Study of HTD4010 in Healthy Volunteers

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02538848
• Other study ID #: 4010.PCT001
• Status: Completed
• Phase: Phase 1
• Start date: October 2015
• Est. completion date: March 2016

Study information

• Verified date: July 2020
• Source: HighTide Biopharma Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

For volunteers in SAD:

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• HTD4010
injectable solution

Locations

Country	Name	City	State
Australia	Linear Clinical Research Limited	Perth

Sponsors (1)

Lead Sponsor	Collaborator
HighTide Biopharma Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence, severity and causality of adverse events		One day in SAD