Study of HTD4010 in Healthy Volunteers

Study Overview
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Brief Summary
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To investigate safety and tolerability of HTD4010 after single ascending doses (SAD) in healthy volunteers

Detailed Description
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Safety, tolerability and pharmacokinetics(PK) assessments are the outcome measure.

Official Title
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A First in Human, Randomized, Double-Blind Study to Assess Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Effects of HTD4010 in Healthy Participants

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: HTD4010


Participation Criteria
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Eligibility Criteria
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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: Systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg at screening. Pregnant or lactating women Participation in an investigational study within 30 days prior to dosing or 5 half-lives within the last dose of investigational product whichever is longer. Current use of any prescription or over-the-counter (OTC) medications, including herbal products and supplements, within 14 days prior to Day 1 or 5 half-lives, whichever is longer. Use of ≤2g paracetamol per day is allowed prior to and during the study at Investigator discretion. Any use of non-steroid anti-inflammatory drugs (NSAIDs) within 7 days prior to dosing. History of any major surgery within 6 months prior to Screening History of any serious adverse reaction or hypersensitivity to any of the product components. Use of parenterally administered proteins or antibodies within 12 weeks of screening. etc.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 50mg in SAD<br>single dose of 50mg HTD4010 or placebo injectable in healthy volunteers | Drug: HTD4010<br>* injectable solution<br>* Other names: analog of INGAP peptide;|
| Experimental: 100mg in SAD<br>single dose of 100mg HTD4010 or placebo injectable in healthy volunteers | Drug: HTD4010<br>* injectable solution<br>* Other names: analog of INGAP peptide;|
| Experimental: 200mg in SAD<br>single dose of 200mg HTD4010 or placebo injectable in healthy volunteers | Drug: HTD4010<br>* injectable solution<br>* Other names: analog of INGAP peptide;|
| Experimental: 300mg in SAD<br>single dose of 300mg HTD4010 or placebo injectable in healthy volunteers | Drug: HTD4010<br>* injectable solution<br>* Other names: analog of INGAP peptide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence, severity and causality of adverse events |  | One day in SAD |