First-In-Human Study of BBT-401-1S Following Single and Multiple Ascending Doses in Healthy Volunteers

NCT03482648 | Completed Phase 1 FDA Drug

• 1 other identifier: BBT401-UC-US01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ulcerative Colitis

Keywords

Pellino-1

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days after the last dose

Secondary Outcomes (4)

• Maximum plasma concentration (Cmax)

  72 hours after the last dose

• Area under the curve (AUC)

  72 hours after the last dose

• Maximum plasma concentration (Cmax) under fed conditions

  72 hours after the last dose

• Area under the curve (AUC) under fed conditions

  72 hours after the last dose

Study Arms (2)

Single Ascending Doses

EXPERIMENTAL

Drug: BBT-401-1S, Single dose; Drug: Placebo

Multiple Ascending Doses

EXPERIMENTAL

Drug: BBT-401-1S, Multiple doses; Drug: Placebo

Interventions

BBT-401-1S, Single dose DRUG

Single dose of BBT-401-1S, 7 dose levels, oral capsule

Single Ascending Doses

BBT-401-1S, Multiple doses DRUG

Multiple doses of BBT-401-1S, 7 days, 3 dose levels, oral capsule

Multiple Ascending Doses

Placebo DRUG

Placebo matched to BBT-401-1S, oral capsule

Multiple Ascending Doses; Single Ascending Doses

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Bridge Biotherapeutics, Inc.: lead
• KCRN Research, LLC: collaborator

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2018
• First Posted: March 29, 2018
• Study Start: March 20, 2018
• Primary Completion: September 26, 2018
• Study Completion: October 3, 2018
• Last Updated: July 21, 2021

Record last verified: 2021-07

Locations

US (1)