Study of HTD4010 in Healthy Volunteers

NCT02538848 | Completed Phase 1 DMC

• 1 other identifier: 4010.PCT001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Incidence, severity and causality of adverse events

  One day in SAD

Study Arms (4)

50mg in SAD

EXPERIMENTAL

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

Drug: HTD4010

100mg in SAD

EXPERIMENTAL

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

Drug: HTD4010

200mg in SAD

EXPERIMENTAL

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

Drug: HTD4010

300mg in SAD

EXPERIMENTAL

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

Drug: HTD4010

Interventions

HTD4010 DRUG

injectable solution

Also known as: analog of INGAP peptide

100mg in SAD; 200mg in SAD; 300mg in SAD; 50mg in SAD

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HighTide Biopharma Pty Ltd: lead

Study Sites (1)

Linear Clinical Research Limited

Perth, WA6009, Australia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Janakan Krishnarajah, Doctor

  Linear Clinical Research Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: September 2, 2015
• Study Start: October 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 27, 2020

Record last verified: 2020-07

Locations

AU (1)