Study of HTD4010 in Healthy Volunteers

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

Sponsors

Lead Sponsor: HighTide Biopharma Pty Ltd

Source 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.

Overall Status Completed
Start Date October 2015
Completion Date March 2016
Primary Completion Date March 2016
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence, severity and causality of adverse events One day in SAD
Enrollment 32
Condition
Intervention

Intervention Type: Drug

Intervention Name: HTD4010

Description: injectable solution

Other Name: analog of INGAP peptide

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Janakan Krishnarajah, Doctor Principal Investigator Linear Clinical Research Limited
Location
Facility: Linear Clinical Research Limited
Location Countries

Australia

Verification Date

July 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: 50mg in SAD

Type: Experimental

Description: single dose of 50mg HTD4010 or placebo injectable in healthy volunteers

Label: 100mg in SAD

Type: Experimental

Description: single dose of 100mg HTD4010 or placebo injectable in healthy volunteers

Label: 200mg in SAD

Type: Experimental

Description: single dose of 200mg HTD4010 or placebo injectable in healthy volunteers

Label: 300mg in SAD

Type: Experimental

Description: single dose of 300mg HTD4010 or placebo injectable in healthy volunteers

Study Design Info

Allocation: Randomized

Intervention Model: Factorial Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov