AsthmaPhase 1NCT03652038
Single and Multiple Ascending Dose Study of TD-8236 by Inhalation
A Phase 1 study testing TD-8236 in people with Asthma, run by Theravance Biopharma at 2 sites in United Kingdom.
Trial summary
This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 3 parts: Part A is a single ascending dose (SAD) study in healthy subjects, Part B is a multiple ascending dose (MAD) study in subjects with stable, mild asthma, and Part C (Biomarker) is a multiple dose study in subjects… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- TD-8236
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 7 Nov 2018to 13 Jul 2020
- 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
- Male or female, 18 - 60 years old
- Willing and able to give informed consent and comply with the study
- Body mass index (BMI) 18 to 32 kg/m2 and weighs at least 50 kg
- Women of child bearing potential must have a negative pregnancy test and use a highly efficient birth control method
- Pre-bronchodilator FEV ≥ 70% predicted for MAD cohorts and >40% predicted for biomarker cohorts
- Treatment with inhaled corticosteroids with or without long acting beta agonists
- Additional inclusion criteria apply
Who cannot join
- Positive for hepatitis A, B or C, HIV or tuberculosis
- Clinically significant abnormalities of laboratory evaluations
- Have abnormal ECG measurements
- Any sign of respiratory tract infection within 6 weeks of screening
- Have a current bacterial, parasitic, fungal or viral infection
- Uses or have used tobacco or nicotine-containing products within 6 months prior to screening
- Additional exclusion criteria apply
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Theravance Biopharma Investigational Site
Belfast, Northern Ireland
Theravance Biopharma Investigational Site
Manchester, England, M23 9QZ
About this study
Official title: A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, 3-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TD-8236 by Inhalation of Single Ascending Doses in Healthy Subjects (Part A) and Multiple Ascending Doses in Subjects With Stable, Mild Asthma (Part B), and Stable, Moderate-to-Severe Asthma (Part C)
This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 3 parts: Part A is a single ascending dose (SAD) study in healthy subjects, Part B is a multiple ascending dose (MAD) study in subjects with stable, mild asthma, and Part C (Biomarker) is a multiple dose study in subjects with stable, moderate-to-severe asthma.
- Conditions
- Asthma
- Being tested
- TD-8236, Placebo
- Keywords
- Single ascending dose, SAD, Multiple ascending dose, MAD, Phase 1, first-in-human, TD-8236, asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD-8236Drug
Study drug to be administered via inhaler device
PlaceboDrug
Placebo to be administered via inhaler device
| Study group | Role | What they receive |
|---|---|---|
| TD-8236 for SAD (Part A) | Experimental | 6 out of 8 subjects per cohort (up to 5 cohorts) will be randomized to receive TD-8236 Receives: Drug: TD-8236 |
| Placebo for SAD (Part A) | Placebo comparator | 2 out of 8 subjects per cohort (up to 5 cohorts) will be randomized to receive placebo Receives: Drug: Placebo |
| TD-8236 for MAD (Part B) | Experimental | 6 out of 8 subjects per cohort (up to 6 cohorts) will be randomized to receive TD-8236. Receives: Drug: TD-8236 |
| Placebo for MAD (Part B) | Placebo comparator | 2 out of 8 subjects per cohort (up to 6 cohorts) will be randomized to receive placebo. Receives: Drug: Placebo |
| TD-8236 for Biomarker (Part C) | Experimental | 8 subjects in each of 2 biomarker cohorts will be randomized to receive TD-8236. Receives: Drug: TD-8236 |
| Placebo for Biomarker (Part C) | Placebo comparator | 8 subjects in 1 biomarker cohort will be randomized to receive placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of SAD of TD-8236 by assessing the number, severity and type of treatment emergent adverse events
Measured: Day 1 through Day 8
To assess the safety and tolerability of MAD of TD-8236 by assessing the number, severity and type of treatment emergent adverse events
Measured: Day 1 through Day 14
Secondary outcomes (6)
Pharmacokinetics (PK) of TD-8236 when given as a Single Ascending Dose (SAD): Area under the plasma concentration-time curve (AUC)
Multiple PK variables of TD-8236 will be assessed during SAD and may include, but are not limited to:
Area under the plasma concentration-time curve (AUC)
Measured: Day 1 through Day 4
Pharmacokinetics (PK) of TD-8236 when given as a Single Ascending Dose (SAD): Maximum observed concentration (Cmax)
Multiple PK variables of TD-8236 will be assessed during SAD and may include, but are not limited to:
Maximum observed concentration (Cmax)
Measured: Day 1 through Day 4
Pharmacokinetics (PK) of TD-8236 when given as a Single Ascending Dose (SAD): Time to reach maximum observed concentration (Tmax)
Multiple PK variables of TD-8236 will be assessed during SAD and may include, but are not limited to:
Time to reach maximum observed concentration (Tmax)
Measured: Day 1 through Day 4
Pharmacokinetics (PK) of TD-8236 when given as a Multiple Ascending Dose (MAD): Area under the plasma concentration-time curve (AUC)
Multiple PK variables of TD-8236 will be assessed during MAD and may include, but are not limited to:
Area under the plasma concentration-time curve (AUC)
Measured: Day 1 through Day 9
Pharmacokinetics (PK) of TD-8236 when given as a Multiple Ascending Dose (MAD): Maximum observed concentration (Cmax)
Multiple PK variables of TD-8236 will be assessed during MAD and may include, but are not limited to:
Maximum observed concentration (Cmax)
Measured: Day 1 through Day 9
Pharmacokinetics (PK) of TD-8236 when given as a Multiple Ascending Dose (MAD): Time to reach maximum observed concentration (Tmax)
Multiple PK variables of TD-8236 will be assessed during MAD and may include, but are not limited to:
Time to reach maximum observed concentration (Tmax)
Measured: Day 1 through Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start7 Nov 2018
- Primary completion13 Jul 2020
- Study completion13 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theravance Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Theravance Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652038
- Sponsor's protocol ID
- 0175
- Other IDs
- 2018-001260-38, 2018
- Status last verified
- Sep 2021
- First submitted
- 20 Aug 2018
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, 3-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TD-8236 by Inhalation of Single Ascending Doses in Healthy Subjects (Part A) and Multiple Ascending Doses in Subjects With Stable, Mild Asthma (Part B), and Stable, Moderate-to-Severe Asthma (Part C)
- ClinicalTrials.gov ID
- NCT03652038
- Acronym / sponsor ID
- 0175
- Conditions
- Asthma
- Keywords
- Single ascending dose, SAD, Multiple ascending dose, MAD, Phase 1, first-in-human, TD-8236, asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Theravance BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 13 Jul 2020 (actual)
- Study completion
- 13 Jul 2020 (actual)
- First posted
- 29 Aug 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 is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 3 parts: Part A is a single ascending dose (SAD) study in healthy subjects, Part B is a multiple ascending dose (MAD) study in subjects with stable, mild asthma, and Part C (Biomarker) is a multiple dose study in subjects with stable, moderate-to-severe asthma.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| TD-8236 for SAD (Part A) | Experimental | Drug: TD-82366 out of 8 subjects per cohort (up to 5 cohorts) will be randomized to receive TD-8236 |
| Placebo for SAD (Part A) | Placebo comparator | Drug: Placebo2 out of 8 subjects per cohort (up to 5 cohorts) will be randomized to receive placebo |
| TD-8236 for MAD (Part B) | Experimental | Drug: TD-82366 out of 8 subjects per cohort (up to 6 cohorts) will be randomized to receive TD-8236. |
| Placebo for MAD (Part B) | Placebo comparator | Drug: Placebo2 out of 8 subjects per cohort (up to 6 cohorts) will be randomized to receive placebo. |
| TD-8236 for Biomarker (Part C) | Experimental | Drug: TD-82368 subjects in each of 2 biomarker cohorts will be randomized to receive TD-8236. |
| Placebo for Biomarker (Part C) | Placebo comparator | Drug: Placebo8 subjects in 1 biomarker cohort will be randomized to receive placebo. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female, 18 - 60 years old
- Willing and able to give informed consent and comply with the study
- Body mass index (BMI) 18 to 32 kg/m2 and weighs at least 50 kg
- Women of child bearing potential must have a negative pregnancy test and use a highly efficient birth control method
- Pre-bronchodilator FEV ≥ 70% predicted for MAD cohorts and >40% predicted for biomarker cohorts
Key exclusion criteria (7 listed)
- Positive for hepatitis A, B or C, HIV or tuberculosis
- Clinically significant abnormalities of laboratory evaluations
- Have abnormal ECG measurements
- Any sign of respiratory tract infection within 6 weeks of screening
- Have a current bacterial, parasitic, fungal or viral infection
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 |
|---|---|---|
| TD-8236Study drug to be administered via inhaler device | Drug | TD-8236 for Biomarker (Part C), TD-8236 for MAD (Part B), TD-8236 for SAD (Part A) |
| PlaceboPlacebo to be administered via inhaler device | Drug | Placebo for Biomarker (Part C), Placebo for MAD (Part B), Placebo for SAD (Part A) |
Primary outcome
To assess the safety and tolerability of SAD of TD-8236 by assessing the number, severity and type of treatment emergent adverse events
Time frame: Day 1 through Day 8
To assess the safety and tolerability of MAD of TD-8236 by assessing the number, severity and type of treatment emergent adverse events
Time frame: Day 1 through Day 14
6 secondary outcomes
Pharmacokinetics (PK) of TD-8236 when given as a Single Ascending Dose (SAD): Area under the plasma concentration-time curve (AUC)
Time frame: Day 1 through Day 4
Pharmacokinetics (PK) of TD-8236 when given as a Single Ascending Dose (SAD): Maximum observed concentration (Cmax)
Time frame: Day 1 through Day 4
Pharmacokinetics (PK) of TD-8236 when given as a Single Ascending Dose (SAD): Time to reach maximum observed concentration (Tmax)
Time frame: Day 1 through Day 4
Pharmacokinetics (PK) of TD-8236 when given as a Multiple Ascending Dose (MAD): Area under the plasma concentration-time curve (AUC)
Time frame: Day 1 through Day 9
Pharmacokinetics (PK) of TD-8236 when given as a Multiple Ascending Dose (MAD): Maximum observed concentration (Cmax)
Time frame: Day 1 through Day 9
Pharmacokinetics (PK) of TD-8236 when given as a Multiple Ascending Dose (MAD): Time to reach maximum observed concentration (Tmax)
Time frame: Day 1 through Day 9
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 30 Sep 2021.
- Individual participant dataSharing planned: No. Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
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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.
Medical Monitor study director
Theravance Biopharma
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TD-8236 in people with Asthma, run by Theravance Biopharma at 2 sites in United Kingdom.
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 7 inclusion and 7 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 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
To assess the safety and tolerability of SAD of TD-8236 by assessing the number, severity and type of treatment emergent adverse events (time frame: Day 1 through Day 8). 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 30 Sep 2021.