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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: HTD4010

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Perth, Australia, WA6009
    • Linear Clinical Research Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 50mg in SAD; single dose of 50mg HTD4010 or placebo injectable in healthy volunteers	Drug: HTD4010; injectable solution; Other Names: analog of INGAP peptide
Experimental: 100mg in SAD; single dose of 100mg HTD4010 or placebo injectable in healthy volunteers	Drug: HTD4010; injectable solution; Other Names: analog of INGAP peptide
Experimental: 200mg in SAD; single dose of 200mg HTD4010 or placebo injectable in healthy volunteers	Drug: HTD4010; injectable solution; Other Names: analog of INGAP peptide
Experimental: 300mg in SAD; single dose of 300mg HTD4010 or placebo injectable in healthy volunteers	Drug: HTD4010; injectable solution; Other Names: analog of INGAP peptide

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: HighTide Biopharma Pty Ltd
• Investigators: Principal Investigator: Janakan Krishnarajah, Doctor, Linear Clinical Research Limited

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: August 31, 2015
• First Submitted That Met QC Criteria: September 1, 2015
• First Posted (Estimate): September 2, 2015

Study Record Updates

• Last Update Posted (Actual): July 27, 2020
• Last Update Submitted That Met QC Criteria: July 23, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 4010.PCT001