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To investigate safety and tolerability of HTD4010 after single ascending doses (SAD) in healthy volunteers
Safety, tolerability and pharmacokinetics(PK) assessments are the outcome measure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50mg in SAD | Experimental | single dose of 50mg HTD4010 or placebo injectable in healthy volunteers |
|
| 100mg in SAD | Experimental | single dose of 100mg HTD4010 or placebo injectable in healthy volunteers |
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| 200mg in SAD | Experimental | single dose of 200mg HTD4010 or placebo injectable in healthy volunteers |
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| 300mg in SAD | Experimental | single dose of 300mg HTD4010 or placebo injectable in healthy volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HTD4010 | Drug | injectable solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, severity and causality of adverse events | One day in SAD |
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For volunteers in SAD:
Inclusion Criteria:
Body mass index (BMI) ≥18.0 to ≤ 30.0 kg/m2
Non-diabetic, fasting plasma glucose < 5.6 mmol/L
Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for ≥12 months.
Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the participant and his partner must be using an acceptable, highly effective, contraceptive method from screening and for a period of 60 days after the last dose of Study Drug.
Ability to provide written informed consent.
Exclusion Criteria:
etc.
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| Name | Affiliation | Role |
|---|---|---|
| Janakan Krishnarajah, Doctor | Linear Clinical Research Limited | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linear Clinical Research Limited | Perth | WA6009 | Australia |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| D004700 | Endocrine System Diseases |