Study to Evaluate Safety and PK/PD of DA-3091 in Healthy Male Subjects
NCT01156779 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31
Last updated 2013-08-13
Summary
This Phase I clinical study is to evaluate the safety and tolerance of DA-3091 and to characterize the pharmacokinetic/pharmacodynamic of DA-3091 in healthy male subjects
Conditions
Interventions
- DRUG
-
SR-exenatide
Emulsion 0.5mg,1mg,2mg,4mg dosage (Dose-escalation) Single injection
Sponsors & Collaborators
-
Dong-A Pharmaceutical Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Kyung-Sang Yu, M.D., Ph.d · Seoul National University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-07-31
- Primary Completion
- 2012-04-30
Countries
- South Korea
Study Locations
More Related Trials
-
Assessment of the Safety, Tolerability and Pharmacodynamics After Administration of One Dose of AZD8601 to Male Patients With Type II Diabetes Mellitus (T2DM)
NCT02935712 ·Status: COMPLETED ·Phase: PHASE1
-
Phase IV Study With a 36-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin Therapy When Added to the Therapy of Japanese Patients With Type 2 Diabetes With Inadequate Glycemic Control on Insulin.
NCT02157298 ·Status: COMPLETED ·Phase: PHASE4
-
A Single-dose Trial to Investigate the Safety and Tolerability of XEN-D0501 in Patients With Diabetes Mellitus Type 2
NCT03278158 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus.
NCT06579105 ·Status: COMPLETED ·Phase: PHASE2
-
Randomized, Placebo-controlled, 2 Period, Single-blind, Sequential, Multiple Ascending Dose Study
NCT01956305 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus Receiving Sitagliptin
NCT02685345 ·Status: COMPLETED ·Phase: PHASE2
-
A Study in Healthy Male Volunteers to Investigate Different Doses of a New Drug for the Treatment of Metabolic Diseases
NCT01340911 ·Status: COMPLETED ·Phase: PHASE1
-
The Safety and Efficacy of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With T1DM
NCT02582814 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Test How SB756050 Affects Subjects With Type 2 Diabetes Mellitus After 6 Days of Dosing.
NCT00733577 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics and Safety/Tolerability Profiles of DA-2811 in Healthy Subjects
NCT04473417 ·Status: COMPLETED ·Phase: PHASE1
-
Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes
NCT00831779 ·Status: COMPLETED ·Phase: PHASE2
-
Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of NNC0113-0987 in Healthy Male Subjects
NCT01690169 ·Status: COMPLETED ·Phase: PHASE1
-
Clinical Trial to Evaluate the Efficacy and Safety of DA-2811 When Added to Ongoing Metformin Monotherapy in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control
NCT05743907 ·Status: COMPLETED ·Phase: PHASE4
-
Phase II Dose-Finding Study of SK-0403 With Type 2 Diabetes Mellitus
NCT00532506 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy and Safety of Pioglitazone 15mg or 30mg Add-on in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin
NCT04885712 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DS-1150b in Healthy Subjects and Subjects With Type-2 Diabetes Mellitus
NCT02004678 ·Status: COMPLETED ·Phase: PHASE1
-
The Efficacy and Safety of D745 Added to D150 Plus D759 Therapy in Patients with Type 2 Diabetes
NCT05566028 ·Status: COMPLETED ·Phase: PHASE3
-
Dose-finding of PB-119 Administered Subcutaneously Once-weekly Versus Placebo in Drug-naïve T2DM Subjects
NCT03520972 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 1 Multicenter, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Response of PE0139 Injection in Adult Subjects With Type 2 Diabetes Mellitus
NCT01835730 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Tolerability Study of MEDI0382 in Japanese Preobese or Obese Subjects With Type 2 Diabetes
NCT03645421 ·Status: COMPLETED ·Phase: PHASE2
-
Clinical Study to Assess the Pharmacokinetics, Safety and Tolerability of SRT2104 Administered to Normal Healthy Male Volunteers
NCT00933062 ·Status: COMPLETED ·Phase: PHASE1
-
A Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetics of D745, D759, and D150
NCT05928637 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Tolerability After Four Weeks of Treatment With AZD1656 in Patients With Type 2 Diabetes
NCT00856908 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Effect of add-on Pioglitazone or Dapagliflozin in Participants With Type 2 Diabetes Mellitus Inadequately Controlled by DPP-4 Inhibitor and Metformin Therapy
NCT03499704 ·Status: COMPLETED ·Phase: PHASE4
-
A Two-Part, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DS-7309 in Healthy Volunteers and Subjects With Type 2 Diabetes Mellitus
NCT01862939 ·Status: COMPLETED ·Phase: PHASE1