A Phase 1 Double-blind, Randomized, Placebo-Controlled, Staggered, Single and Multiple Ascending Dose, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 in Subjects with Moderate to Severe Ulcerative Colitis

Completed

• Conditions: inflamatory bowel disease; Ulcerative Colitis; 10017969

• Registration Number: NL-OMON40621
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

1. Have the ability to understand and sign a written informed consent
form, which must be obtained prior to initiation of study procedures
2. Males or non-pregnant, non-lactating females, ages 18 to 65 years,
inclusive
3. Females of childbearing potential (see definition in Section 7.9) must
have a negative pregnancy test at Screening and Baseline.
4. All sexually active female subjects, of childbearing potential, must
agree to use a highly effective method of contraception during
heterosexual intercourse from Screening to study completion, and up
to 90 days post last dose of the study drug.
5. Male subjects who are sexually active are required to use barrier
contraception (condom with spermicide) during heterosexual
intercourse from Screening to study completion, and up to 90 days
post last dose of the study drug.
6. Documented diagnosis of UC with a minimum disease extent of
15 cm from the anal verge
7. Mayo Score:
* SAD cohort: Minimum modified Mayo Score of 3 (score > 3),
with a rectal bleeding and stool frequency sub-score of at least 1
* MAD cohort: Minimum Mayo Score of 6 (score > 6), with a
Mayo endoscopic sub-score of at least 2
8. Laboratory parameters:
* Hepatic panel (AST, ALT, total bilirubin, direct bilirubin,
alkaline phosphatase, LDH) * 2 times the ULN
* Serum creatinine * 1.5 times the ULN
* Hemoglobin * 10 g/dL (both males and females)
* Absolute neutrophil count (ANC) * 1.5 x 109/L (1,500 mm3)
* Platelets * 100 x 109/L

Exclusion Criteria

1. Pregnant or lactating subjects
2. Known hypersensitivity to the study investigational medicinal
products, the metabolites or formulation excipients.
3. Exhibit severe UC as defined by the following criteria:
* *6 bloody stools daily AND one or more of the following:
* Oral temperature > 100.3°F ( or 38°C)
* Pulse > 90 beats/minute
* Hemoglobin < 10 g/dL (both males and females)
4. Current use of oral corticosteroids at a dose equivalent to
> 20 mg/day of prednisone
5. Any dose adjustment in oral corticosteroids or oral
immunosuppressants (6-MP, Azathioprine) , or oral 5-ASA
compounds within 30 days of Baseline
6. Use of rectal formulations of 5-ASA compounds or corticosteroids
within 2 weeks prior to randomization
7. Crohn*s disease or indeterminate colitis
8. History of colectomy, partial colectomy, or dysplasia on biopsy
9. Stool sample positive for Clostridium difficile (C. difficile) toxin, E.
coli, Salmonella, Shigella, Campylobacter or Yersinia
10. Treatment with Infliximab, Adalimumab, Natalizumab, Golimumab,
Vedolizumab or Certolizumab within 8 weeks of randomization
11. Clinically significant active infection
12. Chronic medical or psychiatric problem that may interfere with
subject*s ability to comply with study procedures
13. Alcohol or drug abuse in the opinion of the Investigator
14. History of malignancy within the last 5 years except for patients who
have been treated for non-melanoma skin cancer or cervical
carcinoma in situ
15. Any other investigational therapy or investigational biologics use
within 8 weeks of randomization
16. Any chronic medical condition (including, but not limited to, cardiac
or pulmonary disease) that, in the opinion of the Investigator, would
make the subject unsuitable for the study or would prevent
compliance with the study protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified