Study of HTD4010 in Healthy Volunteers

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: HTD4010

• Registration Number: NCT02538848
• Lead Sponsor: HighTide Biopharma Pty Ltd

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2015-08-31
• Study First Submitted QC: 2015-09-01
• Study First Posted: 2015-09-02
• Study Start: 2015-10
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-23
• Last Update Posted: 2020-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Body mass index (BMI) ≥18.0 to ≤ 30.0 kg/m2

2. Non-diabetic, fasting plasma glucose < 5.6 mmol/L

3. 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.

4. Ability to provide written informed consent.

Exclusion Criteria

1. Systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg at screening.
2. Pregnant or lactating women
3. 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.
4. 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.
5. Any use of non-steroid anti-inflammatory drugs (NSAIDs) within 7 days prior to dosing.
6. History of any major surgery within 6 months prior to Screening
7. History of any serious adverse reaction or hypersensitivity to any of the product components.
8. Use of parenterally administered proteins or antibodies within 12 weeks of screening.

etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
50mg in SAD	HTD4010	single dose of 50mg HTD4010 or placebo injectable in healthy volunteers
100mg in SAD	HTD4010	single dose of 100mg HTD4010 or placebo injectable in healthy volunteers
200mg in SAD	HTD4010	single dose of 200mg HTD4010 or placebo injectable in healthy volunteers
300mg in SAD	HTD4010	single dose of 300mg HTD4010 or placebo injectable in healthy volunteers

Primary Outcome Measures

Name	Time	Method
Incidence, severity and causality of adverse events	One day in SAD

Trial Locations

Locations (1)

Linear Clinical Research Limited; 🇦🇺 Perth, Australia