HealthyPhase 1NCT03579030
Safety and PK/PD of RTA 1701 in Healthy Adults
A Phase 1 study testing RTA 1701 capsules in people with Healthy, run by Biogen at 1 site in Australia.
Trial summary
This first-in-human, Phase 1, single-center study will evaluate single ascending doses (SAD) and multiple ascending doses (MAD) of RTA 1701 conducted in 2 parts. Part 1 (SAD) of this study will be conducted in approximately 56 healthy participants in up to 7 groups. 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?
- RTA 1701 capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteAustralia
- Study dates
- 20 Jun 2018to 28 Jun 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
- Male or female and age is between 18 and 55 years, inclusive;
- Female participants of childbearing potential must:
- Not be pregnant, or lactating, or planning a pregnancy, and
- Be willing to use contraception (hormonal contraceptives, diaphragm, or intrauterine contraception) or abstain from sexual activity (if this is the preferred lifestyle for the participant) for the duration of the study (from initial study drug administration through 90 days after administration of the last dose of study drug);
- Females must have negative results for pregnancy tests performed:
- At screening based on a serum sample, and
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- Prior to dosing on Day -1 based on a urine sample;
- If male, participant must be surgically sterile or practice specified methods of contraception from initial study drug administration through 90 days after administration of the last dose of study drug. Male participants must also use a condom during sex to protect male or female partners of male participants from exposure to study drug. In addition to use of a condom, male participants with female partners must also use one of the following acceptable forms of contraception:
- Have had a vasectomy (at least 6 months earlier);
- Partner use of hormonal contraceptives (oral, parenteral, vaginal, or transdermal) for at least 3 months prior to study drug administration;
- Partner use of an intrauterine device;
- Complete abstinence from sexual intercourse (if this is the preferred lifestyle for the participant);
- If male, participant agrees to abstain from sperm donation from initial study drug administration through 90 days after administration of the last dose of study drug;
- Body Mass Index (BMI) is ≥ 18.0 to ≤ 31.0 kg/m2, inclusive;
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG), as judged by the investigator;
- Must voluntarily sign and date each informed consent, approved by a Human Research Ethics Committee (HREC), prior to the initiation of any screening or study-specific procedures.
Who cannot join
- History of clinically significant drug allergies, including allergies to any of the components of the investigational product and/or clinically significant food allergies as determined by the investigator;
- Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease, as determined by the investigator;
- Presence of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines;
- Requirement for any over-the-counter and/or prescription medication, vitamins, and/or herbal supplements on an ongoing basis;
- Use of any OTC medications (over-the-counter), including herbal products, within 7 days prior to Day 1, other than limited paracetamol use (≤ 2 g/day) or oral contraceptive pill. Use of any prescription medication within 14 days or 5 half-lives (whichever is longer), prior to study drug administration, unless in the opinion of the Principal Investigator and/or Medical Monitor the medication will not compromise participant safety or interfere with study procedures or data validity;
- Recent (6-month) history of drug or alcohol abuse;
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- Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or HIV antibodies (HIV Ab) at screening;
- Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration;
- Receipt of any investigational product within a time period equal to 10 half-lives of the product, if known, or a minimum of 30 days prior to study drug administration;
- Positive screen results for drugs of abuse, alcohol, or cotinine at screening or Day -1;
- Consumption of alcohol within 72 hours prior to study drug administration;
- Consumption of grapefruit, grapefruit products, star fruit, star fruit products, or Seville oranges within the 72-hour period prior to study drug administration;
- Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration;
- Current enrollment in another clinical study;
- Screening laboratory analyses that show any of the following abnormal laboratory results:
- Alanine transaminase (ALT) level above 1.5 times the upper limit of normal (ULN);
- Aspartate transaminase (AST) level above 1.5 times the ULN;
- Any other laboratory results that are outside of the laboratory normal reference range and considered clinically significant by the investigator;
- Clinically-significant abnormal ECG; ECG with QTc using Fridericia's correction formula (QTcF) > 450 msec (for males) or >460 msec (for females) is exclusionary;
- Consideration by the investigator, for any reason, that the participant is an unsuitable candidate to receive RTA 1701.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of RTA 1701 in Healthy Adults
This first-in-human, Phase 1, single-center study will evaluate single ascending doses (SAD) and multiple ascending doses (MAD) of RTA 1701 conducted in 2 parts. Part 1 (SAD) of this study will be conducted in approximately 56 healthy participants in up to 7 groups. Each group will consist of up to 8 participants who will be randomized in a 3:1 ratio to receive a single dose of RTA 1701 or placebo, respectively. Safety, tolerability, and available pharmacokinetics in each group will be assessed by the Safety Monitoring Committee prior to dose escalation.
Part 2 (MAD) of this study will be conducted in approximately 30 healthy participants in up to 3 groups and will commence after safety data for the highest dose in the SAD phase has been evaluated. Each group will consist of up to 10 participants who will be randomized in a 4:1 ratio to receive 14 daily doses of RTA 1701 or placebo, respectively. Safety, tolerability, and available pharmacokinetics will be assessed in each dosing group prior to dose escalation
- Conditions
- Healthy
- Being tested
- Placebo oral capsule, RTA 1701 capsules
- Keywords
- RTA 1701, RTA 1701 capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo oral capsuleDrug
Placebo capsule matched to an RTA 1701 capsule
RTA 1701 capsulesDrug
Capsule containing RTA 1701, multiple dosages
| Study group | Role | What they receive |
|---|---|---|
| Single Dose of RTA 1701 or Placebo | Experimental | RTA 1701 capsules or placebo taken orally in a single dose.
Group 1: RTA 1701 10 mg or matching placebo Group 2: RTA 1701 ≤ 20 mg or matching placebo Group 3: RTA 1701 ≤ 40 mg or matching placebo Group 4: RTA 1701 ≤ 80 mg or matching placebo Group 5: RTA 1701 ≤ 160 mg or matching placebo Group 6: RTA 1701 ≤ 320 mg or matching placebo Group 7: RTA 1701 ≤ 640 mg or matching placebo Receives: Drug: Placebo oral capsule; Drug: RTA 1701 capsules |
| Multiple Dose of RTA 1701 or Placebo | Experimental | RTA 1701 capsules, Dose TBD mg or placebo taken orally once daily for 14 weeks.
Group 8: RTA 1701 ≤40 mg or matching placebo Group 9: RTA 1701 ≤160 mg or matching placebo Group 10: RTA 1701 ≤640 mg or matching placebo Receives: Drug: Placebo oral capsule; Drug: RTA 1701 capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events
Safety will be assessed based on the number of treatment-emergent adverse events
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start20 Jun 2018
- Primary completion28 Jun 2019
- Study completion28 Jun 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 BiogenThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579030
- Sponsor's protocol ID
- 1701-C-1802
- Status last verified
- May 2025
- First submitted
- 25 May 2018
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of RTA 1701 in Healthy Adults
- ClinicalTrials.gov ID
- NCT03579030
- Acronym / sponsor ID
- 1701-C-1802
- Conditions
- Healthy
- Keywords
- RTA 1701, RTA 1701 capsules
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 6 Jul 2018 (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.
This first-in-human, Phase 1, single-center study will evaluate single ascending doses (SAD) and multiple ascending doses (MAD) of RTA 1701 conducted in 2 parts. Part 1 (SAD) of this study will be conducted in approximately 56 healthy participants in up to 7 groups. Each group will consist of up to 8 participants who will be randomized in a 3:1 ratio to receive a single dose of RTA 1701 or placebo, respectively. Safety, tolerability, and available pharmacokinetics in each group will be assessed by the Safety Monitoring Committee prior to dose escalation.
Part 2 (MAD) of this study will be conducted in approximately 30 healthy participants in up to 3 groups and will commence after safety data for the highest dose in the SAD phase has been evaluated. Each group will consist of up to 10 participants who will be randomized in a 4:1 ratio to receive 14 daily doses of RTA 1701 or placebo, respectively. Safety, tolerability, and available pharmacokinetics will be assessed in each dosing group prior to dose escalation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Dose of RTA 1701 or Placebo | Experimental | Drug: Placebo oral capsule, Drug: RTA 1701 capsulesRTA 1701 capsules or placebo taken orally in a single dose. Group 1: RTA 1701 10 mg or matching placebo Group 2: RTA 1701 ≤ 20 mg or matching placebo Group 3: RTA 1701 ≤ 40 mg or matching placebo Group 4: RTA 1701 ≤ 80 mg or matching placebo Group 5: RTA 1701 ≤ 160 mg or matching placebo Group 6: RTA 1701 ≤ 320 mg or matching placebo Group 7: RTA 1701 ≤ 640 mg or matching placebo |
| Multiple Dose of RTA 1701 or Placebo | Experimental | Drug: Placebo oral capsule, Drug: RTA 1701 capsulesRTA 1701 capsules, Dose TBD mg or placebo taken orally once daily for 14 weeks. Group 8: RTA 1701 ≤40 mg or matching placebo Group 9: RTA 1701 ≤160 mg or matching placebo Group 10: RTA 1701 ≤640 mg or matching placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Male or female and age is between 18 and 55 years, inclusive;
- Female participants of childbearing potential must:
- Not be pregnant, or lactating, or planning a pregnancy, and
- Be willing to use contraception (hormonal contraceptives, diaphragm, or intrauterine contraception) or abstain from sexual activity (if this is the preferred lifestyle for the participant) for the duration of the study (from initial study drug administration through 90 days after administration of the last dose of study drug);
- Females must have negative results for pregnancy tests performed:
Key exclusion criteria (20 listed)
- History of clinically significant drug allergies, including allergies to any of the components of the investigational product and/or clinically significant food allergies as determined by the investigator;
- Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease, as determined by the investigator;
- Presence of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines;
- Requirement for any over-the-counter and/or prescription medication, vitamins, and/or herbal supplements on an ongoing basis;
- Use of any OTC medications (over-the-counter), including herbal products, within 7 days prior to Day 1, other than limited paracetamol use (≤ 2 g/day) or oral contraceptive pill. Use of any prescription medication within 14 days or 5 half-lives (whichever is longer), prior to study drug administration, unless in the opinion of the Principal Investigator and/or Medical Monitor the medication will not compromise participant safety or interfere with study procedures or data validity;
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 |
|---|---|---|
| Placebo oral capsulePlacebo capsule matched to an RTA 1701 capsule | Drug | Multiple Dose of RTA 1701 or Placebo, Single Dose of RTA 1701 or Placebo |
| RTA 1701 capsulesCapsule containing RTA 1701, multiple dosages | Drug | Multiple Dose of RTA 1701 or Placebo, Single Dose of RTA 1701 or Placebo |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: 3 weeks
Safety will be assessed based on the number of treatment-emergent adverse events
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 29 May 2025.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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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 RTA 1701 capsules in people with Healthy, run by Biogen at 1 site in Australia.
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 16 inclusion and 20 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 29 May 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 Australia. 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. 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?
Incidence of treatment-emergent adverse events (time frame: 3 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 29 May 2025.