Study of HTD4010 in Healthy Volunteers

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

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.