First in Human, Single Ascending Dose Study
NCT05844592 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2023-05-06
Summary
The goal of this study is to evaluate the safety and tolerability of single ascending oral doses of INV-101 in healthy adult subjects.
Conditions
Interventions
- DRUG
-
INV-101
subjects will be randomized 3:1 ratio
Sponsors & Collaborators
-
Innovo Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Minjeong Kim, Master · New Drug development Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 19 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-04-21
- Primary Completion
- 2022-07-16
- Completion
- 2022-08-31
- FDA Drug
- Yes
Countries
- South Korea
Study Locations
More Related Trials
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative Colitis
NCT01164904 ·Status: TERMINATED ·Phase: PHASE1
-
A Study of a Single Dose of ASP3291 in Subjects With Ulcerative Colitis
NCT01320332 ·Status: COMPLETED ·Phase: PHASE1
-
Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease (IBD)
NCT01346826 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Evaluate IBI112 in the Treatment of Moderate to Severe Active Ulcerative Colitis
NCT05377580 ·Status: COMPLETED ·Phase: PHASE2
-
A Clinical Trial to Assess the Safety of SOR102 in Healthy Participants and Patients With Ulcerative Colitis
NCT06080048 ·Status: COMPLETED ·Phase: PHASE1
-
Single Ascending Dose and Multiple Ascending Dose Study in Healthy Participants and Proof of Mechanism Study in Patients With Ulcerative Colitis
NCT02864264 ·Status: TERMINATED ·Phase: PHASE1
-
A First-time in Human (FTIH) Study to Evaluate Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK4528287 in Healthy Participants
NCT06681181 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Effect of GSK1399686 in Patients With Mild to Moderately Active Ulcerative Colitis
NCT01036022 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of ENC1018 Capsules in Patients With Moderate-to-severe Active Ulcerative Colitis (UC)
NCT07062185 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn's Disease (CD)
NCT02749630 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of AC-101 Tablets in Participants With Moderate to Severe Active Ulcerative Colitis
NCT07083193 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis
NCT02065622 ·Status: COMPLETED ·Phase: PHASE3
-
Confirmatory Clinical Study in Active Ulcerative Colitis
NCT07296315 ·Status: RECRUITING ·Phase: PHASE2
-
A Phase 2 Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HRS-7085 Tablets in Patients With Inflammatory Bowel Disease
NCT07229950 ·Status: RECRUITING ·Phase: PHASE2
-
Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis
NCT04596293 ·Status: COMPLETED ·Phase: PHASE2
-
Study for Safety and Tolerability of TOP1288 Administered Rectally in Healthy and Ulcerative Colitis Subjects
NCT02463045 ·Status: COMPLETED ·Phase: PHASE1
-
Single Dose Escalation Trial to Evaluate the Safety, Tolerability Pharmacokinetics and Pharmacodynamics of GSK3050002
NCT01984047 ·Status: COMPLETED ·Phase: PHASE1
-
A Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study of E6007 in Healthy Subjects
NCT01221818 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1b Study to Assess the Safety and Anti-inflammatory Effects of Two Different Doses of SRT2104 in Patients With Ulcerative Colitis
NCT01453491 ·Status: COMPLETED ·Phase: PHASE1
-
SAD/MAD Study in Healthy Subjects and Adults With UC to Evaluate Safety, Tolerability, PK, PD of AMT-101
NCT04224857 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Safety and Effectiveness of JNJ-54781532 in Patients With Moderately to Severely Active Ulcerative Colitis
NCT01959282 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181.
NCT01290042 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis
NCT02435992 ·Status: COMPLETED ·Phase: PHASE3
-
A Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled Phase I Clinical Trial Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Oral Doses of HRS-7085 Tablets in Healthy Subjects, With Assessment of Food Effects
NCT06175949 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
Study of Vedolizumab Following Multiple Intravenous Doses in Patients With Ulcerative Colitis
NCT01177228 ·Status: COMPLETED ·Phase: PHASE2