Measured: Part 1: from Day 1 through at most Day 169, Part 2: from Day 1 through at most Day 225
Secondary outcomes (2)
Profile of pharmacokinetics of serum KHK4323 concentration in Part 1
Anti-KHK4323 antibodies
Measured: Day 1 (pre-dose, 1, 6 hours after the start of administration) Day 2, Day 3, Day 4, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141, Day 169
Profile of pharmacokinetics of serum KHK4323 concentration in Part 2
Anti-KHK4323 antibodies
Measured: Day 1( pre-dose, 1 hours after the start of administration), Day 8, Day 15, Day 29,Day 43, Day 57, Day 85, Day 113, Day 169, Day 225
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start22 Feb 2019
- Primary completion11 Dec 2019
- Study completion11 Dec 2019
Why it stopped: The study terminated for safety reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Kyowa Kirin Co., Ltd.The 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846466
- Sponsor's protocol ID
- 4323-001
- Status last verified
- Jan 2020
- First submitted
- 17 Feb 2019
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single Dose or Multiple Dose Study of KHK4323 in Healthy Volunteers, and Subjects With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03846466
- Acronym / sponsor ID
- 4323-001
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study terminated for safety reasons.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Feb 2019 (actual)
- Primary completion
- 11 Dec 2019 (actual)
- Study completion
- 11 Dec 2019 (actual)
- First posted
- 19 Feb 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.
Part 1: To investigate the safety and tolerability of intravenous (IV) or subcutaneous (SC) administration of a single dose of KHK4323 to Japanese or Caucasian healthy adult males in a double-blind, placebo-controlled study.
Part 2: To investigate the safety and tolerability of intravenous (IV) administration of repeated doses of KHK4323 to atopic dermatitis patients in a double-blind, placebo-controlled study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 18
| Arm | Type | Receives |
|---|---|---|
| Part1 Dose 1A | Experimental | Drug: KHK4323 IV/SSingle administration |
| Part1 Dose 1P | Placebo comparator | Drug: Placebo IV/SSingle administration |
| Part1 Dose 2A | Experimental | Drug: KHK4323 IV/SSingle administration |
| Part1 Dose 2P | Placebo comparator | Drug: Placebo IV/SSingle administration |
| Part1 Dose 3A | Experimental | Drug: KHK4323 IV/SSingle administration |
| Part1 Dose 3P | Placebo comparator | Drug: Placebo IV/SSingle administration |
| Part1 Dose 4A | Experimental | Drug: KHK4323 IV/SSingle administration |
| Part1 Dose 4P | Placebo comparator | Drug: Placebo IV/SSingle administration |
| Part1 Dose 5A | Experimental | Drug: KHK4323 SC/SSingle administration |
| Part1 Dose 5P | Placebo comparator | Drug: Placebo SC/SSingle administration |
| Part1 Dose 6A | Experimental | Drug: KHK4323 IV/SSingle administration |
| Part1 Dose 6P | Placebo comparator | Drug: Placebo IV/SSingle administration |
| Part1 Dose 7A | Experimental | Drug: KHK4323 IV/SSingle administration |
| Part1 Dose 7P | Placebo comparator | Drug: Placebo IV/SSingle administration |
| Part2 Dose 1A | Experimental | Drug: KHK4323 IV/MMultiple administration |
| Part2 Dose 1P | Placebo comparator | Drug: Placebo IV/MMultiple administration |
| Part2 Dose 2A | Experimental | Drug: KHK4323 IV/MMultiple administration |
| Part2 Dose 2P | Placebo comparator | Drug: Placebo IV/MMultiple administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Japanese or Caucasian male aged 20 to under 45 years old at the time consent was obtained
- BMI ≥ 18.5 to < 30.0 at time of screening tests
- Men and women aged 18 years or older at the time of consent
- Patients with EASI ≥ 16 in pre-administration testing
- Patients with IGA of "3: Moderate" or higher in pre-administration testing
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| KHK4323 IV/SIV / Single administration | Drug | Part1 Dose 1A, Part1 Dose 2A, Part1 Dose 3A, Part1 Dose 4A, Part1 Dose 6A, Part1 Dose 7A |
| KHK4323 SC/SSC / Single administration | Drug | Part1 Dose 5A |
| KHK4323 IV/MIV / Multiple administration | Drug | Part2 Dose 1A, Part2 Dose 2A |
| Placebo IV/SIV / Single administration | Drug | Part1 Dose 1P, Part1 Dose 2P, Part1 Dose 3P, Part1 Dose 4P, Part1 Dose 6P, Part1 Dose 7P |
| Placebo IV/MIV / Multiple administration | Drug | Part2 Dose 1P, Part2 Dose 2P |
| Placebo SC/SSC / Single administration | Drug | Part1 Dose 5P |
Primary outcome
Number of participants with adverse events
Time frame: Part 1: from Day 1 through at most Day 169, Part 2: from Day 1 through at most Day 225
For adverse events that occurred after administration of the investigational drug, number of subjects with AEs and occurrence frequency are classified by MedDRA PT and SOC and shown according to dose group.
2 secondary outcomes
Profile of pharmacokinetics of serum KHK4323 concentration in Part 1
Time frame: Day 1 (pre-dose, 1, 6 hours after the start of administration) Day 2, Day 3, Day 4, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141, Day 169
Profile of pharmacokinetics of serum KHK4323 concentration in Part 2
Time frame: Day 1( pre-dose, 1 hours after the start of administration), Day 8, Day 15, Day 29,Day 43, Day 57, Day 85, Day 113, Day 169, Day 225
Results and safety
The study was stopped early (reason given: The study terminated for safety reasons.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
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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 testing KHK4323 IV/S, KHK4323 SC/S and KHK4323 IV/M in people with Atopic Dermatitis, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
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 23 inclusion and 0 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: stopped early, as of the sponsor's last update on 28 Jan 2020. 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 Japan. 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 was stopped early (reason given: The study terminated for safety reasons.). Results are not available in the source record.
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 adverse events (time frame: Part 1: from Day 1 through at most Day 169, Part 2: from Day 1 through at most Day 225). 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 28 Jan 2020.