Healthy VolunteerPhase 1NCT02521610
A Multiple Ascending-Dose Study of RG7625 in Healthy Volunteers
A Phase 1 study testing RG7625 in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in Netherlands.
Trial summary
This randomized, double-blind, placebo-controlled, ascending-dose, parallel-group study will evaluate the pharmacodynamic effects, pharmacokinetics, safety, and tolerability of one week of RG7625 dosing in healthy male and female volunteers. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- RG7625
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2015to Nov 2015
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult males and females 18 to 60 years of age, inclusive
- Body mass index 18.0 to 30.0 kilograms per meter-squared (kg/m^2), inclusive
Who cannot join
- Any clinically relevant abnormalities, concomitant diseases or ongoing medical conditions, abnormal laboratory test results, or a history of any other clinically significant disorders
- Any major illness within the one month preceding the Screening visit, or any febrile illness within the two weeks preceding the Screening visit
- Any significant allergic reaction to drugs
- Immunocompromised or with reduced immune function and/or immunization within 30 days before the first study drug administration or planning vaccination during the study
- Women who are pregnant or lactating or of childbearing potential
- Clinically significant abnormal electrocardiogram (ECG) or other risk factors for QT prolongation
- Use of prescribed or over-the-counter medication
- Inability or unwillingness to comply with study requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose Study to Investigate the Pharmacokinetics, Pharmacodynamic Effects, Safety and Tolerability of Repeated Dosing of RO5459072 in Healthy Subjects
This randomized, double-blind, placebo-controlled, ascending-dose, parallel-group study will evaluate the pharmacodynamic effects, pharmacokinetics, safety, and tolerability of one week of RG7625 dosing in healthy male and female volunteers. Each participant will receive a single dose of RG7625 or placebo followed by one week of dosing with the same treatment. Each participant will also receive intradermal administration of 4 recall antigens at Screening and on Day 7 of treatment to assess study drug effects on delayed-type hypersensitivity (DTH).
- Conditions
- Healthy Volunteer
- Being tested
- Placebo, RG7625
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Participants will receive the placebo equivalent to RG7625 once or twice daily for 8 days. The first dose will be administered on Day 1 and the regimen will be continued during Days 3 to 9, with only a single dose given on Day 9.
RG7625Drug
Participants will receive RG7625 as oral capsules once or twice daily for 8 days. The first dose will be administered on Day 1 and the regimen will be continued during Days 3 to 9, with only a single dose given on Day 9.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Healthy volunteers will receive the placebo equivalent to RG7625 as oral capsules once or twice daily for 8 days. Each cohort will receive intradermal administration of 4 antigens (tetanus toxoid, tuberculin purified protein derivative [PPD], Candida albicans, and Trichophyton species) and a negative control at Screening and on Day 7 of treatment to assess for DTH. Receives: Drug: Placebo |
| RG7625 | Experimental | Participants will undergo a series of Screening visits prior to treatment and 7- to 14-day follow-up. Healthy volunteers will be enrolled in up to 4 cohorts and will receive RG7625 as oral capsules once or twice daily for 8 days. The first cohort is planned to receive 100 milligrams (mg) on Day 1, followed by 100 mg twice daily on Days 3 to 9. Subsequent dose and frequency decisions will be based upon observations in previous cohort(s). Each cohort will receive intradermal administration of 4 antigens (tetanus toxoid, tuberculin PPD, Candida albicans, and Trichophyton species) and a negative control at Screening and on Day 7 of treatment to assess for DTH. Receives: Drug: RG7625 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in concentration of 10-kilodalton (kDa) cluster of differentiation (CD) 74 intermediate (p10) in B-cells
Measured: From Baseline (Day 1) to 24 hours after the Day 9 dose
Secondary outcomes (5)
Incidence of adverse events
Measured: Up to 9 weeks
Change in size of induration from DTH response
Measured: Up to 7 weeks
Area under the concentration-time curve (AUC) of RG7625
Measured: Pre-dose at Baseline (Day 1) to 24 hours after the Day 9 dose
Maximum observed concentration (Cmax) of RG7625
Measured: Pre-dose at Baseline (Day 1) to 24 hours after the Day 9 dose
Time to maximum observed concentration (Tmax) of RG7625
Measured: Pre-dose at Baseline (Day 1) to 24 hours after the Day 9 dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521610
- Sponsor's protocol ID
- BP29772
- Status last verified
- Nov 2016
- First submitted
- 10 Aug 2015
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose Study to Investigate the Pharmacokinetics, Pharmacodynamic Effects, Safety and Tolerability of Repeated Dosing of RO5459072 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02521610
- Acronym / sponsor ID
- BP29772
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 13 Aug 2015 (estimated)
- 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 randomized, double-blind, placebo-controlled, ascending-dose, parallel-group study will evaluate the pharmacodynamic effects, pharmacokinetics, safety, and tolerability of one week of RG7625 dosing in healthy male and female volunteers. Each participant will receive a single dose of RG7625 or placebo followed by one week of dosing with the same treatment. Each participant will also receive intradermal administration of 4 recall antigens at Screening and on Day 7 of treatment to assess study drug effects on delayed-type hypersensitivity (DTH).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboHealthy volunteers will receive the placebo equivalent to RG7625 as oral capsules once or twice daily for 8 days. Each cohort will receive intradermal administration of 4 antigens (tetanus toxoid, tuberculin purified protein derivative [PPD], Candida albicans, and Trichophyton species) and a negative control at Screening and on Day 7 of treatment to assess for DTH. |
| RG7625 | Experimental | Drug: RG7625Participants will undergo a series of Screening visits prior to treatment and 7- to 14-day follow-up. Healthy volunteers will be enrolled in up to 4 cohorts and will receive RG7625 as oral capsules once or twice daily for 8 days. The first cohort is planned to receive 100 milligrams (mg) on Day 1, followed by 100 mg twice daily on Days 3 to 9. Subsequent dose and frequency decisions will be based upon observations in previous cohort(s). Each cohort will receive intradermal administration of 4 antigens (tetanus toxoid, tuberculin PPD, Candida albicans, and Trichophyton species) and a negative control at Screening and on Day 7 of treatment to assess for DTH. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adult males and females 18 to 60 years of age, inclusive
- Body mass index 18.0 to 30.0 kilograms per meter-squared (kg/m^2), inclusive
Key exclusion criteria (8 listed)
- Any clinically relevant abnormalities, concomitant diseases or ongoing medical conditions, abnormal laboratory test results, or a history of any other clinically significant disorders
- Any major illness within the one month preceding the Screening visit, or any febrile illness within the two weeks preceding the Screening visit
- Any significant allergic reaction to drugs
- Immunocompromised or with reduced immune function and/or immunization within 30 days before the first study drug administration or planning vaccination during the study
- Women who are pregnant or lactating or of childbearing potential
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 |
|---|---|---|
| PlaceboParticipants will receive the placebo equivalent to RG7625 once or twice daily for 8 days. The first dose will be administered on Day 1 and the regimen will be continued during Days 3 to 9, with only a single dose given on Day 9. | Drug | Placebo |
| RG7625Participants will receive RG7625 as oral capsules once or twice daily for 8 days. The first dose will be administered on Day 1 and the regimen will be continued during Days 3 to 9, with only a single dose given on Day 9. | Drug | RG7625 |
Primary outcome
Change in concentration of 10-kilodalton (kDa) cluster of differentiation (CD) 74 intermediate (p10) in B-cells
Time frame: From Baseline (Day 1) to 24 hours after the Day 9 dose
5 secondary outcomes
Incidence of adverse events
Time frame: Up to 9 weeks
Change in size of induration from DTH response
Time frame: Up to 7 weeks
Area under the concentration-time curve (AUC) of RG7625
Time frame: Pre-dose at Baseline (Day 1) to 24 hours after the Day 9 dose
Maximum observed concentration (Cmax) of RG7625
Time frame: Pre-dose at Baseline (Day 1) to 24 hours after the Day 9 dose
Time to maximum observed concentration (Tmax) of RG7625
Time frame: Pre-dose at Baseline (Day 1) to 24 hours after the Day 9 dose
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 2 Nov 2016.
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Screening Protocol
Pain
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.
Clinical Trials study director
Hoffmann-La Roche
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 RG7625 in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in Netherlands.
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 2 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 2 Nov 2016. 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 Netherlands. 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?
Change in concentration of 10-kilodalton (kDa) cluster of differentiation (CD) 74 intermediate (p10) in B-cells (time frame: From Baseline (Day 1) to 24 hours after the Day 9 dose). 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 2 Nov 2016.