Ulcerative ColitisPhase 1NCT03482648
First-In-Human Study of BBT-401-1S Following Single and Multiple Ascending Doses in Healthy Volunteers
A Phase 1 study testing BBT-401-1S, Single dose and BBT-401-1S, Multiple doses in people with Ulcerative Colitis, run by Bridge Biotherapeutics, Inc. at 1 site in United States.
Trial summary
This clinical trial is the first-in-human study of BBT-401-1S. The purpose of this phase 1 study is to assess the safety and tolerability of single and multiple ascending oral doses of BBT-401-1S in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- BBT-401-1S, Single dose and BBT-401-1S, Multiple doses
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2018to 3 Oct 2018
- 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male and/or female (non-childbearing potential only), 19 to 55 years of age, inclusive, at screening.
- Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dose and throughout the study.
- Body mass index (BMI) ≥ 18.5 and ≤ 32.0 (kg/m2) at screening and weight ≥ 50 kg at screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI.
- No clinically significant history or presence of ECG findings as judged by the PI or qualified designee at screening and check-in.
- For a female, must be of non-childbearing potential and therefore must have undergone one of the following sterilization procedures, at least 6 months prior to the first dose:
Show all 13Show fewer
- hysteroscopic sterilization;
- bilateral tubal ligation or bilateral salpingectomy;
- hysterectomy;
- bilateral oophorectomy; or be postmenopausal with amenorrhea for at least 1 year prior to the first dose and follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status as per PI judgment.
- A non-vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study drug. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to the first dose of study drug. A male who has been vasectomized less than 4 months prior to the first dose must follow the same restrictions as a non-vasectomized male).
- If male, must agree to not donate sperm from the first dose until 90 days after dosing.
- Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
Who cannot join
- Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
- History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first dose or regular alcohol consumption within 6 months prior to the first dose with an average weekly intake of greater than 21 glasses/units per week for males or 14 glasses/units per week for females, with one unit = 150 mL of wine or 360 mL of beer or 45 mL of 45% alcohol.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drug(s) or related compounds.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
Show all 29Show fewer
- Active or latent tuberculosis.
- Estimated creatinine clearance <80 mL/min at screening.
- Liver function tests (serum ALT, AST, alkaline phosphatase) and serum bilirubin (total and direct) > ULN.
- Absolute neutrophil count < 1500 cells/mm3.
- White blood cell count < 3500 cells/mm3.
- Haemoglobin levels < 0.5 mg/dL below the lower limit of normal.
- Seated heart rate is lower than 40 bpm or higher than 99 bpm at screening.
- Female subjects of childbearing potential.
- Female subjects who are pregnant or lactating.
- Positive urine drug or alcohol results at screening or check-in.
- Positive urine cotinine at screening.
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
- Unable to refrain from or anticipates the use of any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning approximately 14 days prior to the first dose and throughout the study.. Hormone replacement therapy will not be allowed. After first dosing, acetaminophen (up to 2 g per 24 hours) may be administered at the discretion of the PI or designee.
- Has been on a diet incompatible with the on-study diet, in the opinion of the PI, within the 28 days prior to the first dose and throughout the study.
- Donation of blood or significant blood loss within 56 days prior to the first dose.
- Plasma donation within 7 days prior to the first dose.
- Exposure to more than four new chemical entities within 12 months prior to first dosing day.
- The subject has participated in a clinical trial and has received an investigational product within 30 days, or 5 half-lives of the investigational product (whichever is longer) of the first dose of study drug in the current study.
- Any condition or circumstance, in the opinion of the PI, which may make the subject unlikely to complete the study or comply with study procedures and requirements, or may pose a risk to the subject's safety.
- Subject has recent history (within 2 weeks of Day -1) of less than 1 bowel movement every 2 days.
- Subject has recent history (within 2 weeks of Day -1) of abnormal bowel movements, such as diarrhea, loose stools, or constipation.
- Stage 1 Only:
- Is lactose intolerant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Novel Oral Peptide BBT-401-1S Following Single and Multiple Ascending Doses in Healthy Adult Subjects
This clinical trial is the first-in-human study of BBT-401-1S. The purpose of this phase 1 study is to assess the safety and tolerability of single and multiple ascending oral doses of BBT-401-1S in healthy adult subjects.
- Conditions
- Ulcerative Colitis
- Being tested
- BBT-401-1S, Single dose, BBT-401-1S, Multiple doses, Placebo
- Keywords
- Pellino-1
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBT-401-1S, Single doseDrug
Single dose of BBT-401-1S, 7 dose levels, oral capsule
BBT-401-1S, Multiple dosesDrug
Multiple doses of BBT-401-1S, 7 days, 3 dose levels, oral capsule
PlaceboDrug
Placebo matched to BBT-401-1S, oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Doses | Experimental | Not described Receives: Drug: BBT-401-1S, Single dose; Drug: Placebo |
| Multiple Ascending Doses | Experimental | Not described Receives: Drug: BBT-401-1S, Multiple doses; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and severity of treatment emergent adverse events (TEAEs)
To assess the safety and tolerability of single and multiple ascending oral doses of BBT-401-1S in healthy adult subjects.
Measured: 7 days after the last dose
Secondary outcomes (4)
Maximum plasma concentration (Cmax)
To assess Cmax of single and multiple ascending oral doses of BBT-401-1S in healthy adult subjects.
Measured: 72 hours after the last dose
Area under the curve (AUC)
To assess AUC of single and multiple ascending oral doses of BBT-401-1S in healthy adult subjects.
Measured: 72 hours after the last dose
Maximum plasma concentration (Cmax) under fed conditions
To assess Cmax of single oral dose under fed conditions
Measured: 72 hours after the last dose
Area under the curve (AUC) under fed conditions
To assess AUC of single oral dose under fed conditions
Measured: 72 hours after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start20 Mar 2018
- Primary completion26 Sep 2018
- Study completion3 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bridge Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KCRN Research, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482648
- Sponsor's protocol ID
- BBT401-UC-US01
- Status last verified
- Jul 2021
- First submitted
- 17 Mar 2018
- Last updated
- 21 Jul 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Novel Oral Peptide BBT-401-1S Following Single and Multiple Ascending Doses in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03482648
- Acronym / sponsor ID
- BBT401-UC-US01
- Conditions
- Ulcerative Colitis
- Keywords
- Pellino-1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bridge Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- KCRN Research, LLC
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 26 Sep 2018 (actual)
- Study completion
- 3 Oct 2018 (actual)
- First posted
- 29 Mar 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 clinical trial is the first-in-human study of BBT-401-1S. The purpose of this phase 1 study is to assess the safety and tolerability of single and multiple ascending oral doses of BBT-401-1S in healthy adult subjects.
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 Ascending Doses | Experimental | Drug: BBT-401-1S, Single dose, Drug: Placebo |
| Multiple Ascending Doses | Experimental | Drug: BBT-401-1S, Multiple doses, Drug: Placebo |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Healthy adult male and/or female (non-childbearing potential only), 19 to 55 years of age, inclusive, at screening.
- Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dose and throughout the study.
- Body mass index (BMI) ≥ 18.5 and ≤ 32.0 (kg/m2) at screening and weight ≥ 50 kg at screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI.
- No clinically significant history or presence of ECG findings as judged by the PI or qualified designee at screening and check-in.
Key exclusion criteria (29 listed)
- Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
- History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first dose or regular alcohol consumption within 6 months prior to the first dose with an average weekly intake of greater than 21 glasses/units per week for males or 14 glasses/units per week for females, with one unit = 150 mL of wine or 360 mL of beer or 45 mL of 45% alcohol.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drug(s) or related compounds.
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 |
|---|---|---|
| BBT-401-1S, Single doseSingle dose of BBT-401-1S, 7 dose levels, oral capsule | Drug | Single Ascending Doses |
| BBT-401-1S, Multiple dosesMultiple doses of BBT-401-1S, 7 days, 3 dose levels, oral capsule | Drug | Multiple Ascending Doses |
| PlaceboPlacebo matched to BBT-401-1S, oral capsule | Drug | Multiple Ascending Doses, Single Ascending Doses |
Primary outcome
The number and severity of treatment emergent adverse events (TEAEs)
Time frame: 7 days after the last dose
To assess the safety and tolerability of single and multiple ascending oral doses of BBT-401-1S in healthy adult subjects.
4 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: 72 hours after the last dose
Area under the curve (AUC)
Time frame: 72 hours after the last dose
Maximum plasma concentration (Cmax) under fed conditions
Time frame: 72 hours after the last dose
Area under the curve (AUC) under fed conditions
Time frame: 72 hours after the last 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 21 Jul 2021.
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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 BBT-401-1S, Single dose and BBT-401-1S, Multiple doses in people with Ulcerative Colitis, run by Bridge Biotherapeutics, Inc. 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 13 inclusion and 29 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 21 Jul 2021. 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. 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?
The number and severity of treatment emergent adverse events (TEAEs) (time frame: 7 days after the last 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 21 Jul 2021.